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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Telehealth Parent-only Treatment for Youth With Autism Spectrum Disorder and Overweight/Obesity

Conditions
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Autism Spectrum Disorder, Obesity, Childhood, Autism

Intervention / Treatment
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* Behavioral: PBT-A
* Behavioral: Health Education (HE)


Participation Criteria
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Eligibility Criteria
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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 and parent are on a stable medication regimen (minimum of 3 months) 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 Family owns a device that can facilitate zoom meetings and a device that can facilitate video recording 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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PBT-A<br>PBT-A includes the elements of family based behavioral treatment for children with obesity, delivered exclusively to a parent via telehealth. | Behavioral: PBT-A<br>* 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.<br>* Other names: family based behavioral treatment;|
| Active Comparator: Health Education<br>This program provides information about nutrition, physical activity, sedentary behavior, sleep, emotions, and stress delivered exclusively to a parent via telehealth. | Behavioral: Health Education (HE)<br>* The HE arm will provide information about nutrition, physical activity, sedentary behavior, sleep, emotions, and stress.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child BMIz age and sex adjusted BMI (kg/m^2) | age and sex adjusted body mass index (BMI) z-score based on the CDC norms | Change from baseline to month 3, 6, 12, and 18 | 
| Child %BMIp95 | 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 | Change from baseline to month 3, 6, 12, and 18 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parent Dietary Intake | Block Fat/Sugar/Fruit/Vegetable Screener for adults | Change from baseline to month 6, 12, and 18 | 
| Child Dietary Intake | BLOCK kids food screener completed by parent | Change from baseline to month 6, 12, and 18 | 
| Parent Physical Activity | The International Physical Activity Questionnaire (IPAQ) | Change from baseline to month 6, 12, and 18 | 
| Child Physical Activity | The Children's Physical Activity Questionnaire (C-PAQ) parent proxy | Change from baseline to month 6, 12, and 18 | 
| Child Mealtime Behaviors at home | Measured by video coding of a family meal | Change from baseline to month 6, 12, and 18 | 
| Child Mealtime Behaviors | The Brief Autism Mealtime Behavior Inventory (BAMBI) with scores ranging from 18 to 90 with higher scores indicating greater mealtime problem behaviors | Change from baseline to month 6, 12, and 18 | 
| Parenting style | The Parenting Scale. The total score will range from 1-7 with lower scores representing higher scores representing more dysfunctional parenting | Change from baseline to month 6, 12, and 18 | 
| Parent self-efficacy | The Parenting Sense of Competence Scale (PSOC) - Scores range from 17-102 with higher scores representing higher parenting sense of competence. | Change from baseline to month 6, 12, and 18 | 
| Parent body mass index (BMI) | kg/m^2 | Change from baseline to mid-treatment, months: 3, 6, 12, and 18 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, treatment, intervention, Autism, behavioral treatment, parent based treatment, children