Family, Responsibility, Education, Support, and Health for Families With a Child With Autism (NCT05741840) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Family, Responsibility, Education, Support, and Health for Families With a Child With Autism
United States140 participantsStarted 2023-08-18
Plain-language 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).
Who can participate
Age range6 Years – 12 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
Exclusion criteria
✕. 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
✕
What they're measuring
1
Child BMIz age and sex adjusted BMI (kg/m^2)
Timeframe: Change from baseline to month 3, 6, 12, and 18
2
Child %BMIp95
Timeframe: Change from baseline to month 3, 6, 12, and 18
. 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