Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Integrated Model for Promoting Parenting and Early School Readiness in Pediatrics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02459327
Recruitment Status : Active, not recruiting
First Posted : June 2, 2015
Last Update Posted : April 2, 2020
Sponsor:
Collaborators:
NYU Langone Health
University of Pittsburgh
Information provided by (Responsible Party):
Pamela Morris, New York University

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.


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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 403 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Actual Study Start Date : May 2015
Estimated Primary Completion Date : May 2024
Estimated Study Completion Date : May 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: VIP/FCU
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



Primary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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)

  11. 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)

  12. 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)


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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

  4. Basic child health [ Time Frame: When the child is 6 months - 4 years old ]
    Attendance in well-child care, growth/ nutrition

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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)

  11. 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)

  12. 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Locations
Layout table for location information
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
Sponsors and Collaborators
New York University
NYU Langone Health
University of Pittsburgh
Investigators
Layout table for investigator information
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

Publications:
Layout table for additonal information
Responsible Party: Pamela Morris, Professor, New York University
ClinicalTrials.gov Identifier: NCT02459327    
Other Study ID Numbers: 1R01HD07639001A1
First Posted: June 2, 2015    Key Record Dates
Last Update Posted: April 2, 2020
Last Verified: March 2020
Keywords provided by Pamela Morris, New York University:
Infant behavior
Child behavior
Parenting
Child rearing
Depression
Personal satisfaction
Randomized controlled trials
Intervention studies
Behavioral symptoms
Social behavior
Additional relevant MeSH terms:
Layout table for MeSH terms
Depression
Behavioral Symptoms