Family, Responsibility, Education, Support, and Health for Families With a Child With Autism
Running, not enrolling · Not applicable
Conditions studied: Autism Spectrum Disorder, Obesity, Childhood, Autism
In brief
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).
Key facts
- Study ID
- NCT05741840
- Run by
- University of California, San Diego
- People needed
- 140
- Starts
- 2023-08-18
- Expected to finish
- 2028-01-31
- Last updated by the study team
- 2026-05-01
Who can join
Age: 6 and older, up to 12. Sex: any. Healthy volunteers: accepted.
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
Where it is running
- UC San Diego Center for Healthy Eating and Activity Research (CHEAR) — La Jolla, California, United States
Full record on ClinicalTrials.gov
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