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

Central Michigan University

Status: Completed

Conditions: Child Obesity

Treatments: Behavioral: PCIT-Health

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03982511

R21HD093944 (U.S. NIH Grant/Contract)

F63376

Details and patient eligibility

About

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.

Enrollment: 63 patients

Sex: All

Ages: 30 to 84 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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63 participants in 2 patient groups

PCIT-Health

Experimental group

Description:

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

Treatment:

Behavioral: PCIT-Health

Wait list control

No Intervention group

Description:

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