Intervening Early: Key Adolescent Outcomes (SCOH-A)
Primary Purpose
Depressive Symptoms, Conduct Disorder, Anxiety Disorders
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Attachment and Biobehavioral Catch-up (ABC)
Developmental Education for Families (DEF)
Sponsored by
About this trial
This is an interventional prevention trial for Depressive Symptoms
Eligibility Criteria
Inclusion Criteria:
- Must have been included in middle childhood data collection
Exclusion Criteria:
- None
Sites / Locations
- University of Delaware
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Attachment and Biobehavioral Catch-up (ABC)
Developmental Education for Families (DEF)
Arm Description
10 sessions that focused on parental nurturance, and sensitivity
10 sessions that focused on cognitive development
Outcomes
Primary Outcome Measures
Brain activation in Stop Signal Task
Prefrontal cortex activation assessed through functional magnetic resonance imaging (fMRI) in task requiring inhibitory control
Brain activation in Mother-Stranger Task
Functional connectivity assessed through fMRI when viewing photos of mothers vs. strangers
Brain activation in Mother-Stranger Task
Functional connectivity assessed through fMRI when viewing photos of mothers vs. strangers
Brain activation in Emotion Go/Nogo task
Functional connectivity between amygdala and PFC assessed through fMRI in an emotion go/no go task
Brain activation in Emotional Reappraisal Task
Functional connectivity between amygdala and PFC assessed through fMRI in emotional reappraisal task
Brain activation in Emotion Go/Nogo task
Functional connectivity between amygdala and PFC assessed through fMRI in an emotion go/no go task
Trier Social Stress Test- Cortisol
Participants will be met by two research assistants (one male, one female), whom they have not met previously. The research assistants will tell the participants that they will have 5 minutes to prepare a speech which they will give to the researchers who will rate the speech. Participants will then give their speeches for 5 minutes; the research assistants will maintain neutral expressions and provide no feedback. Afterwards, participants will be asked to do (age-adjusted) mental arithmetic aloud (Buske-Kirschbaum et al.,1997). For the purpose of assessing cortisol, investigators will collect saliva samples before and after the speech/math.
Trier Social Stress Test-ANS
Participants will be met by two research assistants (one male, one female), whom they have not met previously. The research assistants will tell the participants that they will have 5 minutes to prepare a speech which they will give to the researchers who will rate the speech. Participants will then give their speeches for 5 minutes; the research assistants will maintain neutral expressions and provide no feedback. Afterwards, participants will be asked to do (age-adjusted) mental arithmetic aloud (Buske-Kirschbaum et al.,1997).Assess child autonomic nervous system regulation, examine reactivity from baseline in RSA.
Revealed differences task - parent sensitivity.
Parents and children engage in conflict discussion. Assess parental sensitivity using Sensitivity scale. Parental behavior is scored on a 1-7 scale, with higher scores reflecting greater sensitivity.
Support task- parent sensitivity
Parents and children engage in support discussion (discussing Trier task from previous year). Assess parental sensitivity using Sensitivity scale. Parental behavior is scored on a 1-7 scale, with higher scores reflecting greater sensitivity.
Revealed differences task- parent sensitivity
Parents and children engage in conflict discussion. Assess parental sensitivity using Sensitivity scale. Parental behavior is scored on a 1-7 scale, with higher scores reflecting greater sensitivity.
Revealed differences task-adolescent competence
Parents and children engage in conflict discussion. Assess child competence in discussion on Competence scale. Competence is scored on a 1-7 scale, with higher scores reflecting greater competence.
Support task-adolescent competence
Parents and children engage in conflict discussion. Assess child competence in discussion on Competence scale. Competence is scored on a 1-7 scale, with higher scores reflecting greater competence.
Revealed differences task-adolescent competence
Parents and children engage in conflict discussion. Assess child competence in discussion on Competence scale. Competence is scored on a 1-7 scale, with higher scores reflecting greater competence.
Revealed differences task-adolescent ANS
The control of cardiac functions via the vagal nerve, or vagal tone, is an index of parasympathetic activity. It can be measured by heart rate variability associated with respiration or high frequency respiratory sinus arrhythmia (RSA). RSA data will be collected continuously throughout the parent-child interaction using a MindWare Portable Lab system. Greater changes in RSA from baseline to discussion considered preferable.
Parents and children engage in conflict discussion. Assess child autonomic nervous system regulation. Respiratory sinus arrhythmia (RSA) will be measured as a rise from baseline.
Support task-adolescent ANS
The control of cardiac functions via the vagal nerve, or vagal tone, is an index of parasympathetic activity. It can be measured by heart rate variability associated with respiration or high frequency respiratory sinus arrhythmia (RSA). RSA data will be collected continuously throughout the parent-child interaction using a MindWare Portable Lab system. Greater changes in RSA from baseline to discussion considered preferable.
Revealed differences task-adolescent ANS
The control of cardiac functions via the vagal nerve, or vagal tone, is an index of parasympathetic activity. It can be measured by heart rate variability associated with respiration or high frequency respiratory sinus arrhythmia (RSA). RSA data will be collected continuously throughout the parent-child interaction using a MindWare Portable Lab system. Greater changes in RSA from baseline to discussion considered preferable.
Balloon Analogue Risk Task (BART)
This task assesses risk-taking through a computer game in which participants see a balloon on the computer screen and have the option of pumping up the balloon more, and therefore increasing its monetary value, or stopping and collecting the value of the balloon. If the balloon pops on a pump, then all of the value of the balloon is lost and the next trial begins. There is a randomly, pre-determined probability of the balloon popping on any given pump of each trial. A brief version of the task with 15 balloons will be used. A running tally of participants' total monetary gain is kept (and can range from $0 up to a cap of $5). The amount of money earned is the score, with more money reflecting higher risk taking.
Delay Discounting
Delay Discounting Task is a brief, five-item task on a computer that asks participants their preference between $5 now and $10 at some later time point (Koffarnus, Warren, & Bickel, 2014). No money is actually earned on this task. A score from 0 to 5 is received with lower score indicating better delay (preferred).
Delay Discounting
Delay Discounting Task is a brief, five-item task on a computer that asks participants their preference between $5 now and $10 at some later time point (Koffarnus, Warren, & Bickel, 2014). No money is actually earned on this task. A score from 0 to 5 is received with lower score indicating better delay (preferred).
Child Depression
Child Depression Inventory-Short Version (CDI-S): A 10-item measure that screens for depression (Kovacs, 2010). Scores can range from 0-24, with higher scores reflecting greater depression.
Child Depression
Child Depression Inventory-Short Version (CDI-S): A 10-item measure that screens for depression (Kovacs, 2010). Scores can range from 0-24, with higher scores reflecting greater depression.
Child Depression
Child Depression Inventory-Short Version (CDI-S): A 10-item measure that screens for depression (Kovacs, 2010). Scores can range from 0-24, with higher scores reflecting greater depression.
Child problem behaviors
Child Behavior Checklist (CBCL): Parents will complete the 113 items from the CBCL to assess adolescents' internalizing and externalizing symptoms (Achenbach et al., 2001). Raw scores range from 0-240. Higher scores reflect greater problems.
Child problem behaviors
Child Behavior Checklist (CBCL): Parents will complete the 113 items from the CBCL to assess adolescents' internalizing and externalizing symptoms (Achenbach et al., 2001). Raw scores range from 0-240. Higher scores reflect greater problems.
Child problem behaviors
Child Behavior Checklist (CBCL): Parents will complete the 113 items from the CBCL to assess adolescents' internalizing and externalizing symptoms (Achenbach et al., 2001). Raw scores range from 0-240. Higher scores reflect greater problems.
Adolescent substance use
Adolescents will complete the Youth Risk Behavior Survey. Higher scores reflect more substance use, with a possible range of 21-98.
Adolescent substance use
Adolescents will complete the Youth Risk Behavior Survey. Higher scores reflect more substance use, with a possible range of 21-98.
Adolescent substance use
Adolescents will complete the Youth Risk Behavior Survey. Higher scores reflect more substance use, with a possible range of 21-98.
Adolescent risky behaviors
Adolescents will complete the Youth Risk Behavior Survey. Higher scores reflect more risky problems, with a possible range of 8-28.
Adolescent risky behaviors
Adolescents will complete the Youth Risk Behavior Survey. Higher scores reflect more risky problems, with a possible range of 8-28.
Adolescent risky behaviors
Adolescents will complete the Youth Risk Behavior Survey. Higher scores reflect more risky problems, with a possible range of 8-28.
Mini-International Neuropsychiatric Interview for Children and Adolescents
Psychiatric interview. Higher scores reflect more psychiatric symptoms, with a range of 0-8.
Mini-International Neuropsychiatric Interview for Children and Adolescents
Psychiatric interview. Higher scores reflect more psychiatric symptoms, with a range of 0-8.
Emotional Regulation Questionnaire
Assesses how effectively adolescents regulate or control emotions. Higher scores reflect better regulation. Scores range from 10-50.
Secondary Outcome Measures
Full Information
NCT ID
NCT04168684
First Posted
September 24, 2019
Last Updated
September 28, 2023
Sponsor
University of Delaware
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT04168684
Brief Title
Intervening Early: Key Adolescent Outcomes
Acronym
SCOH-A
Official Title
Intervening Early With Neglected Children: Key Adolescent Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
August 2, 2019 (Actual)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Delaware
Collaborators
National Institute of Mental Health (NIMH)
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
This study follows children into adolescence who were first randomized to intervention condition in infancy.
Detailed Description
Parents serve as co-regulators for their young children, helping them regulate behaviors, emotions, and physiology and supporting the development of healthy brain circuitry. Neglecting parents often fail to serve as co-regulators, which has implications for young children's self-regulatory capabilities and brain development. As children become older, these difficulties with self-regulation may become more pronounced. Adolescence represents a period of particular vulnerability for the emergence of mental health problems because of increasing demands for regulation of emotions and behaviors, coupled with on-going development of neural circuits that support emotional and behavioral regulation. The Attachment and Biobehavioral Catch-up (ABC) intervention was designed to help parents learn to interact in responsive and sensitive ways, with the expectation that children would show enhanced ability to regulate behavior, emotions, and physiology. The efficacy of the ABC intervention among parents involved with Child Protective Services (CPS) was assessed. Parents were randomized to ABC or to a control intervention. Children were followed at T1 (ages 1-4) and T2 (ages 8-10). At T1, more of the children in the ABC group developed secure and organized attachments than children in the DEF group, and children in ABC showed more normative production of cortisol, less expression of negative emotions, and poorer inhibitory control than children in DEF. ABC parents were more sensitive and showed more optimal neural activity than DEF parents. At T2, ABC children showed greater prefrontal cortex activation in response to threat than DEF children, suggesting better regulation to threat at the level of brain activation. Also at T2, children in the ABC group reported more secure relationships with parents, and showed more normative cortisol production and more optimal autonomic nervous system functioning than DEF children. In adolescence, the ABC intervention is expected to result in enhanced brain circuitry and more optimal functioning across domains as assessed at multiple levels of analysis relative to the control intervention. In the proposed study, behavioral and neurobiological development among 13-, 14- and 15-year-old adolescents whose parents were referred by CPS to a randomized controlled trial in infancy (n=120), and among low-risk adolescents followed since middle childhood (n=80) will be assessed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Symptoms, Conduct Disorder, Anxiety Disorders
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
Families randomized to Attachment and Biobehavioral Catch-up (ABC) or to a control intervention (DEF)
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Parents received an intervention but did not know whether it was experimental or control. All participants had an identification number that did not indicate group.
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Attachment and Biobehavioral Catch-up (ABC)
Arm Type
Experimental
Arm Description
10 sessions that focused on parental nurturance, and sensitivity
Arm Title
Developmental Education for Families (DEF)
Arm Type
Active Comparator
Arm Description
10 sessions that focused on cognitive development
Intervention Type
Behavioral
Intervention Name(s)
Attachment and Biobehavioral Catch-up (ABC)
Intervention Description
Manualized intervention implemented in home with parent and child present focused on parental responsiveness
Intervention Type
Behavioral
Intervention Name(s)
Developmental Education for Families (DEF)
Intervention Description
Manualized intervention implemented in home with parent and child present focused on parental enhancement of child learning
Primary Outcome Measure Information:
Title
Brain activation in Stop Signal Task
Description
Prefrontal cortex activation assessed through functional magnetic resonance imaging (fMRI) in task requiring inhibitory control
Time Frame
Child age 13 years
Title
Brain activation in Mother-Stranger Task
Description
Functional connectivity assessed through fMRI when viewing photos of mothers vs. strangers
Time Frame
Age 13 years
Title
Brain activation in Mother-Stranger Task
Description
Functional connectivity assessed through fMRI when viewing photos of mothers vs. strangers
Time Frame
Age 15 years
Title
Brain activation in Emotion Go/Nogo task
Description
Functional connectivity between amygdala and PFC assessed through fMRI in an emotion go/no go task
Time Frame
Age 13 years
Title
Brain activation in Emotional Reappraisal Task
Description
Functional connectivity between amygdala and PFC assessed through fMRI in emotional reappraisal task
Time Frame
Age 14 years
Title
Brain activation in Emotion Go/Nogo task
Description
Functional connectivity between amygdala and PFC assessed through fMRI in an emotion go/no go task
Time Frame
Age 15 years
Title
Trier Social Stress Test- Cortisol
Description
Participants will be met by two research assistants (one male, one female), whom they have not met previously. The research assistants will tell the participants that they will have 5 minutes to prepare a speech which they will give to the researchers who will rate the speech. Participants will then give their speeches for 5 minutes; the research assistants will maintain neutral expressions and provide no feedback. Afterwards, participants will be asked to do (age-adjusted) mental arithmetic aloud (Buske-Kirschbaum et al.,1997). For the purpose of assessing cortisol, investigators will collect saliva samples before and after the speech/math.
Time Frame
Age 13 years
Title
Trier Social Stress Test-ANS
Description
Participants will be met by two research assistants (one male, one female), whom they have not met previously. The research assistants will tell the participants that they will have 5 minutes to prepare a speech which they will give to the researchers who will rate the speech. Participants will then give their speeches for 5 minutes; the research assistants will maintain neutral expressions and provide no feedback. Afterwards, participants will be asked to do (age-adjusted) mental arithmetic aloud (Buske-Kirschbaum et al.,1997).Assess child autonomic nervous system regulation, examine reactivity from baseline in RSA.
Time Frame
Age 13 years
Title
Revealed differences task - parent sensitivity.
Description
Parents and children engage in conflict discussion. Assess parental sensitivity using Sensitivity scale. Parental behavior is scored on a 1-7 scale, with higher scores reflecting greater sensitivity.
Time Frame
Age 13 years
Title
Support task- parent sensitivity
Description
Parents and children engage in support discussion (discussing Trier task from previous year). Assess parental sensitivity using Sensitivity scale. Parental behavior is scored on a 1-7 scale, with higher scores reflecting greater sensitivity.
Time Frame
Age 14 years
Title
Revealed differences task- parent sensitivity
Description
Parents and children engage in conflict discussion. Assess parental sensitivity using Sensitivity scale. Parental behavior is scored on a 1-7 scale, with higher scores reflecting greater sensitivity.
Time Frame
Age 15 years
Title
Revealed differences task-adolescent competence
Description
Parents and children engage in conflict discussion. Assess child competence in discussion on Competence scale. Competence is scored on a 1-7 scale, with higher scores reflecting greater competence.
Time Frame
Age 13 years
Title
Support task-adolescent competence
Description
Parents and children engage in conflict discussion. Assess child competence in discussion on Competence scale. Competence is scored on a 1-7 scale, with higher scores reflecting greater competence.
Time Frame
Age 14 years
Title
Revealed differences task-adolescent competence
Description
Parents and children engage in conflict discussion. Assess child competence in discussion on Competence scale. Competence is scored on a 1-7 scale, with higher scores reflecting greater competence.
Time Frame
15 years of age.
Title
Revealed differences task-adolescent ANS
Description
The control of cardiac functions via the vagal nerve, or vagal tone, is an index of parasympathetic activity. It can be measured by heart rate variability associated with respiration or high frequency respiratory sinus arrhythmia (RSA). RSA data will be collected continuously throughout the parent-child interaction using a MindWare Portable Lab system. Greater changes in RSA from baseline to discussion considered preferable.
Parents and children engage in conflict discussion. Assess child autonomic nervous system regulation. Respiratory sinus arrhythmia (RSA) will be measured as a rise from baseline.
Time Frame
13 years of age.
Title
Support task-adolescent ANS
Description
The control of cardiac functions via the vagal nerve, or vagal tone, is an index of parasympathetic activity. It can be measured by heart rate variability associated with respiration or high frequency respiratory sinus arrhythmia (RSA). RSA data will be collected continuously throughout the parent-child interaction using a MindWare Portable Lab system. Greater changes in RSA from baseline to discussion considered preferable.
Time Frame
14 years of age.
Title
Revealed differences task-adolescent ANS
Description
The control of cardiac functions via the vagal nerve, or vagal tone, is an index of parasympathetic activity. It can be measured by heart rate variability associated with respiration or high frequency respiratory sinus arrhythmia (RSA). RSA data will be collected continuously throughout the parent-child interaction using a MindWare Portable Lab system. Greater changes in RSA from baseline to discussion considered preferable.
Time Frame
15 years of age.
Title
Balloon Analogue Risk Task (BART)
Description
This task assesses risk-taking through a computer game in which participants see a balloon on the computer screen and have the option of pumping up the balloon more, and therefore increasing its monetary value, or stopping and collecting the value of the balloon. If the balloon pops on a pump, then all of the value of the balloon is lost and the next trial begins. There is a randomly, pre-determined probability of the balloon popping on any given pump of each trial. A brief version of the task with 15 balloons will be used. A running tally of participants' total monetary gain is kept (and can range from $0 up to a cap of $5). The amount of money earned is the score, with more money reflecting higher risk taking.
Time Frame
13 years of age
Title
Delay Discounting
Description
Delay Discounting Task is a brief, five-item task on a computer that asks participants their preference between $5 now and $10 at some later time point (Koffarnus, Warren, & Bickel, 2014). No money is actually earned on this task. A score from 0 to 5 is received with lower score indicating better delay (preferred).
Time Frame
13 years of age
Title
Delay Discounting
Description
Delay Discounting Task is a brief, five-item task on a computer that asks participants their preference between $5 now and $10 at some later time point (Koffarnus, Warren, & Bickel, 2014). No money is actually earned on this task. A score from 0 to 5 is received with lower score indicating better delay (preferred).
Time Frame
15 years of age
Title
Child Depression
Description
Child Depression Inventory-Short Version (CDI-S): A 10-item measure that screens for depression (Kovacs, 2010). Scores can range from 0-24, with higher scores reflecting greater depression.
Time Frame
13 years of age
Title
Child Depression
Description
Child Depression Inventory-Short Version (CDI-S): A 10-item measure that screens for depression (Kovacs, 2010). Scores can range from 0-24, with higher scores reflecting greater depression.
Time Frame
14 years of age
Title
Child Depression
Description
Child Depression Inventory-Short Version (CDI-S): A 10-item measure that screens for depression (Kovacs, 2010). Scores can range from 0-24, with higher scores reflecting greater depression.
Time Frame
15 years of age
Title
Child problem behaviors
Description
Child Behavior Checklist (CBCL): Parents will complete the 113 items from the CBCL to assess adolescents' internalizing and externalizing symptoms (Achenbach et al., 2001). Raw scores range from 0-240. Higher scores reflect greater problems.
Time Frame
13 years of age
Title
Child problem behaviors
Description
Child Behavior Checklist (CBCL): Parents will complete the 113 items from the CBCL to assess adolescents' internalizing and externalizing symptoms (Achenbach et al., 2001). Raw scores range from 0-240. Higher scores reflect greater problems.
Time Frame
14 years of age
Title
Child problem behaviors
Description
Child Behavior Checklist (CBCL): Parents will complete the 113 items from the CBCL to assess adolescents' internalizing and externalizing symptoms (Achenbach et al., 2001). Raw scores range from 0-240. Higher scores reflect greater problems.
Time Frame
15 years of age
Title
Adolescent substance use
Description
Adolescents will complete the Youth Risk Behavior Survey. Higher scores reflect more substance use, with a possible range of 21-98.
Time Frame
13 years of age
Title
Adolescent substance use
Description
Adolescents will complete the Youth Risk Behavior Survey. Higher scores reflect more substance use, with a possible range of 21-98.
Time Frame
14 years of age
Title
Adolescent substance use
Description
Adolescents will complete the Youth Risk Behavior Survey. Higher scores reflect more substance use, with a possible range of 21-98.
Time Frame
15 years of age
Title
Adolescent risky behaviors
Description
Adolescents will complete the Youth Risk Behavior Survey. Higher scores reflect more risky problems, with a possible range of 8-28.
Time Frame
13 years of age
Title
Adolescent risky behaviors
Description
Adolescents will complete the Youth Risk Behavior Survey. Higher scores reflect more risky problems, with a possible range of 8-28.
Time Frame
14 years of age
Title
Adolescent risky behaviors
Description
Adolescents will complete the Youth Risk Behavior Survey. Higher scores reflect more risky problems, with a possible range of 8-28.
Time Frame
15 years of age
Title
Mini-International Neuropsychiatric Interview for Children and Adolescents
Description
Psychiatric interview. Higher scores reflect more psychiatric symptoms, with a range of 0-8.
Time Frame
13 years of age
Title
Mini-International Neuropsychiatric Interview for Children and Adolescents
Description
Psychiatric interview. Higher scores reflect more psychiatric symptoms, with a range of 0-8.
Time Frame
14 years of age
Title
Emotional Regulation Questionnaire
Description
Assesses how effectively adolescents regulate or control emotions. Higher scores reflect better regulation. Scores range from 10-50.
Time Frame
14 years of age
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Must have been included in middle childhood data collection
Exclusion Criteria:
None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Dozier, Ph.D.
Organizational Affiliation
University of Delaware
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Delaware
City
Newark
State/Province
Delaware
ZIP/Postal Code
19716
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
As described below, data will be made available to the scientific community for further analysis and novel research purposes after the primary results of the study have been published.
De-identified research data will be shared in spreadsheet format for all clinical assessment, survey, and behavioral data. MRI data will be shared in NIFTI format. A description of the variables that are included in the dataset as well as a description of the data collection methods will also be provided. All data sharing will be done in consultation with our IRB.
Results will be shared within one year of the completion of data collection of primary outcome measures.
IPD Sharing Time Frame
12 months following final data collection for at least 3 years.
Learn more about this trial
Intervening Early: Key Adolescent Outcomes
We'll reach out to this number within 24 hrs