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 range
6 Years – 12 Years
Sex
ALL
See this in plain English?
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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
. 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