Family, Responsibility, Education, Support, and Health for Families With a Child With Autism (FRESH-A)

University of California San Diego

Status: Enrolling

Conditions: Autism Spectrum Disorder; Obesity, Childhood; Autism

Treatments: Behavioral: Health Education (HE); Behavioral: PBT-A

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05741840

802230

R01HD106991 (U.S. NIH Grant/Contract)

Details and patient eligibility

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).

Full description

The study will compare the efficacy of PBT-A and health education program delivered via telehealth to parents on child weight management. Investigators will provide 6 months of a group program (PBT-A or HE) and will follow participants for 12-months post-treatment (total time = 18 months). Investigators will recruit parents of children diagnosed with autism and overweight or obesity. Assessments will occur at 5 timepoints: baseline, mid-treatment, post-treatment, 6-month and 12-month follow-up. Assessments will include anthropometry for both parent and child. Parent will also provide information regarding autism diagnosis and characteristics, eating behaviors, and parenting relationship measures. This program of research has the potential to advance the standard of practice for children with autism and overweight or obesity by developing tailored interventions which can be easily disseminated.

Enrollment: 150 estimated patients

Sex: All

Ages: 6 to 12 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups

PBT-A

Experimental group

Description:

PBT-A includes the elements of family based behavioral treatment for children with obesity, delivered exclusively to a parent via telehealth.

Treatment:

Behavioral: PBT-A

Health Education

Active Comparator group

Description:

This program provides information about nutrition, physical activity, sedentary behavior, sleep, emotions, and stress delivered exclusively to a parent via telehealth.

Treatment:

Behavioral: Health Education (HE)