Clinical trial

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

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT05741840

Active, not recruitingNot applicableInterventional

What this study is about

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).

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age6 Years to 12 Years
SexAll
Healthy volunteersAccepted
ConditionAutism Spectrum Disorder, Obesity, Childhood, Autism

Full registry 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 regimen of prescription medications which affect appetite or weight (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

Treatments and study arms

PBT-A

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 (HE)

Behavioral

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

Primary outcomes

Child BMIz age and sex adjusted BMI (kg/m^2)Change from baseline to month 3, 6, 12, and 18

age and sex adjusted body mass index (BMI) z-score based on the CDC norms

Child %BMIp95Change from baseline to month 3, 6, 12, and 18

Age and Sex specific percentage of the 95th percentile BMI for age and sex that is more sensitive to change in children with higher weights

Study locations

1 locations were listed when this page was built. The first 40 are shown.

UC San Diego Center for Healthy Eating and Activity Research (CHEAR)🇺🇸 La Jolla, California, United States