Clinical trial NCT05741840: Family, Responsibility, Education, Support, and Health for Families With a Child With Autism
Official title: Telehealth Parent-only Treatment for Youth With Autism Spectrum Disorder and Overweight/Obesity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Obesity, Childhood
Autism
Keywords: obesity
treatment
intervention
Autism
behavioral treatment
parent based treatment
children
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2023-02-23
Enrollment: 150
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed 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.

Eligibility 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 medication regimen (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

Primary outcomes:
measure: Child BMIz age and sex adjusted BMI (kg/m^2)
timeFrame: Change from baseline to month 3, 6, 12, and 18
measure: Child %BMIp95
timeFrame: Change from baseline to month 3, 6, 12, and 18
Secondary outcomes:
measure: Parent Dietary Intake
timeFrame: Change from baseline to month 6, 12, and 18
measure: Child Dietary Intake
timeFrame: Change from baseline to month 6, 12, and 18
measure: Parent Physical Activity
timeFrame: Change from baseline to month 6, 12, and 18
measure: Child Physical Activity
timeFrame: Change from baseline to month 6, 12, and 18
measure: Child Mealtime Behaviors
timeFrame: Change from baseline to month 6, 12, and 18
measure: Parent self-efficacy
timeFrame: Change from baseline to month 6, 12, and 18
measure: Parent body mass index (BMI)
timeFrame: Change from baseline to mid-treatment, months: 3, 6, 12, and 18
measure: Parenting as measured by the Alabama Parenting Questionnaire (APQ)
timeFrame: Change from baseline to month 6, 12, and 18
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UC San Diego Center for Healthy Eating and Activity Research (CHEAR)
state: California
Study officials:
affiliation: University of California, San Diego
name: Kerri Boutelle, PhD
role: PRINCIPAL_INVESTIGATOR
References: