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

Autism Spectrum Disorder Clinical Trial

— FRESH-A  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05741840
• Other study ID #: 802230
• Secondary ID: R01HD106991
• Status: Recruiting
• Phase: N/A
• Start date: August 18, 2023
• Est. completion date: March 31, 2028

Study information

• Verified date: May 2024
• Source: University of California, San Diego
• Contact: Recruitment Coordinator
• Phone: 8558273498
• Email: chear[@]health.ucsd.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: March 31, 2028
• Est. primary completion date: March 31, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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 and parent are 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 and a device that can facilitate video recording

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

Related Conditions & MeSH terms

• Autism
• Autism Spectrum Disorder
• Autistic Disorder
• Obesity
• Obesity, Childhood
• Pediatric Obesity

Intervention

Behavioral:
• PBT-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.
• Health Education (HE)
The HE arm will provide information about nutrition, physical activity, sedentary behavior, sleep, emotions, and stress.

Locations

Country	Name	City	State
United States	UC San Diego Center for Healthy Eating and Activity Research (CHEAR)	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Parent Dietary Intake	Block Fat/Sugar/Fruit/Vegetable Screener for adults	Change from baseline to month 6, 12, and 18
Secondary	Child Dietary Intake	BLOCK kids food screener completed by parent	Change from baseline to month 6, 12, and 18
Secondary	Parent Physical Activity	The International Physical Activity Questionnaire (IPAQ)	Change from baseline to month 6, 12, and 18
Secondary	Child Physical Activity	The Children's Physical Activity Questionnaire (C-PAQ) parent proxy	Change from baseline to month 6, 12, and 18
Secondary	Child Mealtime Behaviors at home	Measured by video coding of a family meal	Change from baseline to month 6, 12, and 18
Secondary	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
Secondary	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
Secondary	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
Secondary	Parent body mass index (BMI)	kg/m^2	Change from baseline to mid-treatment, months: 3, 6, 12, and 18