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Completed

NCT Number: NCT03982511

Improving Parent-Child Interactions to Enhance Child Health

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.

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Key information

Age range

30 month–84 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Children, Families, and Communities

Mount Pleasant, Michigan, 48858, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PCIT-Health

Behavioral

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).

Other names: PATCH Program

Primary outcomes

  1. Change in Child Body Mass Index (BMI) Percentile

    Time frame: Pre-intervention (T1), post-intervention (T2;4 months after pre-intervention), and six-month follow-up (T3;10 months after pre-intervention)

    Change in child BMI percentile will be calculated using standardized anthropometric measurement (height and weight) procedure

  2. Change in Child Body Mass Index (BMI) Z-score

    Time frame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)

    Change in child BMI z-score will be calculated using standardized anthropometric measurement (height and weight) procedure. The z-score is a standard deviation away from the mean, based on the CDC growth charts. Higher z-scores indicate greater weight status. A Z-score of 0 equals the population mean, based on age and sex.

Secondary outcomes

  1. Child Self-regulation (Parent Report)

    Time frame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)

    Emotion Regulation (ER) Checklist, higher scores = greater regulation (better outcome). Mean calculation for total score, with Min=1 to Max=4

  2. Child Screen Time

    Time frame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)

    Parent report of weekly amount of time child spends viewing/using screen media. Scores range from 0-168, with total scores reflecting sum of daily screen time across multiple types of screen media. Higher scores = more screen time.

  3. Child Physical Activity

    Time frame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)

    Measured by Actigraph accelerometer to assess sedentary, moderate, moderate-to-vigorous, and vigorous physical activity (MVPA)

  4. Child Sleep (Parent Report)

    Time frame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)

    Measured by parent report of bedtime, wake time, and naps.

  5. Child Sleep (Via Actigraphy)

    Time frame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)

    Measured by Actigraph accelerometer.

  6. Child Problematic Media Use

    Time frame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)

    Measured by the parent-report via Problematic Media Use Measure (Domoff et al., 2019). Higher scores = greater problematic media use. Total scores = mean of items; Min = 1 to Max = 5.

  7. Parent-child Relationship Quality (Observed)

    Time frame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 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). This outcome reflects behavioral observation of parents' child-centered skills ("DO" skills) during child led play. This is a count variable that can range from 0 displayed skills (min) with no determined maximum. Higher numbers = more skills (better outcome).

  8. Parent-child Relationship Quality (Parent Report)

    Time frame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)

    Scores on the Parent-child Dysfunctional Interaction (PCDI) subscale of the Parenting Stress Index will be used as the parent-report of parent-child relationship quality. Values range from 12 to 60, with higher scores indicating greater dysfunction in (poorer quality of) the parent-child relationship.

  9. Pressure to Eat (Parent-report)

    Time frame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)

    Scores on the Child Feeding Questionnaire (CFQ)- Pressure to Eat subscale will be calculated. This subscale score is a mean, with minimum of 1 and maximum of 5 (higher scores = more pressure to eat, a worse outcome).

  10. Restriction (Parent-report)

    Time frame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)

    Scores on the Child Feeding Questionnaire (CFQ)-Restriction subscale will be calculated. A mean is calculated for this subscale (min = 1 to max = 5). Higher scores = greater restriction of food (poorer outcome).

  11. Emotional Feeding (Parent-report)

    Time frame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)

    Child Feeding Questionnaire (CFQ)- Emotional Feeding subscale will be calculated with a mean of responses to items. Min = 1 to max = 5. Higher scores reflect worse outcome.

  12. Instrumental Feeding (Parent-report)

    Time frame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)

    Scores on the Parental Feeding Questionnaire (PFQ)- Instrumental Feeding subscale will be calculated. Mean calculation of responses, with scores ranging from 1 (min) to 5 (max). Higher scores reflect poorer outcome.

  13. Active Mediation of Television (Parent-report)

    Time frame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)

    Scores on the Instructive Mediation subscale of the Parental Mediation Scale (Valkenburg et al., 1999) will be calculated via sum score of 5 items. Min = 5, max = 20, higher scores = better outcome.

  14. Restrictive Mediation of Television (Parent-report)

    Time frame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)

    Scores on the Restrictive Mediation subscale of the Parental Mediation Scale (Valkenburg et al., 1999) will be calculated via sum score of 5 items. Min = 5, max = 20, higher scores = better outcome.

  15. Social Coviewing of Television (Parent-report)

    Time frame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)

    Scores on the Social Coviewing subscale of the Parental Mediation Scale (Valkenburg et al., 1999) will be calculated via sum score of 5 items. Min = 5, max = 20, higher scores = better outcome.

  16. Location/Quantity of Screen Media in the Home (Parent-report)

    Time frame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)

    Parents will report on the location/quantity of screen media in home and child's bedroom.

  17. Media Parenting Practices (Observed)

    Time frame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)

    Family mealtime observations will be coded for presence and use of screen media (TV, mobile device present, other media present). Coding of the observed behavior is as follows: TV on = 1 if TV is on during mealtime, TV on = 0 if TV is off during mealtime, lower values = better outcomes. Mobile device present = 1 if a mobile device is present, 0 if no mobile device is present, with lower values= better outcomes. Other media present = 1 if other screens are present, 0 if no other screens are present (lower values=better outcomes).

  18. Parent Feeding Practices (Observed)

    Time frame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)

    Family mealtime observations will be coded using a modified version of the Mealtime Interaction Coding System. Aspects of task accomplishment (TA) and behavior control BC) were coded. Scores could range from 1 (min) to 3 (max), with higher scores = better outcomes.

Other outcomes

  1. Child Disruptive Behaviors (Parent Report)

    Time frame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)

    Eyberg Child Behavior Inventory (ECBI); intensity t-score. Higher t-scores indicate poorer outcomes (i.e., greater intensity of behavior problems). T-scores have a mean of 50 (SD = 10). T-scores of 60 or higher indicate clinical significance.

  2. Child Psychological Functioning (Parent Report)

    Time frame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)

    Behavior Assessment System for Children (BASC-3); internalizing symptoms t-score (lower scores better outcome) and adaptive skills t-score (higher scores better outcome). T-scores M = 50, SD = 10, with clinical cut-offs at 70 or above.

  3. Child Psychosocial Strengths (Parent Report)

    Time frame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)

    Psychosocial Strengths Inventory for Children and Adolescents (PSICA). Scores reflect total sum, ranging from 36 (min) to 252 (max); higher scores indicate better outcomes.

Sponsors and collaborators

Lead sponsor

Central Michigan University

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • University of Michigan

Registry information

Official study title

Improving Parent-Child Interactions to Prevent Child Obesity in Early Childhood

Acronym: PCIT-Health

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jun 11, 2019
Registry last updated
Sep 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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