Improving Parent-Child Interactions to Enhance Child Health

Child Obesity Clinical Trial

— PCIT-Health  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03982511
• Other study ID #: F63376
• Secondary ID: R21HD093944
• Status: Completed
• Phase: N/A
• Start date: May 29, 2019
• Est. completion date: April 8, 2022

Study information

• Verified date: February 2023
• Source: Central Michigan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: April 8, 2022
• Est. primary completion date: April 8, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Months to 84 Months

Eligibility

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

Related Conditions & MeSH terms

• Child Obesity
• Obesity
• Pediatric Obesity

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).

Locations

Country	Name	City	State
United States	Center for Children, Families, and Communities	Mount Pleasant	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
Central Michigan University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Child Disruptive Behaviors (Parent Report)	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.	Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)
Other	Child Psychological Functioning (Parent Report)	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.	Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)
Other	Child Psychosocial Strengths (Parent Report)	Psychosocial Strengths Inventory for Children and Adolescents (PSICA). Scores reflect total sum, ranging from 36 (min) to 252 (max); higher scores indicate better outcomes.	Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)
Primary	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)
Primary	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	Child Self-regulation (Parent Report)	Emotion Regulation (ER) Checklist, higher scores = greater regulation (better outcome). Mean calculation for total score, with Min=1 to Max=4	Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)
Secondary	Child Screen Time	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.	Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)
Secondary	Child Physical Activity	Measured by Actigraph accelerometer to assess sedentary, moderate, moderate-to-vigorous, and vigorous physical activity (MVPA)	Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)
Secondary	Child Sleep (Parent Report)	Measured by parent report of bedtime, wake time, and naps.	Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)
Secondary	Child Sleep (Via Actigraphy)	Measured by Actigraph accelerometer.	Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)
Secondary	Child Problematic Media Use	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.	Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)
Secondary	Parent-child Relationship Quality (Observed)	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).	Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)
Secondary	Parent-child Relationship Quality (Parent Report)	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.	Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)
Secondary	Pressure to Eat (Parent-report)	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).	Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)
Secondary	Restriction (Parent-report)	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).	Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)
Secondary	Emotional Feeding (Parent-report)	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.	Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)
Secondary	Instrumental Feeding (Parent-report)	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.	Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)
Secondary	Active Mediation of Television (Parent-report)	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.	Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)
Secondary	Restrictive Mediation of Television (Parent-report)	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.	Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)
Secondary	Social Coviewing of Television (Parent-report)	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.	Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)
Secondary	Location/Quantity of Screen Media in the Home (Parent-report)	Parents will report on the location/quantity of screen media in home and child's bedroom.	Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)
Secondary	Media Parenting Practices (Observed)	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).	Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)
Secondary	Parent Feeding Practices (Observed)	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.	Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)