Integrated Model for Promoting Parenting and Early School Readiness in Pediatrics
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|ClinicalTrials.gov Identifier: NCT02459327|
Recruitment Status : Active, not recruiting
First Posted : June 2, 2015
Last Update Posted : April 2, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Infant Behavior Child Behavior Parenting Child Rearing Depression Personal Satisfaction Behavioral Symptoms Social Control, Informal||Behavioral: Video Interaction Project Behavioral: Family Check Up||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||403 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Actual Study Start Date :||May 2015|
|Estimated Primary Completion Date :||May 2024|
|Estimated Study Completion Date :||May 2024|
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.
Behavioral: Video Interaction Project
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).
Other Name: VIP
Behavioral: Family Check Up
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.
Other Name: FCU
|No Intervention: Control|
- Caregiver's cognitive stimulation [ Time Frame: When the child is 6 months - 4 years old ]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 [ Time Frame: When the child is 18 months - 4 years old ]Caregiver's reports of discipline strategies (e.g., Socolar et al., 2004; Incredible Years, Webster-Stratton, 2001)
- Caregiver-child interaction quality [ Time Frame: When the child is 6 months - 4 years old ]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 [ Time Frame: When the child is 18 months old ]Observer reports of the home environment (e.g., HOME inventory: Infant-Toddler (IT), Bradley & Caldwell, 1984)
- Caregiver depression [ Time Frame: When the child is 6 months - 4 years old ]Caregiver's reports of depression (Edinburgh Postnatal Depression Scale (EPDS), Cox, Holden & Sagovsky, 1987; Cox, Chapman, Declan & Jones, 1995)
- Caregiver stress/ support [ Time Frame: When the child is 6 months - 4 years old ]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)
- Child prosocial and problem behavior [ Time Frame: When the child is 6 months - 4 years old ]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)
- Children's early language skills [ Time Frame: When the child is 6 months - 2 years old ]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 [ Time Frame: When the child is 4 years old ]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 and Applied Problems (WJ-IV)/ Bateria III Woodcock-Munoz, Muñoz-Sandoval et al., 2007; McGrew et al., 2014)
- Child executive functioning skills [ Time Frame: When the child is 4 years old ]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 [ Time Frame: When the child is 4 years old ]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 [ Time Frame: When the child is 4 years old ]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)
- Parenting Quality [ Time Frame: Time Frame: When the child is 2 - 4 years old ]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 [ Time Frame: When the child is 6 months, 4 years old ]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 [ Time Frame: When the child is 6 months - 4 years old ]Caregiver's reports of their child's Early Intervention referrals and services received
- Basic child health [ Time Frame: When the child is 6 months - 4 years old ]Attendance in well-child care, growth/ nutrition
- Caregiver-child relationship quality [ Time Frame: When the child is 18 months - 2 years old ]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 [ Time Frame: When the child is 6 months - 4 years old ]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)
- Caregiver relationship satisfaction [ Time Frame: When the child is 6 months - 4 years old ]Caregiver's reports of relationship satisfaction and conflict (e.g., Dyadic Adjustment Scale, Spanier, 1976)
- Caregiver regulation of negative emotion [ Time Frame: When the child is 24 months old ]Caregiver's reports of their ability to maintain emotional equilibrium when faced with child rearing challenges (e.g., Raver, 2003)
- Caregiver confidence [ Time Frame: When the child is 6 months - 4 years old ]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 [ Time Frame: When the child is 4 years old ]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 [ Time Frame: When the child is 4 years old ]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 [ Time Frame: When the child is 18 months old ]Caregiver's reports of mindfulness in parenting behavior (e.g., Interpersonal Mindfulness in Parenting, IM-P, Duncan, 2007)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02459327
|United States, New York|
|Bellevue Hospital Center|
|New York, New York, United States, 11211|
|United States, Pennsylvania|
|Children's Hospital of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15224|
|Principal Investigator:||Pamela Morris, Ph.D||New York University|
|Principal Investigator:||Alan Mendelsohn, MD||NYU Langone Health|
|Principal Investigator:||Daniel Shaw, Ph.D||University of Pittsburgh|