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Search / Trial NCT05741840

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

Launched by UNIVERSITY OF CALIFORNIA, SAN DIEGO · Feb 13, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Obesity Treatment Intervention Autism Behavioral Treatment Parent Based Treatment Children

ClinConnect Summary

This clinical trial is looking at a new program designed to help families of children with autism who are also dealing with overweight or obesity. The study will compare a special telehealth program that focuses on behavior changes for parents and children with a standard health education program. The goal is to see how well this new approach works in improving the health and well-being of these families.

To participate, children need to be between 6 and 12 years old, have a diagnosis of autism, and be classified as overweight or obese. Additionally, a parent who is responsible for preparing meals must be willing to join in. Families should be ready to attend all the sessions and have the necessary technology for video meetings. Participants can expect to engage in activities that promote healthier habits while receiving support from researchers and other families. It's important to note that some medical conditions may prevent a child from participating, so families should check that eligibility before signing up.

Gender

ALL

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

About University Of California, San Diego

The University of California, San Diego (UCSD) is a leading academic institution renowned for its commitment to advancing healthcare through innovative research and clinical trials. With a robust focus on translational medicine, UCSD leverages its interdisciplinary approach to explore groundbreaking therapies and interventions across a wide range of medical fields. The university's state-of-the-art facilities and collaboration with top-tier faculty and researchers ensure a comprehensive and ethical framework for conducting clinical trials, ultimately aiming to enhance patient outcomes and contribute to the global body of medical knowledge.

Locations

La Jolla, California, United States

Patients applied

0 patients applied

Trial Officials

Kerri Boutelle, PhD

Principal Investigator

University of California, San Diego

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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