Improving Parent-Child Interactions to Enhance Child Health

Overview

Childhood obesity is a formidable public health issue in the United States, disproportionately affecting children from lower socioeconomic status households. Onset of obesity predicts cardiometabolic risks and other health problems in adolescence and into adulthood; thus, effective and early prevention is critical. Healthy parenting may play a pivotal role in preventing early childhood obesity. Warm, responsive, and consistent parenting is associated with the development of child self-regulation as well as healthy eating and physical activity practices, and thus may be protective against obesity risk. Targeting the parent-child relationship may be especially important when facilitating behavior change in parents who have ongoing stressors (e.g., low-income families). The proposed study aims to test an adaptation of Parent-Child Interaction Therapy (PCIT), an innovative parent management program that improves the parent-child relationship and enhances general parenting skills through the use of therapeutic in vivo coaching. Our adapted version, PCIT-Health, is a selective-prevention intervention that includes content specific to improving parent-child interactions and parenting in obesity-salient contexts, such as mealtime and child screen time. This project will elucidate novel approaches to, and novel targets of, early childhood obesity prevention and will provide data critical to test PCIT-Health in a large-scale randomized controlled trial. Parent-child dyads will be randomly assigned to PCIT-Health or a waitlist control in order to accomplish the following aims: AIM 1: To assess the acceptability and feasibility of the PCIT-Health delivery and assessment methods in low-income parents of overweight young children ages 3 to 6 years. AIM 2: To test the preliminary efficacy and estimate the effect size of PCIT-Health on changes in child BMI z-score (primary outcome) from baseline to (1) intervention completion and (2) 6-month post-intervention. AIM 3: To explore the effect of PCIT-Health on the following secondary outcomes: (1) parent-child relationship quality, (2) parent behavior management skills, (3) child self-regulation, (4) child eating behaviors, (5) child physical activity, and (6) child screen media use.

Full Title of Study: “Improving Parent-Child Interactions to Prevent Child Obesity in Early Childhood”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: July 2021

Interventions

  • Behavioral: PCIT-Health
    • PCIT-Health (also known as Parents Active in Their Children’s Health; PATCH) is an adaptation of Parent-Child Interaction Therapy. PCIT-Health targets (1) the parent-child relationship and (2) parenting efficacy both in general contexts (child play time and clean up time) and specifically in the context of obesity risk-related behaviors (child feeding, family mealtime, and child screen time).

Arms, Groups and Cohorts

  • Experimental: PCIT-Health
    • Participants assigned to the PCIT-Health arm will receive the intervention.
  • No Intervention: Wait list control
    • Participants in the wait list control will receive an invitation to participate in the intervention 10 months after baseline data collection.

Clinical Trial Outcome Measures

Primary Measures

  • Change in Child Body Mass Index (BMI) and BMI z-score
    • Time Frame: Pre-intervention, post-intervention (4 months after pre-intervention), and six-month follow-up (10 months after pre-intervention)
    • Change in child BMI will be calculated using standardized anthropometric measurement (height and weight) procedure

Secondary Measures

  • Child self-regulation (parent report)
    • Time Frame: Pre-intervention, post-intervention (4 months after pre-intervention), and six-month follow-up (10 months after pre-intervention)
    • Emotion Regulation Checklist
  • Child screen time
    • Time Frame: Pre-intervention, post-intervention (4 months after pre-intervention), and six-month follow-up (10 months after pre-intervention)
    • Parent report of daily amount of time child spends viewing/using screen media
  • Child Physical Activity
    • Time Frame: Pre-intervention, post-intervention (4 months after pre-intervention), and six-month follow-up (10 months after pre-intervention)
    • Measured by Actigraph accelerometer to assess sedentary, moderate, moderate-to-vigorous, and vigorous physical activity
  • Child sleep (parent report)
    • Time Frame: Pre-intervention, post-intervention (4 months after pre-intervention), and six-month follow-up (10 months after pre-intervention)
    • Measured by parent report of bedtime, wake time, and naps.
  • Child sleep (via actigraphy)
    • Time Frame: Pre-intervention, post-intervention (4 months after pre-intervention), and six-month follow-up (10 months after pre-intervention)
    • Measured by Actigraph accelerometer.
  • Child problematic media use
    • Time Frame: Pre-intervention, post-intervention (4 months after pre-intervention), and six-month follow-up (10 months after pre-intervention)
    • Measured by the parent-report via Problematic Media Use Measure (Domoff et al., 2017)
  • Parent-child relationship quality (observed)
    • Time Frame: Pre-intervention, post-intervention (4 months after pre-intervention), and six-month follow-up (10 months after pre-intervention)
    • Dyadic Parent-Child Interaction Coding System-IV (DPICS-IV) will be used. The DPICS provides a reliable measure of parent-child relationship quality (e.g., parents’ child-centered skills, parent and child positive and negative physical and verbal interactions) and parent behavior management skills (e.g., use of contingent reinforcement, effective discipline, child compliance).
  • Parent-child relationship quality (parent report)
    • Time Frame: Pre-intervention, post-intervention (4 months after pre-intervention), and six-month follow-up (10 months after pre-intervention)
    • Scores on the Parent-child Dysfunctional Interaction subscale of the Parenting Stress Index will be used as the parent-report of parent-child relationship quality.
  • Pressure to Eat (parent-report)
    • Time Frame: Pre-intervention, post-intervention (4 months after pre-intervention), and six-month follow-up (10 months after pre-intervention)
    • Scores on the Child Feeding Questionnaire (CFQ)- Pressure to Eat subscale will be calculated.
  • Restriction (parent-report)
    • Time Frame: Pre-intervention, post-intervention (4 months after pre-intervention), and six-month follow-up (10 months after pre-intervention)
    • Scores on the Child Feeding Questionnaire (CFQ)-Restriction subscale will be calculated.
  • Emotional feeding (parent-report)
    • Time Frame: Pre-intervention, post-intervention (4 months after pre-intervention), and six-month follow-up (10 months after pre-intervention)
    • Child Feeding Questionnaire (CFQ)- Pressure to Eat and Restriction subscales and Scores on the Parental Feeding Questionnaire (PFQ)- Emotional Feeding subscale will be calculated.
  • Instrumental feeding (parent-report)
    • Time Frame: Pre-intervention, post-intervention (4 months after pre-intervention), and six-month follow-up (10 months after pre-intervention)
    • Scores on the Parental Feeding Questionnaire (PFQ)- Instrumental Feeding subscale will be calculated.
  • Active Mediation of Television (parent-report)
    • Time Frame: Pre-intervention, post-intervention (4 months after pre-intervention), and six-month follow-up (10 months after pre-intervention)
    • Scores on the Instructive Mediation subscale of the Parental Mediation Scale (Valkenburg et al., 1999) will be calculated.
  • Restrictive Mediation of Television (parent-report)
    • Time Frame: Pre-intervention, post-intervention (4 months after pre-intervention), and six-month follow-up (10 months after pre-intervention)
    • Scores on the Restrictive Mediation subscale of the Parental Mediation Scale (Valkenburg et al., 1999) will be calculated.
  • Social Coviewing of Television (parent-report)
    • Time Frame: Pre-intervention, post-intervention (4 months after pre-intervention), and six-month follow-up (10 months after pre-intervention)
    • Scores on the Social Coviewing subscale of the Parental Mediation Scale (Valkenburg et al., 1999) will be calculated.
  • Location/quantity of screen media in the home (parent-report)
    • Time Frame: Pre-intervention, post-intervention (4 months after pre-intervention), and six-month follow-up (10 months after pre-intervention)
    • Parents will report on the location/quantity of screen media in home and child’s bedroom.
  • Media Parenting Practices (observed)
    • Time Frame: Pre-intervention, post-intervention (4 months after pre-intervention), and six-month follow-up (10 months after pre-intervention)
    • Family mealtime observations will be coded for presence and use of screen media
  • Parent feeding practices (observed)
    • Time Frame: Pre-intervention, post-intervention (4 months after pre-intervention), and six-month follow-up (10 months after pre-intervention)
    • Family mealtime observations will be coded using the Mealtime Interaction Coding System. “Macro” codes will be generated, including Task Accomplishment, Communication, Affect Management, Interpersonal Involvement, Behavior Control, Roles, and Overall Functioning.

Participating in This Clinical Trial

Inclusion Criteria

  • child BMI > 5th percentile
  • child born at 37+ weeks gestation, with no significant neo- or perinatal complications.

Exclusion Criteria

  • Child is experiencing clinical levels of behavior problems
  • History of food allergies or medical problems or medications affecting appetite or weight
  • Non-fluency in English
  • Significant child or parent developmental delay
  • Child currently in State custody
  • Family currently involved with Child Protective Services
  • Caregiver is receiving or has plans to receive other behavioral parenting interventions

Gender Eligibility: All

Minimum Age: 30 Months

Maximum Age: 84 Months

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Central Michigan University
  • Collaborator
    • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Sarah Domoff, PhD, Principal Investigator, Central Michigan University
  • Overall Contact(s)
    • Sarah Domoff, PhD, 989-774-6639, domof1se@cmich.edu

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