Autism, Autism Spectrum Disorder, Obesity, Childhood
Conditions
Keywords
obesity, treatment, intervention, Autism, behavioral treatment, parent based treatment, children
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.
Interventions
BEHAVIORALPBT-A
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.
BEHAVIORALHealth Education (HE)
The HE arm will provide information about nutrition, physical activity, sedentary behavior, sleep, emotions, and stress.
Sponsors
University of California, San Diego
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 %BMIp95 | Change 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parent Dietary Intake | Change from baseline to month 6, 12, and 18 | Block Fat/Sugar/Fruit/Vegetable Screener for adults |
| Child Dietary Intake | Change from baseline to month 6, 12, and 18 | BLOCK kids food screener completed by parent |
| Parent Physical Activity | Change from baseline to month 6, 12, and 18 | The International Physical Activity Questionnaire (IPAQ) |
| Child Physical Activity | Change from baseline to month 6, 12, and 18 | The Children's Physical Activity Questionnaire (C-PAQ) parent proxy |
| Child Mealtime Behaviors | Change from baseline to month 6, 12, and 18 | The Brief Autism Mealtime Behavior Inventory (BAMBI) with scores ranging from 18 to 90 with higher scores indicating greater mealtime problem behaviors |
| Parent self-efficacy | Change from baseline to month 6, 12, and 18 | The Parenting Sense of Competence Scale (PSOC) - Scores range from 17-102 with higher scores representing higher parenting sense of competence. |
| Parent body mass index (BMI) | Change from baseline to mid-treatment, months: 3, 6, 12, and 18 | kg/m\^2 |
| Parenting as measured by the Alabama Parenting Questionnaire (APQ) | Change from baseline to month 6, 12, and 18 | Parents will self-report parenting behaviors via the APQ across 5 domains: 1) positive involvement with children, 2) supervision and monitoring, 3) use of positive discipline techniques, 4) consistency in the use of such discipline, and 5) use of corporal punishment. Higher scores indicate greater frequency of engagement with that particular parenting domain. Scores range from 1-5. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKerri Boutelle, PhD
University of California, San Diego
Outcome results
None listed