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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02459327
Other study ID # 1R01HD07639001A1
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date June 3, 2015
Est. completion date June 30, 2024

Study information

Verified date November 2023
Source New York University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 403
Est. completion date June 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 0 Years and older
Eligibility 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

Study Design


Intervention

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).
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.

Locations

Country Name City State
United States Bellevue Hospital Center New York New York
United States Children's Hospital of Pittsburgh Pittsburgh Pennsylvania

Sponsors (3)

Lead Sponsor Collaborator
New York University NYU Langone Health, University of Pittsburgh

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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) When the child is 6 months - 6 years old
Primary 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) When the child is 18 months - 6 years old
Primary 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) When the child is 6 months - 6 years old
Primary Quality of the home environment Observer reports of the home environment (e.g., HOME inventory: Infant-Toddler (IT), Bradley & Caldwell, 1984) When the child is 18 months old
Primary Caregiver depression Caregiver's reports of depression (Edinburgh Postnatal Depression Scale (EPDS), Cox, Holden & Sagovsky, 1987; Cox, Chapman, Declan & Jones, 1995) When the child is 6 months - 6 years old
Primary 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) When the child is 6 months - 6 years old
Primary 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) When the child is 6 months - 6 years old
Primary 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) When the child is 6 months - 2 years old
Primary 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) When the child is 4 years old - 6 years old
Primary 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) When the child is 4 years old - 6 years old
Primary 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) When the child is 4 years old - 6 years old
Primary 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) When the child is 4 years old - 6 years old
Secondary 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) Time Frame: When the child is 2 - 4 years old
Secondary 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) When the child is 6 months, 4 years old, 6 years old
Secondary Special services Caregiver's reports of their child's Early Intervention referrals and services received When the child is 6 months - 6 years old
Secondary Basic child health Attendance in well-child care, growth/ nutrition When the child is 6 months - 6 years old
Secondary 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) When the child is 18 months - 2 years old
Secondary 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) When the child is 6 months - 6 years old
Secondary Caregiver relationship satisfaction Caregiver's reports of relationship satisfaction and conflict (e.g., Dyadic Adjustment Scale, Spanier, 1976) When the child is 6 months - 6 years old
Secondary 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) When the child is 24 months old and 6 years old
Secondary 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) When the child is 6 months - 4 years old
Secondary 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) When the child is 4 years old - 6 years old
Secondary 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) When the child is 4 years old
Secondary Caregiver Mindfulness Caregiver's reports of mindfulness in parenting behavior (e.g., Interpersonal Mindfulness in Parenting, IM-P, Duncan, 2007) When the child is 18 months old
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