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

NCT ID: NCT05741840

Last Updated: 2025-09-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-18
• Study Completion Date: 2028-03-31

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).

Detailed Description

The study will compare the efficacy of PBT-A and health education program delivered via telehealth to parents on child weight management. Investigators will provide 6 months of a group program (PBT-A or HE) and will follow participants for 12-months post-treatment (total time = 18 months). Investigators will recruit parents of children diagnosed with autism and overweight or obesity. Assessments will occur at 5 timepoints: baseline, mid-treatment, post-treatment, 6-month and 12-month follow-up. Assessments will include anthropometry for both parent and child. Parent will also provide information regarding autism diagnosis and characteristics, eating behaviors, and parenting relationship measures. This program of research has the potential to advance the standard of practice for children with autism and overweight or obesity by developing tailored interventions which can be easily disseminated.

Conditions

Autism Spectrum Disorder; Obesity, Childhood; Autism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

PBT-A

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

Group Type: EXPERIMENTAL

PBT-A

Intervention Type: 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.

Health Education

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

Group Type: ACTIVE_COMPARATOR

Health Education (HE)

Intervention Type: BEHAVIORAL

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

Interventions

PBT-A

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.

Intervention Type: BEHAVIORAL

Health Education (HE)

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

Intervention Type: BEHAVIORAL

Other Intervention Names

parent based treatment; family based behavioral treatment

Eligibility Criteria

Inclusion Criteria

1. A child with OW/OB (>=85% BMI for age) aged 6-12 years

2. Documented (1) community diagnosis or provisional diagnosis of ASD or (2) educational diagnosis of ASD

3. 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

4. The parent who is responsible for food preparation is willing to participate

5. The family is willing to commit to attending all treatment and assessment sessions

6. Child on a stable medication regimen (minimum of 3 months)

7. 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.

8. Child and/or parent are not participating in another organized weight control program

9. Family owns a device that can facilitate zoom meetings

Exclusion Criteria

1. 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

2. Child or first degree relative with diagnosis of anorexia or bulimia nervosa based on parent report

3. Acute parent psychiatric disorder (e.g., acute suicidality; recent hospitalization; psychosis, moderate or severe alcohol or substance use disorder) that could interfere with treatment.

4. Parent is not currently pregnant, lactating or planning to get pregnant during the study duration

5. 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

6. Child is taking medication for the purpose of weight loss

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Kerri Boutelle

Kerri Boutelle, Professor of Pediatrics, Psychiatry, and Herbert Wertheim School of Public Health and Human Longevity Science

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kerri Boutelle, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

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

La Jolla, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Recruitment Coordinator

Role: CONTACT

chear@health.ucsd.edu

8558273498

Kerri Boutelle, Ph.D.

Role: CONTACT

kboutelle@health.ucsd.edu

858249-3528

Facility Contacts

Kerri Boutelle, Ph.D.

Role: primary

kboutelle@health.ucsd.edu

8582493528

Other Identifiers

R01HD106991

Identifier Type: NIH

Identifier Source: secondary_id

View Link

802230

Identifier Type: -

Identifier Source: org_study_id