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Improving Parent-Child Interactions to Enhance Child Health (PCIT-Health)

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ClinicalTrials.gov Identifier: NCT03982511
Recruitment Status : Recruiting
First Posted : June 11, 2019
Last Update Posted : June 11, 2019
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Michigan
Information provided by (Responsible Party):
Central Michigan University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Child Obesity Behavioral: PCIT-Health Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parent-child dyads will be randomly assigned to PCIT-Health or a waitlist control.
Masking: Single (Outcomes Assessor)
Masking Description: Behavioral observation coders are masked.
Primary Purpose: Prevention
Official Title: Improving Parent-Child Interactions to Prevent Child Obesity in Early Childhood
Actual Study Start Date : May 29, 2019
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PCIT-Health
Participants assigned to the PCIT-Health arm will receive the intervention.
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).
Other Name: PATCH Program

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.



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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.

  5. 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.

  6. 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)

  7. 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).

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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

  18. 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.


Other Outcome Measures:
  1. Child disruptive behaviors (parent report) [ Time Frame: Pre-intervention, post-intervention (4 months after pre-intervention), and six-month follow-up (10 months after pre-intervention) ]
    Eyberg Child Behavior Inventory (ECBI)

  2. Child psychological functioning (parent report) [ Time Frame: Pre-intervention, post-intervention (4 months after pre-intervention), and six-month follow-up (10 months after pre-intervention) ]
    Behavior Assessment System for Children (BASC-3)

  3. Child psychosocial strengths (parent report) [ Time Frame: Pre-intervention, post-intervention (4 months after pre-intervention), and six-month follow-up (10 months after pre-intervention) ]
    Psychosocial Strengths Inventory for Children and Adolescents (PSICA)



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Months to 84 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT03982511


Contacts
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Contact: Sarah Domoff, PhD 989-774-6639 domof1se@cmich.edu
Contact: Larissa Niec, PhD 989-774-6639 niec1L@cmich.edu

Locations
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United States, Michigan
Center for Children, Families, and Communities Recruiting
Mount Pleasant, Michigan, United States, 48858
Contact: Sarah Domoff, PhD    989-774-6639    domof1se@cmich.edu   
Sponsors and Collaborators
Central Michigan University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Michigan
Investigators
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Principal Investigator: Sarah Domoff, PhD Central Michigan University
  Study Documents (Full-Text)

Documents provided by Central Michigan University:
Informed Consent Form  [PDF] February 22, 2019


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Responsible Party: Central Michigan University
ClinicalTrials.gov Identifier: NCT03982511     History of Changes
Other Study ID Numbers: F63376
R21HD093944 ( U.S. NIH Grant/Contract )
First Posted: June 11, 2019    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms