Improving Parent-Child Interactions to Enhance Child Health

NCT03982511 | Completed Results

• 2 other identifiers: F63376R21HD093944
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Child Obesity

Outcome Measures

Primary Outcomes (2)

• Change in Child Body Mass Index (BMI) Percentile

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

  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 Body Mass Index (BMI) Z-score

  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.

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

Secondary Outcomes (18)

• Child Self-regulation (Parent Report)

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

• Child Screen Time

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

• Child Physical Activity

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

• Child Sleep (Parent Report)

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

• Child Sleep (Via Actigraphy)

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

Other Outcomes (3)

• Child Disruptive Behaviors (Parent Report)

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

• Child Psychological Functioning (Parent Report)

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

• Child Psychosocial Strengths (Parent Report)

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

Study Arms (2)

PCIT-Health

EXPERIMENTAL

Participants assigned to the PCIT-Health arm will receive the intervention.

Behavioral: PCIT-Health

Wait list control

NO INTERVENTION

Participants in the wait list control will receive an invitation to participate in the intervention 10 months after baseline data collection.

Interventions

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).

Also known as: PATCH Program

PCIT-Health

Eligibility Criteria

• Age: 30 Months - 84 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Center for Children, Families, and Communities

Mount Pleasant, Michigan, 48858, United States

Location

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The COVID-19 pandemic necessitated changes to our methodology. We changed our intervention into a telehealth format delivered through synchronous video conferencing and other remote distancing strategies. We had to temporarily suspend in-person data collection for participants in the early part of the pandemic, until distancing guidelines could be adhered to safely with personal protective equipment in our clinic.

Results Point of Contact

• Title: Sarah Domoff, PhD
• Organization: Central Michigan University

domof1se@cmich.edu

989-774-6461

Study Officials

• Sarah Domoff, PhD

  Central Michigan University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Behavioral observation coders are masked.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parent-child dyads will be randomly assigned to PCIT-Health or a waitlist control.

Study Record Dates

• First Submitted: June 6, 2019
• First Posted: June 11, 2019
• Study Start: May 29, 2019
• Primary Completion: April 8, 2022
• Study Completion: April 8, 2022
• Last Updated: September 15, 2023
• Results First Posted: September 15, 2023

Record last verified: 2023-02

Locations

US (1)