Back to resultsA Randomized Control Trial of a Responsive Parenting Intervention to Support Healthy Brain Development and Self-regulation in Toddlers Born Preterm
Primary Purpose
Premature Birth
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PALS intervention condition
Control condition
Sponsored by
About this trial
This is an interventional prevention trial for Premature Birth
Eligibility Criteria
Inclusion Criteria:
- Maternal age over 18-years when child was born
Exclusion Criteria:
- presence of known/suspected congenital anomalies including chromosomal or complex congenital heart disease
- congenital infection including TORCH (Toxoplasmosis, Rubella, Cytomegalovirus, Herpes Simplex and others),untreated maternal HIV, or maternal syphilis
- bilateral grade 3/4 intraventricular hemorrhage,intraparenchymal hemorrhage, hydrocephalus
- Cerebral palsy with Gross Motor Function Classification of III or higher
- blindness-
- deafness
- Current maternal drug use or maternal drug use during pregnancy
- families who reside outside the catchment area (>1 hour drive from the Texas Medical Center)
- Child with contraindication for MRI. If the mother of the child is pregnant, thinks she might be pregnant, or has a contraindication for MRI, another relative of the child will be asked to assist with the MRIs
Sites / Locations
- The University of Texas Health Science Center at HoustonRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PALS intervention condition
Control condition
Arm Description
Outcomes
Primary Outcome Measures
Change in Parental contingent responsiveness as measured by the Parent-child Toy Play Observation
In this task the child will interact with their parent in a "free play" task for 10 minutes with a set of standardized toys, and the interaction will be videotaped. Parents are asked to play with their children in "typical ways" with a few constraints (e.g., television must be off). Behavior will be coded and assigned a score of how of 1-5 which indicates how often the assessed behavior occurs: 5 (Almost Always); 4 (greater than half the time); 3 (half the time); 2 (less than half the time); 1 (None of the time).
Change in Parental warm sensitivity (display of positive affect) as measured by the Parent-child Toy Play Observation
In this task the child will interact with their parent in a "free play" task for 10 minutes with a set of standardized toys, and the interaction will be videotaped. Parents are asked to play with their children in "typical ways" with a few constraints (e.g., television must be off). Behavior will be coded and assigned a score of how of 1-5 which indicates how often the assessed behavior occurs: 5 (Almost Always); 4 (greater than half the time); 3 (half the time); 2 (less than half the time); 1 (None of the time).
Change in Parental warm sensitivity (warmth) as measured by the Parent-child Toy Play Observation
In this task the child will interact with their parent in a "free play" task for 10 minutes with a set of standardized toys, and the interaction will be videotaped. Parents are asked to play with their children in "typical ways" with a few constraints (e.g., television must be off). Behavior will be coded and assigned a score of how of 1-5 which indicates how often the assessed behavior occurs: 5 (Almost Always); 4 (greater than half the time); 3 (half the time); 2 (less than half the time); 1 (None of the time).
Change in Parental maintaining of child's signals and interests as measured by the Parent-child Toy Play Observation
In this task the child will interact with their parent in a "free play" task for 10 minutes with a set of standardized toys, and the interaction will be videotaped. Parents are asked to play with their children in "typical ways" with a few constraints (e.g., television must be off). Behavior will be coded and assigned a score of how of 1-5 which indicates how often the assessed behavior occurs: 5 (Almost Always); 4 (greater than half the time); 3 (half the time); 2 (less than half the time); 1 (None of the time).
Change in Parental verbal scaffolding as measured by the Parent-child Toy Play Observation
In this task the child will interact with their parent in a "free play" task for 10 minutes with a set of standardized toys, and the interaction will be videotaped. Parents are asked to play with their children in "typical ways" with a few constraints (e.g., television must be off). Behavior will be coded and assigned a score of how of 1-5 which indicates how often the assessed behavior occurs: 5 (Almost Always); 4 (greater than half the time); 3 (half the time); 2 (less than half the time); 1 (None of the time).
Change in Child attentional engagement (engagement with environment) as measured by the Parent-child Toy Play Observation
In this task the child will interact with their parent in a "free play" task for 10 minutes with a set of standardized toys, and the interaction will be videotaped. Parents are asked to play with their children in "typical ways" with a few constraints (e.g., television must be off). Behavior will be coded and assigned a score of how of 1-5 which indicates how often the assessed behavior occurs: 5 (Almost Always); 4 (greater than half the time); 3 (half the time); 2 (less than half the time); 1 (None of the time).
Change in Child attentional engagement (social engagement) as measured by the Parent-child Toy Play Observation
In this task the child will interact with their parent in a "free play" task for 10 minutes with a set of standardized toys, and the interaction will be videotaped. Parents are asked to play with their children in "typical ways" with a few constraints (e.g., television must be off). Behavior will be coded and assigned a score of how of 1-5 which indicates how often the assessed behavior occurs: 5 (Almost Always); 4 (greater than half the time); 3 (half the time); 2 (less than half the time); 1 (None of the time).
Change in Child emotional regulation as measured by the Parent-child Toy Play Observation
In this task the child will interact with their parent in a "free play" task for 10 minutes with a set of standardized toys, and the interaction will be videotaped. Parents are asked to play with their children in "typical ways" with a few constraints (e.g., television must be off). Behavior will be coded and assigned a score of how of 1-5 which indicates how often the assessed behavior occurs: 5 (Almost Always); 4 (greater than half the time); 3 (half the time); 2 (less than half the time); 1 (None of the time).
Change in Child cooperation as measured by the Parent-child Toy Play Observation
In this task the child will interact with their parent in a "free play" task for 10 minutes with a set of standardized toys, and the interaction will be videotaped. Parents are asked to play with their children in "typical ways" with a few constraints (e.g., television must be off). Behavior will be coded and assigned a score of how of 1-5 which indicates how often the assessed behavior occurs: 5 (Almost Always); 4 (greater than half the time); 3 (half the time); 2 (less than half the time); 1 (None of the time).
Change in Child emotional regulation (proximity seeking behaviors) as assessed by score on Waiting Task
This task measures child frustration and parenting behaviors related to child's frustration. During this assessment the assessor provides the parent paperwork to complete and places an elaborately wrapped gift on the table in front of the child. The parent is instructed to have the child wait to open the gift until the assessor returns to the room and then the parent and child are left alone in a room for 8 minutes. Behavior is coded and scored.A score of 1 to 5 will be assigned to indicate how often the behavior occurred, as follows: 1 = 0 reaches; 2 = 1 - 2 reaches that are 15sec. sustained; 3 = 3 reaches that are 30sec. sustained; 4 = 4 Individually scored reaches that are 45sec. sustained; 5 = 5 or more reaches that are 60sec.
Change in Child emotional regulation (venting/aggression/distress behaviors) as assessed by score on Waiting Task
This task measures child frustration and parenting behaviors related to child's frustration. During this assessment the assessor provides the parent paperwork to complete and places an elaborately wrapped gift on the table in front of the child. The parent is instructed to have the child wait to open the gift until the assessor returns to the room and then the parent and child are left alone in a room for 8 minutes. Behavior is coded and scored. A score of 1 to 5 will be assigned to indicate how often the behavior occurred, as follows: 1 = did not happen; 2 = 1 brief instance -15 sec. sustained; 3 = 2 - 3 times -30 sec. sustained; 4 = ¾ instances - 45 sec. sustained; 5 = spends most of minute - >45 sec.
Change in Child emotional regulation (disengaged behavior) as assessed by score on Waiting Task
This task measures child frustration and parenting behaviors related to child's frustration. During this assessment the assessor provides the parent paperwork to complete and places an elaborately wrapped gift on the table in front of the child. The parent is instructed to have the child wait to open the gift until the assessor returns to the room and then the parent and child are left alone in a room for 8 minutes. Behavior is coded and scored. A score of 1 to 5 will be assigned to indicate how often the behavior occurred, as follows: 1 = 0 sec.; 2 = 15 sec. sustained; 3 = 30 sec sustained; 4 = 45 sec sustained; 5 = 60 sec sustained
Change in Child inhibition (verbal distraction) as assessed by score on Waiting Task
This task measures child frustration and parenting behaviors related to child's frustration. During this assessment the assessor provides the parent paperwork to complete and places an elaborately wrapped gift on the table in front of the child. The parent is instructed to have the child wait to open the gift until the assessor returns to the room and then the parent and child are left alone in a room for 8 minutes. Behavior is coded and scored.A score of 1 to 5 will be assigned to indicate how often the behavior occurred, as follows: 1 = did not happen; 2 = 1 brief instance; 3 = 2/3 times w/ sustaining behavior; 4 = 3/4 times w/ sustained behavior; 5 = spends most of minute trying to get parent attention in appropriate way
Change in Child inhibition (self-distraction) as assessed by score on Waiting Task
This task measures child frustration and parenting behaviors related to child's frustration. During this assessment the assessor provides the parent paperwork to complete and places an elaborately wrapped gift on the table in front of the child. The parent is instructed to have the child wait to open the gift until the assessor returns to the room and then the parent and child are left alone in a room for 8 minutes.Behavior is coded and scored A score of 1 to 5 will be assigned to indicate how often the behavior occurred, as follows: 1 = did not happen; 2 = 1 occurrence; 3 = 2/3 occurrences; 4 = 4 occurrences; 5 = 5 or more occurrences
Change in number of times parent exhibit warm sensitivity (physical soothing behaviors) as measured by the Waiting Task
This task measures child frustration and parenting behaviors related to child's frustration. During this assessment the assessor provides the parent paperwork to complete and places an elaborately wrapped gift on the table in front of the child. The parent is instructed to have the child wait to open the gift until the assessor returns to the room and then the parent and child are left alone in a room for 8 minutes. Number of times parent exhibits the behavior will be reported.
Change in number of times parent exhibits parental verbal scaffolding (verbal distraction behaviors) as measured by the Waiting Task
This task measures child frustration and parenting behaviors related to child's frustration. During this assessment the assessor provides the parent paperwork to complete and places an elaborately wrapped gift on the table in front of the child. The parent is instructed to have the child wait to open the gift until the assessor returns to the room and then the parent and child are left alone in a room for 8 minutes. Number of times parent exhibits the behavior will be reported.
Change in number of times parent exhibits parental contingent responsiveness (responsive behavior - promotion behaviors) as measured by the Waiting Task
This task measures child frustration and parenting behaviors related to child's frustration. During this assessment the assessor provides the parent paperwork to complete and places an elaborately wrapped gift on the table in front of the child. The parent is instructed to have the child wait to open the gift until the assessor returns to the room and then the parent and child are left alone in a room for 8 minutes. Number of times parent exhibits the behavior will be reported.
Change in Number of times parent exhibits non-responsive behavior(prevention behaviors) as measured by the Waiting Task
This task measures child frustration and parenting behaviors related to child's frustration. During this assessment the assessor provides the parent paperwork to complete and places an elaborately wrapped gift on the table in front of the child. The parent is instructed to have the child wait to open the gift until the assessor returns to the room and then the parent and child are left alone in a room for 8 minutes. Number of times parent exhibits the behavior will be reported.
Change in number of times parent exhibits parental non-responsive behavior(destructive coping and harsh physical restraint behaviors) as measured by the Waiting Task
This task measures child frustration and parenting behaviors related to child's frustration. During this assessment the assessor provides the parent paperwork to complete and places an elaborately wrapped gift on the table in front of the child. The parent is instructed to have the child wait to open the gift until the assessor returns to the room and then the parent and child are left alone in a room for 8 minutes. Number of times parent exhibits the behavior will be reported.
Change in Childs problem solving skill as measured by the Independent Toy Play task
This task measures child skill related to problem solving through goal-directed play. For this task, the child is videotaped while playing alone with five sequentially presented toys, each presented for 2mins. The video will be subsequently coded by dividing the play session into 10 second intervals. Level of the child's play is coded based on a hierarchical level-of-play scale ranging from 1 (off task) to 13 (goal-directed play with mastery).
Change in Child working memory as assessed by the 3-6-9 box task
This task measures child working memory. During the task, children are asked to search 3-, then 6-, then 9- box arrays for hidden rewards. Children are asked to search individual boxes in the array one at a time and to keep track of the boxes that were previously searched. Between each search attempt, the boxes are covered which requires children to remember which boxes were previously searched. The task begins with a 3-box array where children are given 10 trials to find three rewards. Children who complete the 3-box array will move on to a 6-box array where they will have 20 trials to locate six rewards. Children will only progress to the nine-box array (max. 30 trials) if the six-box array is completed in 14 trials or less. Score is reported as the number of rewards found divided by the number of total reaches.
Change in Child's self-restraint as assessed by score on the Gift Wrap step of the Gift Wrap/Waiting for Bow task
In this assessment, children are seated across a table from an assessor and are told that they will receive a present but that the present must be wrapped. The experimenter asks that the child turns their back and does not peek while she wraps the present because seeing it ruins the surprise. While the child is turned away, the experimenter noisily wraps for 1 minute. After this portion is complete, the experimenter tells the child that she forgot to put a bow on the gift, and asks the child to wait and not touch the box until she returns with a bow. The experimenter leaves for 2 minutes. Child's self-restraint is scored from 0-3 where 0 = no peeking, 1=Child looks over shoulder to peek, 2=child turns body in seat to peek, and 3 = child left her seat.
Change in Child's self-restraint as assessed by score on the Waiting for Bow step of the Gift Wrap/Waiting for Bow task
In this assessment, children are seated across a table from an assessor and are told that they will receive a present but that the present must be wrapped. The experimenter asks that the child turns their back and does not peek while she wraps the present because seeing it ruins the surprise. While the child is turned away, the experimenter noisily wraps for 1 minute. After this portion is complete, the experimenter tells the child that she forgot to put a bow on the gift, and asks the child to wait and not touch the box until she returns with a bow. The experimenter leaves for 2 minutes. Child's self-restraint is scored from 0-4 where 0 = no touching, 1 = child touches box, 2 = Child opens the box so that the lid is less than 2 inches from base; looks and then replaces lid, 3 = Child opens the box or child completely removes lid from box, and 4 = child removes the toy from the box or child touches the toy while it remains in the box.
Change in Child's distraction as assessed by score in the Waiting for Bow step of the Gift Wrap/Waiting for Bow task
In this assessment, children are seated across a table from an assessor and are told that they will receive a present but that the present must be wrapped. The experimenter asks that the child turns their back and does not peek while she wraps the present because seeing it ruins the surprise. While the child is turned away, the experimenter noisily wraps for 1 minute. After this portion is complete, the experimenter tells the child that she forgot to put a bow on the gift, and asks the child to wait and not touch the box until she returns with a bow. The experimenter leaves for 2 minutes. Child's distraction is scored from 0-5 where 1 = no active actions, 2 = a little bit of time, 3 = Some of the time, 4 = a lot of the time, 5 = most of the time.
Change in Noncompliance behaviors of child toward parent as measured by the Tool task
The parent and child complete two problem solving tasks that are graded in difficulty. The assessor explains the problem to the parent and gives the tool and apparatus to the child. The parent is instructed to allow the child to solve the problem independently, but provide as much help as they believe the child needs. Task 1 is the "tube task", in which the child has to insert a stick inside a tube to get a toy. Task 2 is the "clear box task" that requires the child to place a toy brick on a lever, which raises the lever to the top of the box, in which a toy becomes available. Only children who pass task 1 will go on to task 2. Noncompliance is scored from 1-6, and a higher score indicates greater non-compliance behaviors.
Change in anger behaviors of child as measured by the Tool task
The parent and child complete two problem solving tasks that are graded in difficulty. The assessor explains the problem to the parent and gives the tool and apparatus to the child. The parent is instructed to allow the child to solve the problem independently, but provide as much help as they believe the child needs. Task 1 is the "tube task", in which the child has to insert a stick inside a tube to get a toy. Task 2 is the "clear box task" that requires the child to place a toy brick on a lever, which raises the lever to the top of the box, in which a toy becomes available. Only children who pass task 1 will go on to task 2. Anger is scored form 1-6, with a higher score indicating greater anger behaviors.
Change in anger/frustration behaviors specifically directed to parent as measured by the Tool task
The parent and child complete two problem solving tasks that are graded in difficulty. The assessor explains the problem to the parent and gives the tool and apparatus to the child. The parent is instructed to allow the child to solve the problem independently, but provide as much help as they believe the child needs. Task 1 is the "tube task", in which the child has to insert a stick inside a tube to get a toy. Task 2 is the "clear box task" that requires the child to place a toy brick on a lever, which raises the lever to the top of the box, in which a toy becomes available. Only children who pass task 1 will go on to task 2. Anger/frustration behaviors specifically directed to parent is scored from 1-7, with a higher score indicating greater anger/frustration behaviors, .
Change in child coping as measured by the Tool task
The parent and child complete two problem solving tasks that are graded in difficulty. The assessor explains the problem to the parent and gives the tool and apparatus to the child. The parent is instructed to allow the child to solve the problem independently, but provide as much help as they believe the child needs. Task 1 is the "tube task", in which the child has to insert a stick inside a tube to get a toy. Task 2 is the "clear box task" that requires the child to place a toy brick on a lever, which raises the lever to the top of the box, in which a toy becomes available. Only children who pass task 1 will go on to task 2. Coping is scored 1-5, with a higher score indicating greater coping behaviors.
Change in Child enthusiasm for the task as measured by the Tool task
The parent and child complete two problem solving tasks that are graded in difficulty. The assessor explains the problem to the parent and gives the tool and apparatus to the child. The parent is instructed to allow the child to solve the problem independently, but provide as much help as they believe the child needs. Task 1 is the "tube task", in which the child has to insert a stick inside a tube to get a toy. Task 2 is the "clear box task" that requires the child to place a toy brick on a lever, which raises the lever to the top of the box, in which a toy becomes available. Only children who pass task 1 will go on to task 2. Enthusiasm is scored from 1-6, with a higher score indicating greater child enthusiasm for task.
Change in Child persistence behaviors related to attention as measured by the Tool task
The parent and child complete two problem solving tasks that are graded in difficulty. The assessor explains the problem to the parent and gives the tool and apparatus to the child. The parent is instructed to allow the child to solve the problem independently, but provide as much help as they believe the child needs. Task 1 is the "tube task", in which the child has to insert a stick inside a tube to get a toy. Task 2 is the "clear box task" that requires the child to place a toy brick on a lever, which raises the lever to the top of the box, in which a toy becomes available. Only children who pass task 1 will go on to task 2. Persistence related to attention is scored from 1-5, with a higher score indicating greater child persistence behaviors related to attention.
Change in children's developing abilities in early language as assessed by the MacArthur-Bates Communicative Development Inventories (MB-CDIs)
The MacArthur-Bates Communicative Development Inventories (MB-CDIs) are scored from 0 to 100 percentile, with a higher percentile indicating better language ability.
Change in Attention Disengagement to Positive and Negative Emotions as assessed by total time child looked at faces on screen during the looking task
Children will complete a looking task in which fearful, happy, neutral, and control faces are presented individually on a screen. After the looking task, the child will complete an overlap task with the same stimuli. First, child's attention will be directed to the center of the screen with an 'attention-getter'. After attention is fixated for 1 second, a face appears centered on the screen. After 1 second, a distractor image appears in the periphery either to the right or left and remains on the screen for 3 seconds.
Change in Attention Disengagement to Positive and Negative Emotions as assessed by longest individual time child looked at faces on screen during the looking task
Children will complete a looking task in which fearful, happy, neutral, and control faces are presented individually on a screen. After the looking task, the child will complete an overlap task with the same stimuli. First, child's attention will be directed to the center of the screen with an 'attention-getter'. After attention is fixated for 1 second, a face appears centered on the screen. After 1 second, a distractor image appears in the periphery either to the right or left and remains on the screen for 3 seconds.
Change in Attention Disengagement to Positive and Negative Emotions as assessed by the number of times child looked away from the faces and toward the distractor during the looking task
Children will complete a looking task in which fearful, happy, neutral, and control faces are presented individually on a screen. After the looking task, the child will complete an overlap task with the same stimuli. First, child's attention will be directed to the center of the screen with an 'attention-getter'. After attention is fixated for 1 second, a face appears centered on the screen. After 1 second, a distractor image appears in the periphery either to the right or left and remains on the screen for 3 seconds.
Change in White matter structural integrity as indicated by fractional anisotropy measured by diffusion tensor imaging (DTI) magnetic resonance imaging (MRI) - uncinate fasciculus tract
Anisotropy values range from 0 to 1, and a higher value indicates greater white matter structural integrity.
Change in White matter structural integrity as indicated by fractional anisotropy measured by diffusion tensor imaging (DTI) magnetic resonance imaging (MRI) - anterior thalamic radiation tract
Anisotropy values range from 0 to 1, and a higher value indicates greater white matter structural integrity.
Change in White matter structural integrity as indicated by fractional anisotropy measured by diffusion tensor imaging (DTI) magnetic resonance imaging (MRI) - cingulum tract
Anisotropy values range from 0 to 1, and a higher value indicates greater white matter structural integrity.
Change in White matter structural integrity as indicated by fractional anisotropy measured by diffusion tensor imaging (DTI) magnetic resonance imaging (MRI) - fornix tract
Anisotropy values range from 0 to 1, and a higher value indicates greater white matter structural integrity.
Change in functional activity during rest as indicated by Resting Electroencephalography (EEG) value
Following application of EEG caps and electrodes, resting EEG will be collected for 5 minute while an experimenter blows bubbles.
Change in functional activity when engaged in sustained activity as indicated by Event-related potential (ERP) negative central (NC) value recorded during EEG
For ERP assessment, children view emotional faces in a passive viewing paradigm on a computer screen while EEG is performed.
Change in functional activity when engaged in sustained activity as indicated by Event-related potential (ERP) positive slow wave (PSW) value recorded during EEG
For ERP assessment, children view emotional faces in a passive viewing paradigm on a computer screen while EEG is performed.
Secondary Outcome Measures
Maternal depression as measured by the Beck's Depression Inventory
This 21-item multiple-choice self-report inventory. Total score ranges from 0-63 a higher number indicating greater depression.
Degree of chaos in the home as measured by the CHAOS questionnaire
The questionnaire includes 15 forced-choice items. Total score ranges from 15-90. A higher total score will indicate a home environment that is more chaotic
COVID-19 Exposure and Family Impact as assessed by the COVID-19 Exposure and Family Impact Survey - Exposure Score
This survey will measure family exposure to potentially traumatic aspects of COVID-19 and assesses the impact of the pandemic on the family. Parents will complete the survey. The Exposure Score ranges from 0 to 25, with a higher score indicating greater exposure.
COVID-19 Exposure and Family Impact as assessed by the COVID-19 Exposure and Family Impact Survey - Impact Score
This survey will measure family exposure to potentially traumatic aspects of COVID-19 and assesses the impact of the pandemic on the family. Parents will complete the survey. The Impact Score ranges from 12 to 60, with a higher score indicating greater impact.
Full Information
NCT ID
NCT04856501
First Posted
April 19, 2021
Last Updated
September 3, 2021
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Herman H. Fleishman Foundation, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT04856501
Brief Title
A Randomized Control Trial of a Responsive Parenting Intervention to Support Healthy Brain Development and Self-regulation in Toddlers Born Preterm
Official Title
A Randomized Control Trial of a Responsive Parenting Intervention to Support Healthy Brain Development and Self-regulation in Toddlers Born Preterm
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Recruiting
Study Start Date
August 7, 2020 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Herman H. Fleishman Foundation, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether participation in the Play and Learning Strategies (PALS) parenting intervention results in increased caregiver responsiveness behaviors and to test if participation in PALS results in increases in toddler skills and/or toddler neurological development.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Birth
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PALS intervention condition
Arm Type
Experimental
Arm Title
Control condition
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
PALS intervention condition
Intervention Description
The Play and Learning Strategies (PALS) intervention provides parents with behaviors that, collectively, are known as a responsive parenting style. Four constructs make up this responsive parenting style: 1) contingent responsiveness, (responses are conditionally linked to the child's signals) 2) warm sensitivity (high levels of affection and understanding of child states), 3) maintaining vs. redirecting attention, and 4) verbal scaffolding (providing child appropriate language supports). Parents assigned to this intervention will be paired with a coach who will guide them through the program over the course of 9 weekly sessions. The intervention (ePALS) will be implemented via an internet adaptation through the Children's Learning Institute's ENGAGE platform. However, ePALS could easily be adapted for other platforms and accessed with any web-enabled device.
Intervention Type
Behavioral
Intervention Name(s)
Control condition
Intervention Description
Families assigned to the control condition will be provided with a website with information corresponding to milestones of toddler development. Control families will be asked to review that week's materials before the each of the 9 weekly coach calls. The active control condition serves three important purposes: 1) Maintains an active line of communication and accurate contact records for Post-test 1 and Post-test 2 session scheduling; 2) Masks participant's awareness of intervention vs. control assignment; and 3) Approximates communication with intervention staff such that results showing ePALS effects are attributable to intervention rather than regular communication with an interventionist.
Primary Outcome Measure Information:
Title
Change in Parental contingent responsiveness as measured by the Parent-child Toy Play Observation
Description
In this task the child will interact with their parent in a "free play" task for 10 minutes with a set of standardized toys, and the interaction will be videotaped. Parents are asked to play with their children in "typical ways" with a few constraints (e.g., television must be off). Behavior will be coded and assigned a score of how of 1-5 which indicates how often the assessed behavior occurs: 5 (Almost Always); 4 (greater than half the time); 3 (half the time); 2 (less than half the time); 1 (None of the time).
Time Frame
Baseline, Post-test 1 (1-2 weeks after intervention)
Title
Change in Parental warm sensitivity (display of positive affect) as measured by the Parent-child Toy Play Observation
Description
In this task the child will interact with their parent in a "free play" task for 10 minutes with a set of standardized toys, and the interaction will be videotaped. Parents are asked to play with their children in "typical ways" with a few constraints (e.g., television must be off). Behavior will be coded and assigned a score of how of 1-5 which indicates how often the assessed behavior occurs: 5 (Almost Always); 4 (greater than half the time); 3 (half the time); 2 (less than half the time); 1 (None of the time).
Time Frame
Baseline, Post-test 1 (1-2 weeks after intervention)
Title
Change in Parental warm sensitivity (warmth) as measured by the Parent-child Toy Play Observation
Description
In this task the child will interact with their parent in a "free play" task for 10 minutes with a set of standardized toys, and the interaction will be videotaped. Parents are asked to play with their children in "typical ways" with a few constraints (e.g., television must be off). Behavior will be coded and assigned a score of how of 1-5 which indicates how often the assessed behavior occurs: 5 (Almost Always); 4 (greater than half the time); 3 (half the time); 2 (less than half the time); 1 (None of the time).
Time Frame
Baseline, Post-test 1 (1-2 weeks after intervention)
Title
Change in Parental maintaining of child's signals and interests as measured by the Parent-child Toy Play Observation
Description
In this task the child will interact with their parent in a "free play" task for 10 minutes with a set of standardized toys, and the interaction will be videotaped. Parents are asked to play with their children in "typical ways" with a few constraints (e.g., television must be off). Behavior will be coded and assigned a score of how of 1-5 which indicates how often the assessed behavior occurs: 5 (Almost Always); 4 (greater than half the time); 3 (half the time); 2 (less than half the time); 1 (None of the time).
Time Frame
Baseline, Post-test 1 (1-2 weeks after intervention)
Title
Change in Parental verbal scaffolding as measured by the Parent-child Toy Play Observation
Description
In this task the child will interact with their parent in a "free play" task for 10 minutes with a set of standardized toys, and the interaction will be videotaped. Parents are asked to play with their children in "typical ways" with a few constraints (e.g., television must be off). Behavior will be coded and assigned a score of how of 1-5 which indicates how often the assessed behavior occurs: 5 (Almost Always); 4 (greater than half the time); 3 (half the time); 2 (less than half the time); 1 (None of the time).
Time Frame
Baseline, Post-test 1 (1-2 weeks after intervention)
Title
Change in Child attentional engagement (engagement with environment) as measured by the Parent-child Toy Play Observation
Description
In this task the child will interact with their parent in a "free play" task for 10 minutes with a set of standardized toys, and the interaction will be videotaped. Parents are asked to play with their children in "typical ways" with a few constraints (e.g., television must be off). Behavior will be coded and assigned a score of how of 1-5 which indicates how often the assessed behavior occurs: 5 (Almost Always); 4 (greater than half the time); 3 (half the time); 2 (less than half the time); 1 (None of the time).
Time Frame
Baseline, Post-test 1 (1-2 weeks after intervention)
Title
Change in Child attentional engagement (social engagement) as measured by the Parent-child Toy Play Observation
Description
In this task the child will interact with their parent in a "free play" task for 10 minutes with a set of standardized toys, and the interaction will be videotaped. Parents are asked to play with their children in "typical ways" with a few constraints (e.g., television must be off). Behavior will be coded and assigned a score of how of 1-5 which indicates how often the assessed behavior occurs: 5 (Almost Always); 4 (greater than half the time); 3 (half the time); 2 (less than half the time); 1 (None of the time).
Time Frame
Baseline, Post-test 1 (1-2 weeks after intervention)
Title
Change in Child emotional regulation as measured by the Parent-child Toy Play Observation
Description
In this task the child will interact with their parent in a "free play" task for 10 minutes with a set of standardized toys, and the interaction will be videotaped. Parents are asked to play with their children in "typical ways" with a few constraints (e.g., television must be off). Behavior will be coded and assigned a score of how of 1-5 which indicates how often the assessed behavior occurs: 5 (Almost Always); 4 (greater than half the time); 3 (half the time); 2 (less than half the time); 1 (None of the time).
Time Frame
Baseline, Post-test 1 (1-2 weeks after intervention)
Title
Change in Child cooperation as measured by the Parent-child Toy Play Observation
Description
In this task the child will interact with their parent in a "free play" task for 10 minutes with a set of standardized toys, and the interaction will be videotaped. Parents are asked to play with their children in "typical ways" with a few constraints (e.g., television must be off). Behavior will be coded and assigned a score of how of 1-5 which indicates how often the assessed behavior occurs: 5 (Almost Always); 4 (greater than half the time); 3 (half the time); 2 (less than half the time); 1 (None of the time).
Time Frame
Baseline, Post-test 1 (1-2 weeks after intervention)
Title
Change in Child emotional regulation (proximity seeking behaviors) as assessed by score on Waiting Task
Description
This task measures child frustration and parenting behaviors related to child's frustration. During this assessment the assessor provides the parent paperwork to complete and places an elaborately wrapped gift on the table in front of the child. The parent is instructed to have the child wait to open the gift until the assessor returns to the room and then the parent and child are left alone in a room for 8 minutes. Behavior is coded and scored.A score of 1 to 5 will be assigned to indicate how often the behavior occurred, as follows: 1 = 0 reaches; 2 = 1 - 2 reaches that are 15sec. sustained; 3 = 3 reaches that are 30sec. sustained; 4 = 4 Individually scored reaches that are 45sec. sustained; 5 = 5 or more reaches that are 60sec.
Time Frame
Baseline, Post-test 1 (1-2 weeks after intervention)
Title
Change in Child emotional regulation (venting/aggression/distress behaviors) as assessed by score on Waiting Task
Description
This task measures child frustration and parenting behaviors related to child's frustration. During this assessment the assessor provides the parent paperwork to complete and places an elaborately wrapped gift on the table in front of the child. The parent is instructed to have the child wait to open the gift until the assessor returns to the room and then the parent and child are left alone in a room for 8 minutes. Behavior is coded and scored. A score of 1 to 5 will be assigned to indicate how often the behavior occurred, as follows: 1 = did not happen; 2 = 1 brief instance -15 sec. sustained; 3 = 2 - 3 times -30 sec. sustained; 4 = ¾ instances - 45 sec. sustained; 5 = spends most of minute - >45 sec.
Time Frame
Baseline, Post-test 1 (1-2 weeks after intervention)
Title
Change in Child emotional regulation (disengaged behavior) as assessed by score on Waiting Task
Description
This task measures child frustration and parenting behaviors related to child's frustration. During this assessment the assessor provides the parent paperwork to complete and places an elaborately wrapped gift on the table in front of the child. The parent is instructed to have the child wait to open the gift until the assessor returns to the room and then the parent and child are left alone in a room for 8 minutes. Behavior is coded and scored. A score of 1 to 5 will be assigned to indicate how often the behavior occurred, as follows: 1 = 0 sec.; 2 = 15 sec. sustained; 3 = 30 sec sustained; 4 = 45 sec sustained; 5 = 60 sec sustained
Time Frame
Baseline, Post-test 1 (1-2 weeks after intervention)
Title
Change in Child inhibition (verbal distraction) as assessed by score on Waiting Task
Description
This task measures child frustration and parenting behaviors related to child's frustration. During this assessment the assessor provides the parent paperwork to complete and places an elaborately wrapped gift on the table in front of the child. The parent is instructed to have the child wait to open the gift until the assessor returns to the room and then the parent and child are left alone in a room for 8 minutes. Behavior is coded and scored.A score of 1 to 5 will be assigned to indicate how often the behavior occurred, as follows: 1 = did not happen; 2 = 1 brief instance; 3 = 2/3 times w/ sustaining behavior; 4 = 3/4 times w/ sustained behavior; 5 = spends most of minute trying to get parent attention in appropriate way
Time Frame
Baseline, Post-test 1 (1-2 weeks after intervention)
Title
Change in Child inhibition (self-distraction) as assessed by score on Waiting Task
Description
This task measures child frustration and parenting behaviors related to child's frustration. During this assessment the assessor provides the parent paperwork to complete and places an elaborately wrapped gift on the table in front of the child. The parent is instructed to have the child wait to open the gift until the assessor returns to the room and then the parent and child are left alone in a room for 8 minutes.Behavior is coded and scored A score of 1 to 5 will be assigned to indicate how often the behavior occurred, as follows: 1 = did not happen; 2 = 1 occurrence; 3 = 2/3 occurrences; 4 = 4 occurrences; 5 = 5 or more occurrences
Time Frame
Baseline, Post-test 1 (1-2 weeks after intervention)
Title
Change in number of times parent exhibit warm sensitivity (physical soothing behaviors) as measured by the Waiting Task
Description
This task measures child frustration and parenting behaviors related to child's frustration. During this assessment the assessor provides the parent paperwork to complete and places an elaborately wrapped gift on the table in front of the child. The parent is instructed to have the child wait to open the gift until the assessor returns to the room and then the parent and child are left alone in a room for 8 minutes. Number of times parent exhibits the behavior will be reported.
Time Frame
Baseline, Post-test 1 (1-2 weeks after intervention)
Title
Change in number of times parent exhibits parental verbal scaffolding (verbal distraction behaviors) as measured by the Waiting Task
Description
This task measures child frustration and parenting behaviors related to child's frustration. During this assessment the assessor provides the parent paperwork to complete and places an elaborately wrapped gift on the table in front of the child. The parent is instructed to have the child wait to open the gift until the assessor returns to the room and then the parent and child are left alone in a room for 8 minutes. Number of times parent exhibits the behavior will be reported.
Time Frame
Baseline, Post-test 1 (1-2 weeks after intervention)
Title
Change in number of times parent exhibits parental contingent responsiveness (responsive behavior - promotion behaviors) as measured by the Waiting Task
Description
This task measures child frustration and parenting behaviors related to child's frustration. During this assessment the assessor provides the parent paperwork to complete and places an elaborately wrapped gift on the table in front of the child. The parent is instructed to have the child wait to open the gift until the assessor returns to the room and then the parent and child are left alone in a room for 8 minutes. Number of times parent exhibits the behavior will be reported.
Time Frame
Baseline, Post-test 1 (1-2 weeks after intervention)
Title
Change in Number of times parent exhibits non-responsive behavior(prevention behaviors) as measured by the Waiting Task
Description
This task measures child frustration and parenting behaviors related to child's frustration. During this assessment the assessor provides the parent paperwork to complete and places an elaborately wrapped gift on the table in front of the child. The parent is instructed to have the child wait to open the gift until the assessor returns to the room and then the parent and child are left alone in a room for 8 minutes. Number of times parent exhibits the behavior will be reported.
Time Frame
Baseline, Post-test 1 (1-2 weeks after intervention)
Title
Change in number of times parent exhibits parental non-responsive behavior(destructive coping and harsh physical restraint behaviors) as measured by the Waiting Task
Description
This task measures child frustration and parenting behaviors related to child's frustration. During this assessment the assessor provides the parent paperwork to complete and places an elaborately wrapped gift on the table in front of the child. The parent is instructed to have the child wait to open the gift until the assessor returns to the room and then the parent and child are left alone in a room for 8 minutes. Number of times parent exhibits the behavior will be reported.
Time Frame
Baseline, Post-test 1 (1-2 weeks after intervention)
Title
Change in Childs problem solving skill as measured by the Independent Toy Play task
Description
This task measures child skill related to problem solving through goal-directed play. For this task, the child is videotaped while playing alone with five sequentially presented toys, each presented for 2mins. The video will be subsequently coded by dividing the play session into 10 second intervals. Level of the child's play is coded based on a hierarchical level-of-play scale ranging from 1 (off task) to 13 (goal-directed play with mastery).
Time Frame
Baseline, Post-test-2 (4 months after post test1)
Title
Change in Child working memory as assessed by the 3-6-9 box task
Description
This task measures child working memory. During the task, children are asked to search 3-, then 6-, then 9- box arrays for hidden rewards. Children are asked to search individual boxes in the array one at a time and to keep track of the boxes that were previously searched. Between each search attempt, the boxes are covered which requires children to remember which boxes were previously searched. The task begins with a 3-box array where children are given 10 trials to find three rewards. Children who complete the 3-box array will move on to a 6-box array where they will have 20 trials to locate six rewards. Children will only progress to the nine-box array (max. 30 trials) if the six-box array is completed in 14 trials or less. Score is reported as the number of rewards found divided by the number of total reaches.
Time Frame
Baseline, Post-test-2 (4 months after post test1)
Title
Change in Child's self-restraint as assessed by score on the Gift Wrap step of the Gift Wrap/Waiting for Bow task
Description
In this assessment, children are seated across a table from an assessor and are told that they will receive a present but that the present must be wrapped. The experimenter asks that the child turns their back and does not peek while she wraps the present because seeing it ruins the surprise. While the child is turned away, the experimenter noisily wraps for 1 minute. After this portion is complete, the experimenter tells the child that she forgot to put a bow on the gift, and asks the child to wait and not touch the box until she returns with a bow. The experimenter leaves for 2 minutes. Child's self-restraint is scored from 0-3 where 0 = no peeking, 1=Child looks over shoulder to peek, 2=child turns body in seat to peek, and 3 = child left her seat.
Time Frame
Baseline, Post-test-2 (4 months after post test1)
Title
Change in Child's self-restraint as assessed by score on the Waiting for Bow step of the Gift Wrap/Waiting for Bow task
Description
In this assessment, children are seated across a table from an assessor and are told that they will receive a present but that the present must be wrapped. The experimenter asks that the child turns their back and does not peek while she wraps the present because seeing it ruins the surprise. While the child is turned away, the experimenter noisily wraps for 1 minute. After this portion is complete, the experimenter tells the child that she forgot to put a bow on the gift, and asks the child to wait and not touch the box until she returns with a bow. The experimenter leaves for 2 minutes. Child's self-restraint is scored from 0-4 where 0 = no touching, 1 = child touches box, 2 = Child opens the box so that the lid is less than 2 inches from base; looks and then replaces lid, 3 = Child opens the box or child completely removes lid from box, and 4 = child removes the toy from the box or child touches the toy while it remains in the box.
Time Frame
Baseline, Post-test-2 (4 months after post test1)
Title
Change in Child's distraction as assessed by score in the Waiting for Bow step of the Gift Wrap/Waiting for Bow task
Description
In this assessment, children are seated across a table from an assessor and are told that they will receive a present but that the present must be wrapped. The experimenter asks that the child turns their back and does not peek while she wraps the present because seeing it ruins the surprise. While the child is turned away, the experimenter noisily wraps for 1 minute. After this portion is complete, the experimenter tells the child that she forgot to put a bow on the gift, and asks the child to wait and not touch the box until she returns with a bow. The experimenter leaves for 2 minutes. Child's distraction is scored from 0-5 where 1 = no active actions, 2 = a little bit of time, 3 = Some of the time, 4 = a lot of the time, 5 = most of the time.
Time Frame
Baseline, Post-test-2 (4 months after post test1)
Title
Change in Noncompliance behaviors of child toward parent as measured by the Tool task
Description
The parent and child complete two problem solving tasks that are graded in difficulty. The assessor explains the problem to the parent and gives the tool and apparatus to the child. The parent is instructed to allow the child to solve the problem independently, but provide as much help as they believe the child needs. Task 1 is the "tube task", in which the child has to insert a stick inside a tube to get a toy. Task 2 is the "clear box task" that requires the child to place a toy brick on a lever, which raises the lever to the top of the box, in which a toy becomes available. Only children who pass task 1 will go on to task 2. Noncompliance is scored from 1-6, and a higher score indicates greater non-compliance behaviors.
Time Frame
Baseline, Post-test-2 (4 months after post test1)
Title
Change in anger behaviors of child as measured by the Tool task
Description
The parent and child complete two problem solving tasks that are graded in difficulty. The assessor explains the problem to the parent and gives the tool and apparatus to the child. The parent is instructed to allow the child to solve the problem independently, but provide as much help as they believe the child needs. Task 1 is the "tube task", in which the child has to insert a stick inside a tube to get a toy. Task 2 is the "clear box task" that requires the child to place a toy brick on a lever, which raises the lever to the top of the box, in which a toy becomes available. Only children who pass task 1 will go on to task 2. Anger is scored form 1-6, with a higher score indicating greater anger behaviors.
Time Frame
Baseline, Post-test-2 (4 months after post test1)
Title
Change in anger/frustration behaviors specifically directed to parent as measured by the Tool task
Description
The parent and child complete two problem solving tasks that are graded in difficulty. The assessor explains the problem to the parent and gives the tool and apparatus to the child. The parent is instructed to allow the child to solve the problem independently, but provide as much help as they believe the child needs. Task 1 is the "tube task", in which the child has to insert a stick inside a tube to get a toy. Task 2 is the "clear box task" that requires the child to place a toy brick on a lever, which raises the lever to the top of the box, in which a toy becomes available. Only children who pass task 1 will go on to task 2. Anger/frustration behaviors specifically directed to parent is scored from 1-7, with a higher score indicating greater anger/frustration behaviors, .
Time Frame
Baseline, Post-test-2 (4 months after post test1)
Title
Change in child coping as measured by the Tool task
Description
The parent and child complete two problem solving tasks that are graded in difficulty. The assessor explains the problem to the parent and gives the tool and apparatus to the child. The parent is instructed to allow the child to solve the problem independently, but provide as much help as they believe the child needs. Task 1 is the "tube task", in which the child has to insert a stick inside a tube to get a toy. Task 2 is the "clear box task" that requires the child to place a toy brick on a lever, which raises the lever to the top of the box, in which a toy becomes available. Only children who pass task 1 will go on to task 2. Coping is scored 1-5, with a higher score indicating greater coping behaviors.
Time Frame
Baseline, Post-test-2 (4 months after post test1)
Title
Change in Child enthusiasm for the task as measured by the Tool task
Description
The parent and child complete two problem solving tasks that are graded in difficulty. The assessor explains the problem to the parent and gives the tool and apparatus to the child. The parent is instructed to allow the child to solve the problem independently, but provide as much help as they believe the child needs. Task 1 is the "tube task", in which the child has to insert a stick inside a tube to get a toy. Task 2 is the "clear box task" that requires the child to place a toy brick on a lever, which raises the lever to the top of the box, in which a toy becomes available. Only children who pass task 1 will go on to task 2. Enthusiasm is scored from 1-6, with a higher score indicating greater child enthusiasm for task.
Time Frame
Baseline, Post-test-2 (4 months after post test1)
Title
Change in Child persistence behaviors related to attention as measured by the Tool task
Description
The parent and child complete two problem solving tasks that are graded in difficulty. The assessor explains the problem to the parent and gives the tool and apparatus to the child. The parent is instructed to allow the child to solve the problem independently, but provide as much help as they believe the child needs. Task 1 is the "tube task", in which the child has to insert a stick inside a tube to get a toy. Task 2 is the "clear box task" that requires the child to place a toy brick on a lever, which raises the lever to the top of the box, in which a toy becomes available. Only children who pass task 1 will go on to task 2. Persistence related to attention is scored from 1-5, with a higher score indicating greater child persistence behaviors related to attention.
Time Frame
Baseline, Post-test-2 (4 months after post test1)
Title
Change in children's developing abilities in early language as assessed by the MacArthur-Bates Communicative Development Inventories (MB-CDIs)
Description
The MacArthur-Bates Communicative Development Inventories (MB-CDIs) are scored from 0 to 100 percentile, with a higher percentile indicating better language ability.
Time Frame
Baseline, Post-test 2 (4 months after post test1)
Title
Change in Attention Disengagement to Positive and Negative Emotions as assessed by total time child looked at faces on screen during the looking task
Description
Children will complete a looking task in which fearful, happy, neutral, and control faces are presented individually on a screen. After the looking task, the child will complete an overlap task with the same stimuli. First, child's attention will be directed to the center of the screen with an 'attention-getter'. After attention is fixated for 1 second, a face appears centered on the screen. After 1 second, a distractor image appears in the periphery either to the right or left and remains on the screen for 3 seconds.
Time Frame
Baseline, Post-test 2 (4 months after post test1)
Title
Change in Attention Disengagement to Positive and Negative Emotions as assessed by longest individual time child looked at faces on screen during the looking task
Description
Children will complete a looking task in which fearful, happy, neutral, and control faces are presented individually on a screen. After the looking task, the child will complete an overlap task with the same stimuli. First, child's attention will be directed to the center of the screen with an 'attention-getter'. After attention is fixated for 1 second, a face appears centered on the screen. After 1 second, a distractor image appears in the periphery either to the right or left and remains on the screen for 3 seconds.
Time Frame
Baseline, Post-test 2 (4 months after post test1)
Title
Change in Attention Disengagement to Positive and Negative Emotions as assessed by the number of times child looked away from the faces and toward the distractor during the looking task
Description
Children will complete a looking task in which fearful, happy, neutral, and control faces are presented individually on a screen. After the looking task, the child will complete an overlap task with the same stimuli. First, child's attention will be directed to the center of the screen with an 'attention-getter'. After attention is fixated for 1 second, a face appears centered on the screen. After 1 second, a distractor image appears in the periphery either to the right or left and remains on the screen for 3 seconds.
Time Frame
Baseline, Post-test 2 (4 months after post test1)
Title
Change in White matter structural integrity as indicated by fractional anisotropy measured by diffusion tensor imaging (DTI) magnetic resonance imaging (MRI) - uncinate fasciculus tract
Description
Anisotropy values range from 0 to 1, and a higher value indicates greater white matter structural integrity.
Time Frame
Baseline, Post-test 2 (4 months after post test1)
Title
Change in White matter structural integrity as indicated by fractional anisotropy measured by diffusion tensor imaging (DTI) magnetic resonance imaging (MRI) - anterior thalamic radiation tract
Description
Anisotropy values range from 0 to 1, and a higher value indicates greater white matter structural integrity.
Time Frame
Baseline, Post-test 2 (4 months after post test1)
Title
Change in White matter structural integrity as indicated by fractional anisotropy measured by diffusion tensor imaging (DTI) magnetic resonance imaging (MRI) - cingulum tract
Description
Anisotropy values range from 0 to 1, and a higher value indicates greater white matter structural integrity.
Time Frame
Baseline, Post-test 2 (4 months after post test1)
Title
Change in White matter structural integrity as indicated by fractional anisotropy measured by diffusion tensor imaging (DTI) magnetic resonance imaging (MRI) - fornix tract
Description
Anisotropy values range from 0 to 1, and a higher value indicates greater white matter structural integrity.
Time Frame
Baseline, Post-test 2 (4 months after post test1)
Title
Change in functional activity during rest as indicated by Resting Electroencephalography (EEG) value
Description
Following application of EEG caps and electrodes, resting EEG will be collected for 5 minute while an experimenter blows bubbles.
Time Frame
Baseline, Post-test 2 (4 months after post test1)
Title
Change in functional activity when engaged in sustained activity as indicated by Event-related potential (ERP) negative central (NC) value recorded during EEG
Description
For ERP assessment, children view emotional faces in a passive viewing paradigm on a computer screen while EEG is performed.
Time Frame
Baseline, Post-test 2 (4 months after post test1)
Title
Change in functional activity when engaged in sustained activity as indicated by Event-related potential (ERP) positive slow wave (PSW) value recorded during EEG
Description
For ERP assessment, children view emotional faces in a passive viewing paradigm on a computer screen while EEG is performed.
Time Frame
Baseline, Post-test 2 (4 months after post test1)
Secondary Outcome Measure Information:
Title
Maternal depression as measured by the Beck's Depression Inventory
Description
This 21-item multiple-choice self-report inventory. Total score ranges from 0-63 a higher number indicating greater depression.
Time Frame
Post-test 1 (1-2 weeks post intervention)
Title
Degree of chaos in the home as measured by the CHAOS questionnaire
Description
The questionnaire includes 15 forced-choice items. Total score ranges from 15-90. A higher total score will indicate a home environment that is more chaotic
Time Frame
Post-test 1 (1-2 weeks post intervention)
Title
COVID-19 Exposure and Family Impact as assessed by the COVID-19 Exposure and Family Impact Survey - Exposure Score
Description
This survey will measure family exposure to potentially traumatic aspects of COVID-19 and assesses the impact of the pandemic on the family. Parents will complete the survey. The Exposure Score ranges from 0 to 25, with a higher score indicating greater exposure.
Time Frame
Post-test 1 (1-2 weeks post intervention)
Title
COVID-19 Exposure and Family Impact as assessed by the COVID-19 Exposure and Family Impact Survey - Impact Score
Description
This survey will measure family exposure to potentially traumatic aspects of COVID-19 and assesses the impact of the pandemic on the family. Parents will complete the survey. The Impact Score ranges from 12 to 60, with a higher score indicating greater impact.
Time Frame
Post-test 1 (1-2 weeks post intervention)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Months
Maximum Age & Unit of Time
30 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- Maternal age over 18-years when child was born
Exclusion Criteria:
presence of known/suspected congenital anomalies including chromosomal or complex congenital heart disease
congenital infection including TORCH (Toxoplasmosis, Rubella, Cytomegalovirus, Herpes Simplex and others),untreated maternal HIV, or maternal syphilis
bilateral grade 3/4 intraventricular hemorrhage,intraparenchymal hemorrhage, hydrocephalus
Cerebral palsy with Gross Motor Function Classification of III or higher
blindness-
deafness
Current maternal drug use or maternal drug use during pregnancy
families who reside outside the catchment area (>1 hour drive from the Texas Medical Center)
Child with contraindication for MRI. If the mother of the child is pregnant, thinks she might be pregnant, or has a contraindication for MRI, another relative of the child will be asked to assist with the MRIs
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dana DeMaster, PhD
Phone
(713) 500-8315
Email
Dana.M.DeMaster@uth.tmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kelly Vaughn
Phone
713-500-8243
Email
Kelly.A.Vaughn@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dana DeMaster, PhD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dana DeMaster, PhD
Phone
713-500-8315
Email
Dana.M.DeMaster@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Kelly Vaughn
Phone
713-500-8243
Email
Kelly.A.Vaughn@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Susan Landry
First Name & Middle Initial & Last Name & Degree
Johanna Bick
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Randomized Control Trial of a Responsive Parenting Intervention to Support Healthy Brain Development and Self-regulation in Toddlers Born Preterm
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