Family, Responsibility, Education, Support, and Health for Families With a Child With Autism

NCT05741840 | Active Not Recruiting DMC

• 2 other identifiers: 802230R01HD106991
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this proposed study is to collect initial efficacy data on a telehealth parent-based behavioral program for children with autism and overweight or obesity (PBT-A), compared with health education (HE).

Conditions

Autism Spectrum Disorder; Autism; Obesity, Childhood

Keywords

obesity; treatment; intervention; Autism; behavioral treatment; parent based treatment; children

Outcome Measures

Primary Outcomes (2)

• Child BMIz age and sex adjusted BMI (kg/m^2)

  age and sex adjusted body mass index (BMI) z-score based on the CDC norms

  Change from baseline to month 3, 6, 12, and 18

• Child %BMIp95

  Age and Sex specific percentage of the 95th percentile BMI for age and sex that is more sensitive to change in children with higher weights

  Change from baseline to month 3, 6, 12, and 18

Secondary Outcomes (8)

• Parent Dietary Intake

  Change from baseline to month 6, 12, and 18

• Child Dietary Intake

  Change from baseline to month 6, 12, and 18

• Parent Physical Activity

  Change from baseline to month 6, 12, and 18

• Child Physical Activity

  Change from baseline to month 6, 12, and 18

• Child Mealtime Behaviors

  Change from baseline to month 6, 12, and 18

Study Arms (2)

PBT-A

EXPERIMENTAL

PBT-A includes the elements of family based behavioral treatment for children with obesity, delivered exclusively to a parent via telehealth.

Behavioral: PBT-A

Health Education

ACTIVE COMPARATOR

This program provides information about nutrition, physical activity, sedentary behavior, sleep, emotions, and stress delivered exclusively to a parent via telehealth.

Behavioral: Health Education (HE)

Interventions

PBT-A BEHAVIORAL

PBT-A provides all the elements of family based treatment for children with obesity, including nutrition and physical activity education, behavior therapy skills, and parenting skills.

Also known as: parent based treatment, family based behavioral treatment

PBT-A

Health Education (HE) BEHAVIORAL

The HE arm will provide information about nutrition, physical activity, sedentary behavior, sleep, emotions, and stress.

Health Education

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• A child with OW/OB (\>=85% BMI for age) aged 6-12 years
• Documented (1) community diagnosis or provisional diagnosis of ASD or (2) educational diagnosis of ASD
• The child meets cut-off criteria for autism on the Autism Diagnostic Interview-Revised (ADI-R), as well as overall DSM 5 criteria based on the clinical judgement of an experienced clinician
• The parent who is responsible for food preparation is willing to participate
• The family is willing to commit to attending all treatment and assessment sessions
• Child on a stable regimen of prescription medications which affect appetite or weight (minimum of 3 months)
• Child does not have any medical conditions that limit ability to participate in physical activity for the duration of the study. Parent can participate in physical activity or at least facilitate support of child's completion of recommended physical activity.
• Child and/or parent are not participating in another organized weight control program
• Family owns a device that can facilitate zoom meetings

You may not qualify if:

• Child diagnoses of a serious chronic physical disease (e.g., cystic fibrosis, type 1 diabetes) for which physician supervision of diet and/or exercise is needed
• Child or first degree relative with diagnosis of anorexia or bulimia nervosa based on parent report
• Acute parent psychiatric disorder (e.g., acute suicidality; recent hospitalization; psychosis, moderate or severe alcohol or substance use disorder) that could interfere with treatment.
• Parent is not currently pregnant, lactating or planning to get pregnant during the study duration
• Parent has had bariatric surgery less than 6 months ago and/or is not yet eating solid food or is planning to have bariatric surgery over the study duration
• Child is taking medication for the purpose of weight loss

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• University of California, San Diego: lead

Study Sites (1)

UC San Diego Center for Healthy Eating and Activity Research (CHEAR)

La Jolla, California, 92037, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Pediatric Obesity; Autistic Disorder; Obesity

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kerri Boutelle, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Kerri Boutelle, Professor of Pediatrics, Psychiatry, and Herbert Wertheim School of Public Health and Human Longevity Science

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: February 23, 2023
• Study Start: August 18, 2023
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): January 31, 2028
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

US (1)