Integrated Model for Promoting Parenting and Early School Readiness in Pediatrics
Primary Purpose
Infant Behavior, Child Behavior, Parenting
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Video Interaction Project
Family Check Up
Sponsored by
About this trial
This is an interventional prevention trial for Infant Behavior focused on measuring Infant behavior, Child behavior, Parenting, Child rearing, Depression, Personal satisfaction, Randomized controlled trials, Intervention studies, Behavioral symptoms, Social behavior
Eligibility Criteria
Inclusion Criteria:
- Baby is getting pediatric care at Bellevue Hospital Center or Pittsburgh Children's Hospital
- Caregiver primary language is English or Spanish
- Family can be contacted (has a working phone)
- Family attended second (follow-up) meeting with study team between when the child was aged 10days and 6weeks old
Exclusion Criteria:
- Birth weight <2500gm
- Gestational age < 37 weeks
- Not singleton birth (twin, triplet, etc.)
- Known or suspected significant genetic abnormality
- Known neurodevelopmental/neuromuscular disorder likely to affect development, movement, e.g., seizure disorder, microcephaly (low head circumference)
- Known sensory defect
- Known significant malformation likely to affect development or likely to require significant therapy
- Meets criteria for Early Intervention at birth
- Not in level I nursery at time of enrollment
- Significant postnatal complication requiring level II or III nursery stay. Examples: sepsis, significant hypoglycemia, seizures
- Mother with known significant impairment that will be barrier to communication and participation (e.g., intellectual disability, schizophrenia)
- Baby not being discharged to mother or father
- Mother and baby will be staying in shelter
- Not planning to stay in NYC/ Pittsburgh for at least 3 years
- Has previously participated in VIP or FCU projects
- Baby experiencing significant medical issues
- Doctor has concerns about baby's hearing or vision
Sites / Locations
- Bellevue Hospital Center
- Children's Hospital of Pittsburgh
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
VIP/FCU
Control
Arm Description
VIP (Video Interaction Project) will be offered to all families assigned to the treatment group. FCU (Family Check Up) will be offered to families identified as high risk within the treatment group. Both treatments are parenting interventions.
Outcomes
Primary Outcome Measures
Caregiver's cognitive stimulation
Caregiver's reports of cognitive stimulation. For example engagement in reading, teaching, and play (e.g., StimQ, Dreyer, Mendelsohn, & Tamis-LeMonda, 1995; Mendelsohn, Dreyer, & Tamis-LeMonda, 1999)
Caregiver's harsh parenting and discipline
Caregiver's reports of discipline strategies (e.g., Socolar et al., 2004; Incredible Years, Webster-Stratton, 2001; Steele et al., 2005)
Caregiver-child interaction quality
Caregiver's reports and coded videotaped interactions between caregivers and children (e.g., Parenting Young Children, PARYC; McEachern et al., 2011)
Quality of the home environment
Observer reports of the home environment (e.g., HOME inventory: Infant-Toddler (IT), Bradley & Caldwell, 1984)
Caregiver depression
Caregiver's reports of depression (Edinburgh Postnatal Depression Scale (EPDS), Cox, Holden & Sagovsky, 1987; Cox, Chapman, Declan & Jones, 1995)
Caregiver stress/ support
Caregiver's reports of stress, support, and perceptions of daily hassles (e.g., Abidin Parenting Stress Index, Abidin, 1990; General Life Satisfaction Questionnaire, Crnic, 1983; Parenting Daily Hassle scale, Crnic & Greenberg, 1990; Concern for Children scale, Vines & Baird, 2009)
Child prosocial and problem behavior
Caregiver's reports of their child's behavioral problems, including externalizing and internalizing problems and prosocial behavior and social skills (e.g., Child Behavior Checklist; Achenbach & Rescorla, 2000; BASC-3, Altmann et al., 2017; Infant-Toddler Social Emotional Assessment, ITSEA, Carter & Briggs-Gowan, 1993; Brief Infant Toddler Social Emotional Assessment, BITSEA, Briggs-Gowan & Carter, 2006; Positive Behavior Scale, Epps et al., 2003)
Children's early language skills
Caregiver report of non-verbal communication and early expressive language (e.g., MacArthur Communicative Development Inventory; CDI, Fenson et al., 2008; Communication and Symbolic Behavior Scale, CSBS, Wetherby et al., 2001)
Child achievement
Direct assessment of children's achievement, including receptive language skills, early academic skills including, reading, math, and writing as well as oral language abilities and academic knowledge (e.g., Receptive One-Word Picture Vocabulary Tests; ROWPVT, Martin and Brownell, 2010; Woodcock Johnson-IV Letter-Word Identification, Applied Problems and Oral Language Comprehension (WJ-IV)/ Bateria III Woodcock-Munoz, Muñoz-Sandoval et al., 2007; McGrew et al., 2014; Test of Word Reading Eficiency (TOWRE), Tarar et al., 2015)
Child executive functioning skills
Direct assessment of children's executive functioning, including cognitive skills, inhibitory control, and effortful control (e.g., Dimensional Change Card Sort, DCCS, Zelazo, 2006; Walk a Line, Cookie Waiting, Kochanska et al., 2000)
Caregiver-child relationship quality
Caregiver's reports of relationship quality, including the caregiver's perception of conflict and warmth/openness in relationship with the child (e.g., Adult Child Relationship Scale, Pianta & Steinberg, 1991)
Children's self-regulation
Observer reports of children's attention/emotional regulation during the direct assessment (e.g., Preschool Self-Regulation Interviewer Assessment, PSRA, Smith-Donald et al., 2007; Moffit Scale, Caspi et al., 1995)
Secondary Outcome Measures
Parenting Quality
Examiner impressions of parenting quality, including measures of responsivity, acceptance, involvement, social skills, and affect. (e.g., items adapted from HOME inventory: Infant-Toddler (IT), Bradley & Caldwell, 1984)
Child temperament
Caregiver's reports of their child's temperament (e.g., Infant Characteristics Questionnaire, Bates, Freeland, & Lounsbury, 1979; Children's Behavior Questionnaire, CBQ, Rothbart, 2007)
Special services
Caregiver's reports of their child's Early Intervention referrals and services received
Basic child health
Attendance in well-child care, growth/ nutrition
Caregiver-child relationship quality
Caregiver's reports of relationship quality, including the caregiver's perception of conflict and warmth/openness in relationship with the child (e.g., Adult Child Relationship Scale, Pianta & Steinberg, 1991)
Caregiver routines and activities
Caregiver's reports of routines and activities, including, play, planning, feeding, sleep and media (e.g., McEachern, Dishion, Weaver, Shaw, Wilson, Gardner, 2012; Mendelsohn et al., 2008; Infant Feeding Style Questionnaire, Thompson, A. L., et al. 2009; Parent Teacher Involvement, Kohl et al., 2000)
Caregiver relationship satisfaction
Caregiver's reports of relationship satisfaction and conflict (e.g., Dyadic Adjustment Scale, Spanier, 1976)
Caregiver regulation of negative emotion
Caregiver's reports of their ability to maintain emotional equilibrium when faced with child rearing challenges (e.g., Raver, 2003) and difficulties with emotion regulation (Kaufman et al., 2015)
Caregiver confidence
Caregiver's reports of their self-efficacy and beliefs related to children's behavior and school readiness. readiness (e.g., adapted Pachter, Sheehan & Cloutier, 2000; Parenting Self-Agency Measure, PSAM, Dumka et al., 1996)
Child narrative comprehension
Direct assessment of children's ability to understand and retell narratives, and use higher-order language (e.g., Reese et al., 2012)
Child Theory of Mind
Direct assessment of children's ability to mentally represent others' internal states, including measures of false belief and memory control (e.g., Mahy et al., 2017)
Caregiver Mindfulness
Caregiver's reports of mindfulness in parenting behavior (e.g., Interpersonal Mindfulness in Parenting, IM-P, Duncan, 2007)
Full Information
NCT ID
NCT02459327
First Posted
May 26, 2015
Last Updated
November 1, 2022
Sponsor
New York University
Collaborators
NYU Langone Health, University of Pittsburgh
1. Study Identification
Unique Protocol Identification Number
NCT02459327
Brief Title
Integrated Model for Promoting Parenting and Early School Readiness in Pediatrics
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 3, 2015 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York University
Collaborators
NYU Langone Health, University of Pittsburgh
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study tests a comprehensive approach to the promotion of school readiness in low-income families, beginning shortly after the birth of the child, through enhancement of positive parenting practices (and when present, reduction of psychosocial stressors) within the pediatric primary care platform. The investigators do so by integrating two evidence-based interventions: 1) a universal primary prevention strategy (Video Interaction Project [VIP]); and 2) a targeted secondary/tertiary prevention strategy (Family Check-up [FCU]) for families with infants/toddlers identified as having additional risks. VIP provides parents with a developmental specialist who videotapes the parent and child and coaches the parent on effective parenting practices at each pediatric primary care visit. FCU is a home-based, family-centered intervention that utilizes an initial ecologically-focused assessment to promote motivation for parents to change child-rearing behaviors, with follow-up sessions on parenting and factors that compromise parenting quality.
Two primary care settings serving low-income communities in New York City, NY and Pittsburgh, PA will be utilized to test this integrated intervention in hospital-based clinics, providing information about translation across venues where one of the two interventions has been previously used alone.
The investigators plan to test the VIP/FCU model in a randomized trial of 400 families utilizing parent surveys, observational data on parent-child interactions, and direct assessments of children's development, at key points during intervention follow-up. Analyses will address questions of program impact for the integrated program across all families and by key subgroups.
The largest single contribution made by this study is to test whether an integrated primary and secondary/tertiary prevention strategy implemented in pediatric primary care can produce impacts on early school readiness outcomes, including social-emotional, pre-academic, and self-regulation. As such, this study has the potential to provide the scientific and practice communities with information about an innovative approach to promoting school readiness skills among low-income children.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant Behavior, Child Behavior, Parenting, Child Rearing, Depression, Personal Satisfaction, Behavioral Symptoms, Social Control, Informal
Keywords
Infant behavior, Child behavior, Parenting, Child rearing, Depression, Personal satisfaction, Randomized controlled trials, Intervention studies, Behavioral symptoms, Social behavior
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
403 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VIP/FCU
Arm Type
Experimental
Arm Description
VIP (Video Interaction Project) will be offered to all families assigned to the treatment group. FCU (Family Check Up) will be offered to families identified as high risk within the treatment group. Both treatments are parenting interventions.
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Video Interaction Project
Other Intervention Name(s)
VIP
Intervention Description
VIP utilizes pediatric well-child visits to build a relationship with an interventionist who facilitates self-reflection regarding interactions with the child through review of videotapes of the parent and child made that day and further facilitates interactions through provision of learning materials (toys and books).
Intervention Type
Behavioral
Intervention Name(s)
Family Check Up
Other Intervention Name(s)
FCU
Intervention Description
FCU utilizes home visitation to build a relationship with an interventionist who assesses family strengths and challenges and uses motivational interviewing and evidence-based family management strategies to support parent and child behavioral change.
Primary Outcome Measure Information:
Title
Caregiver's cognitive stimulation
Description
Caregiver's reports of cognitive stimulation. For example engagement in reading, teaching, and play (e.g., StimQ, Dreyer, Mendelsohn, & Tamis-LeMonda, 1995; Mendelsohn, Dreyer, & Tamis-LeMonda, 1999)
Time Frame
When the child is 6 months - 6 years old
Title
Caregiver's harsh parenting and discipline
Description
Caregiver's reports of discipline strategies (e.g., Socolar et al., 2004; Incredible Years, Webster-Stratton, 2001; Steele et al., 2005)
Time Frame
When the child is 18 months - 6 years old
Title
Caregiver-child interaction quality
Description
Caregiver's reports and coded videotaped interactions between caregivers and children (e.g., Parenting Young Children, PARYC; McEachern et al., 2011)
Time Frame
When the child is 6 months - 6 years old
Title
Quality of the home environment
Description
Observer reports of the home environment (e.g., HOME inventory: Infant-Toddler (IT), Bradley & Caldwell, 1984)
Time Frame
When the child is 18 months old
Title
Caregiver depression
Description
Caregiver's reports of depression (Edinburgh Postnatal Depression Scale (EPDS), Cox, Holden & Sagovsky, 1987; Cox, Chapman, Declan & Jones, 1995)
Time Frame
When the child is 6 months - 6 years old
Title
Caregiver stress/ support
Description
Caregiver's reports of stress, support, and perceptions of daily hassles (e.g., Abidin Parenting Stress Index, Abidin, 1990; General Life Satisfaction Questionnaire, Crnic, 1983; Parenting Daily Hassle scale, Crnic & Greenberg, 1990; Concern for Children scale, Vines & Baird, 2009)
Time Frame
When the child is 6 months - 6 years old
Title
Child prosocial and problem behavior
Description
Caregiver's reports of their child's behavioral problems, including externalizing and internalizing problems and prosocial behavior and social skills (e.g., Child Behavior Checklist; Achenbach & Rescorla, 2000; BASC-3, Altmann et al., 2017; Infant-Toddler Social Emotional Assessment, ITSEA, Carter & Briggs-Gowan, 1993; Brief Infant Toddler Social Emotional Assessment, BITSEA, Briggs-Gowan & Carter, 2006; Positive Behavior Scale, Epps et al., 2003)
Time Frame
When the child is 6 months - 6 years old
Title
Children's early language skills
Description
Caregiver report of non-verbal communication and early expressive language (e.g., MacArthur Communicative Development Inventory; CDI, Fenson et al., 2008; Communication and Symbolic Behavior Scale, CSBS, Wetherby et al., 2001)
Time Frame
When the child is 6 months - 2 years old
Title
Child achievement
Description
Direct assessment of children's achievement, including receptive language skills, early academic skills including, reading, math, and writing as well as oral language abilities and academic knowledge (e.g., Receptive One-Word Picture Vocabulary Tests; ROWPVT, Martin and Brownell, 2010; Woodcock Johnson-IV Letter-Word Identification, Applied Problems and Oral Language Comprehension (WJ-IV)/ Bateria III Woodcock-Munoz, Muñoz-Sandoval et al., 2007; McGrew et al., 2014; Test of Word Reading Eficiency (TOWRE), Tarar et al., 2015)
Time Frame
When the child is 4 years old - 6 years old
Title
Child executive functioning skills
Description
Direct assessment of children's executive functioning, including cognitive skills, inhibitory control, and effortful control (e.g., Dimensional Change Card Sort, DCCS, Zelazo, 2006; Walk a Line, Cookie Waiting, Kochanska et al., 2000)
Time Frame
When the child is 4 years old - 6 years old
Title
Caregiver-child relationship quality
Description
Caregiver's reports of relationship quality, including the caregiver's perception of conflict and warmth/openness in relationship with the child (e.g., Adult Child Relationship Scale, Pianta & Steinberg, 1991)
Time Frame
When the child is 4 years old - 6 years old
Title
Children's self-regulation
Description
Observer reports of children's attention/emotional regulation during the direct assessment (e.g., Preschool Self-Regulation Interviewer Assessment, PSRA, Smith-Donald et al., 2007; Moffit Scale, Caspi et al., 1995)
Time Frame
When the child is 4 years old - 6 years old
Secondary Outcome Measure Information:
Title
Parenting Quality
Description
Examiner impressions of parenting quality, including measures of responsivity, acceptance, involvement, social skills, and affect. (e.g., items adapted from HOME inventory: Infant-Toddler (IT), Bradley & Caldwell, 1984)
Time Frame
Time Frame: When the child is 2 - 4 years old
Title
Child temperament
Description
Caregiver's reports of their child's temperament (e.g., Infant Characteristics Questionnaire, Bates, Freeland, & Lounsbury, 1979; Children's Behavior Questionnaire, CBQ, Rothbart, 2007)
Time Frame
When the child is 6 months, 4 years old, 6 years old
Title
Special services
Description
Caregiver's reports of their child's Early Intervention referrals and services received
Time Frame
When the child is 6 months - 6 years old
Title
Basic child health
Description
Attendance in well-child care, growth/ nutrition
Time Frame
When the child is 6 months - 6 years old
Title
Caregiver-child relationship quality
Description
Caregiver's reports of relationship quality, including the caregiver's perception of conflict and warmth/openness in relationship with the child (e.g., Adult Child Relationship Scale, Pianta & Steinberg, 1991)
Time Frame
When the child is 18 months - 2 years old
Title
Caregiver routines and activities
Description
Caregiver's reports of routines and activities, including, play, planning, feeding, sleep and media (e.g., McEachern, Dishion, Weaver, Shaw, Wilson, Gardner, 2012; Mendelsohn et al., 2008; Infant Feeding Style Questionnaire, Thompson, A. L., et al. 2009; Parent Teacher Involvement, Kohl et al., 2000)
Time Frame
When the child is 6 months - 6 years old
Title
Caregiver relationship satisfaction
Description
Caregiver's reports of relationship satisfaction and conflict (e.g., Dyadic Adjustment Scale, Spanier, 1976)
Time Frame
When the child is 6 months - 6 years old
Title
Caregiver regulation of negative emotion
Description
Caregiver's reports of their ability to maintain emotional equilibrium when faced with child rearing challenges (e.g., Raver, 2003) and difficulties with emotion regulation (Kaufman et al., 2015)
Time Frame
When the child is 24 months old and 6 years old
Title
Caregiver confidence
Description
Caregiver's reports of their self-efficacy and beliefs related to children's behavior and school readiness. readiness (e.g., adapted Pachter, Sheehan & Cloutier, 2000; Parenting Self-Agency Measure, PSAM, Dumka et al., 1996)
Time Frame
When the child is 6 months - 4 years old
Title
Child narrative comprehension
Description
Direct assessment of children's ability to understand and retell narratives, and use higher-order language (e.g., Reese et al., 2012)
Time Frame
When the child is 4 years old - 6 years old
Title
Child Theory of Mind
Description
Direct assessment of children's ability to mentally represent others' internal states, including measures of false belief and memory control (e.g., Mahy et al., 2017)
Time Frame
When the child is 4 years old
Title
Caregiver Mindfulness
Description
Caregiver's reports of mindfulness in parenting behavior (e.g., Interpersonal Mindfulness in Parenting, IM-P, Duncan, 2007)
Time Frame
When the child is 18 months old
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Baby is getting pediatric care at Bellevue Hospital Center or Pittsburgh Children's Hospital
Caregiver primary language is English or Spanish
Family can be contacted (has a working phone)
Family attended second (follow-up) meeting with study team between when the child was aged 10days and 6weeks old
Exclusion Criteria:
Birth weight <2500gm
Gestational age < 37 weeks
Not singleton birth (twin, triplet, etc.)
Known or suspected significant genetic abnormality
Known neurodevelopmental/neuromuscular disorder likely to affect development, movement, e.g., seizure disorder, microcephaly (low head circumference)
Known sensory defect
Known significant malformation likely to affect development or likely to require significant therapy
Meets criteria for Early Intervention at birth
Not in level I nursery at time of enrollment
Significant postnatal complication requiring level II or III nursery stay. Examples: sepsis, significant hypoglycemia, seizures
Mother with known significant impairment that will be barrier to communication and participation (e.g., intellectual disability, schizophrenia)
Baby not being discharged to mother or father
Mother and baby will be staying in shelter
Not planning to stay in NYC/ Pittsburgh for at least 3 years
Has previously participated in VIP or FCU projects
Baby experiencing significant medical issues
Doctor has concerns about baby's hearing or vision
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pamela Morris, Ph.D
Organizational Affiliation
New York University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alan Mendelsohn, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Daniel Shaw, Ph.D
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bellevue Hospital Center
City
New York
State/Province
New York
ZIP/Postal Code
11211
Country
United States
Facility Name
Children's Hospital of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
15718881
Citation
Mendelsohn AL, Dreyer BP, Flynn V, Tomopoulos S, Rovira I, Tineo W, Pebenito C, Torres C, Torres H, Nixon AF. Use of videotaped interactions during pediatric well-child care to promote child development: a randomized, controlled trial. J Dev Behav Pediatr. 2005 Feb;26(1):34-41.
Results Reference
background
PubMed Identifier
16551138
Citation
Shaw DS, Dishion TJ, Supplee L, Gardner F, Arnds K. Randomized trial of a family-centered approach to the prevention of early conduct problems: 2-year effects of the family check-up in early childhood. J Consult Clin Psychol. 2006 Feb;74(1):1-9. doi: 10.1037/0022-006X.74.1.1.
Results Reference
background
PubMed Identifier
18826532
Citation
Dishion TJ, Shaw D, Connell A, Gardner F, Weaver C, Wilson M. The family check-up with high-risk indigent families: preventing problem behavior by increasing parents' positive behavior support in early childhood. Child Dev. 2008 Sep-Oct;79(5):1395-414. doi: 10.1111/j.1467-8624.2008.01195.x.
Results Reference
background
PubMed Identifier
21199978
Citation
Mendelsohn AL, Huberman HS, Berkule SB, Brockmeyer CA, Morrow LM, Dreyer BP. Primary care strategies for promoting parent-child interactions and school readiness in at-risk families: the Bellevue Project for Early Language, Literacy, and Education Success. Arch Pediatr Adolesc Med. 2011 Jan;165(1):33-41. doi: 10.1001/archpediatrics.2010.254.
Results Reference
background
PubMed Identifier
35775199
Citation
Reno R, Whipps M, Wallenborn JT, Demirci J, Bogen DL, Gross RS, Mendelsohn AL, Morris PA, Shaw DS. Housing Insecurity, Housing Conditions, and Breastfeeding Behaviors for Medicaid-Eligible Families in Urban Settings. J Hum Lact. 2022 Nov;38(4):760-770. doi: 10.1177/08903344221108073. Epub 2022 Jul 1.
Results Reference
derived
PubMed Identifier
33608413
Citation
Roby E, Miller EB, Shaw DS, Morris P, Gill A, Bogen DL, Rosas J, Canfield CF, Hails KA, Wippick H, Honoroff J, Cates CB, Weisleder A, Chadwick KA, Raak CD, Mendelsohn AL. Improving Parent-Child Interactions in Pediatric Health Care: A Two-Site Randomized Controlled Trial. Pediatrics. 2021 Mar;147(3):e20201799. doi: 10.1542/peds.2020-1799.
Results Reference
derived
PubMed Identifier
32352828
Citation
Canfield CF, Miller EB, Shaw DS, Morris P, Alonso A, Mendelsohn AL. Beyond language: Impacts of shared reading on parenting stress and early parent-child relational health. Dev Psychol. 2020 Jul;56(7):1305-1315. doi: 10.1037/dev0000940. Epub 2020 Apr 30.
Results Reference
derived
Learn more about this trial
Integrated Model for Promoting Parenting and Early School Readiness in Pediatrics
We'll reach out to this number within 24 hrs