Telehealth Program for Autism

(FRESH-A Trial)

Overseen By Kerri Boutelle, Ph.D.

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Diego

Must not be taking: Weight loss medications

Disqualifiers: Chronic physical disease, Anorexia, Bulimia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 6 months

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a telehealth program designed to help parents manage the behaviors and weight of children with autism and obesity. The goal is to determine if the parent-focused program, known as PBT-A (Parent-Based Behavioral Program for Children with Autism and Overweight or Obesity), is more effective than general health education in improving children's health. Families with children aged 6-12 years who have autism and are overweight, and who are not currently in another weight control program, might be a good fit. As an unphased trial, this study offers families the chance to contribute to innovative research that could improve health outcomes for children with autism and obesity.

Will I have to stop taking my current medications?

The trial requires that both the child and parent are on a stable medication regimen for at least 3 months, so you will not need to stop taking your current medications.

What prior data suggests that this telehealth program is safe for children with autism?

Research has shown that the PBT-A program, a telehealth treatment for children with autism who are overweight or obese, has been well-received. In a small study involving parents of 20 children, the program proved practical and acceptable. Some children even reached a healthy weight. The findings indicate that the treatment is safe, with no major side effects reported. Although the research remains in the early stages, the results so far are promising regarding safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Telehealth Program for Autism because it aims to deliver family-based behavioral treatment for children with obesity, specifically through telehealth. Unlike traditional in-person interventions, this study explores the feasibility and effectiveness of delivering comprehensive health education remotely, focusing on aspects like nutrition, physical activity, and emotional well-being. By engaging parents directly via telehealth, this approach could make support more accessible and convenient for families, potentially reaching those who might not have easy access to specialized care. This innovative delivery method could transform how therapeutic support is provided, offering flexibility and extending the reach of effective treatments in managing autism-related challenges.

What evidence suggests that this trial's treatments could be effective for autism?

Research has shown that the PBT-A (Parent-Based Treatment for Autism) program, a treatment option in this trial, might help manage weight in children with autism. A small initial study found that this method works well and is well-received, indicating that parents can successfully assist their children with weight management through online sessions. The program emphasizes family involvement, which is key to changing behaviors. While more data is being collected on its effectiveness, early findings suggest that when parents use these behavioral strategies, it can lead to better weight outcomes for their children. This program aims to equip parents with the tools needed to support their children's health from home. ^{2 3 6 7 8}

Who Is on the Research Team?

Kerri Boutelle, PhD

Principal Investigator

University of California, San Diego

Are You a Good Fit for This Trial?

This trial is for families with a child aged 6-12 who has autism and is overweight, with no medical conditions limiting physical activity. The family must have technology for telehealth sessions, the parent responsible for meals must participate, and they should commit to all sessions without being in another weight control program.

Inclusion Criteria

The child meets cut-off criteria for autism on the Autism Diagnostic Interview-Revised (ADI-R) and overall DSM 5 criteria based on clinical judgement

Parent can participate in physical activity or at least facilitate support of child's completion of recommended physical activity

Family owns a device that can facilitate zoom meetings and a device that can facilitate video recording

Exclusion Criteria

My parent had weight loss surgery less than 6 months ago or isn't eating solid food yet.

My parent does not have a psychiatric disorder that could affect my treatment.

My child has a chronic illness like cystic fibrosis or type 1 diabetes that requires a doctor's supervision for diet or exercise.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the PBT-A or Health Education program via telehealth for 6 months

6 months

Telehealth sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Assessments at 6-month and 12-month follow-up

What Are the Treatments Tested in This Trial?

Interventions

• HE
• PBT-A

Trial Overview The study tests a telehealth-based behavioral program (PBT-A) against health education (HE) to help children with autism manage their weight. It aims to see if PBT-A can be effective when delivered through remote means like video calls.

How Is the Trial Designed?

Group I: PBT-A Experimental Treatment 1 Intervention

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

Group II: Health Education Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

A systematic review of 55 studies indicates that telehealth services for children and adolescents with autism spectrum disorder (ASD) can be as effective, or even more effective, than traditional face-to-face services for assessments and interventions.

Telehealth has been successfully used for various services, including diagnostic assessments and applied behavior analysis, highlighting its potential to improve access to necessary support for families, although future research should address the challenges of digital access.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telehealth and Autism Prior to and in the Age of COVID-19: A Systematic and Critical Review of the Last Decade. Ellison, KS., Guidry, J., Picou, P., et al.[2022]

The CHANGE program, a structured multidisciplinary treatment for overweight or obese children with autism spectrum disorder (ASD), showed preliminary feasibility in a 16-week study involving 10 participants aged 5-12, with high parental adherence to the program.

Despite moderate attendance (57%), all participants expressed a willingness to recommend the program, indicating positive reception and potential for further development in addressing obesity in children with ASD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a Structured, Multidisciplinary Intervention for Weight Management in Children With Autism Spectrum Disorder. Burrell, TL., Sharp, WG., Criado, KK., et al.[2021]

A pilot study involving 20 children with autism spectrum disorder (ASD) showed that a parent-based weight-loss treatment (PBT-ASD) was feasible and acceptable, leading to weight loss for both children and parents after 16 sessions.

The intervention also resulted in increased physical activity and vegetable consumption among the children, indicating positive behavioral changes associated with the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Study Investigating the Feasibility and Acceptability of a Parent-Only Behavioral Weight-Loss Treatment for Children with Autism Spectrum Disorder. Matheson, BE., Drahota, A., Boutelle, KN.[2020]

In a study of 74 youth with Autism Spectrum Disorder (ASD) undergoing a year-long weight management program, factors such as higher baseline BMI, use of medications, and absence of sleep difficulties were linked to greater reductions in BMI.

These findings suggest that addressing sleep issues and considering medication use may enhance the effectiveness of obesity treatments for youth with ASD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight Management Outcomes of Youth with Autism Spectrum Disorder Seeking Treatment from a Multidisciplinary Team. Killian, HJ., Pallotto, IK., Sweeney, BR., et al.[2022]

The PLANE program aims to improve health outcomes for children on the autism spectrum and their caregivers through a 12-month telehealth intervention focused on physical activity and nutrition education, enrolling 180 participants.

The study will assess various outcomes, including rates of overweight/obesity, physical activity, nutrition, and quality of life, while also evaluating the feasibility of delivering this intervention virtually.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting physical activity participation and nutrition education through a telehealth intervention for children on the autism spectrum and their caregivers. Ketcheson, LR., Pitchford, EA.[2022]

In a study involving 20 children aged 2-6 with autism spectrum disorder (ASD), Telehealth delivery of Parent-Child Interaction Therapy (Tele-PCIT) showed significant improvements in both parenting practices and child behavior after 10 sessions, with 80% of participants completing the treatment.

Parents reported reduced stress and negative parenting behaviors, alongside increased use of positive parenting skills, while children exhibited decreased externalizing behavior problems, with these benefits maintained at a 3-month follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tele-PCIT: Initial Examination of Internet Delivered PCIT for Young Children with Autism. Ros-DeMarize, R., Boan, A., Bradley, C., et al.[2023]

A study involving 107 young children with autism or developmental disabilities found that all three service delivery models (in-home therapy, clinic-based telehealth, and home-based telehealth) effectively reduced challenging behaviors by over 90% after treatment, indicating the efficacy of parent-implemented applied behavior analysis (ABA).

Home-based telehealth was the most cost-effective method for delivering ABA training, significantly reducing treatment costs compared to in-home therapy, which suggests that telehealth can improve access to effective behavioral treatments for families regardless of their location.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telehealth and Autism: Treating Challenging Behavior at Lower Cost. Lindgren, S., Wacker, D., Suess, A., et al.[2022]

About 25% of young children with Autism Spectrum Disorder (ASD) in the study had disruptive behavior problems that could benefit from Behavioral Parent Training (BPT), but only one-third of these families were referred to such programs, highlighting a gap in access to necessary interventions.

Caregivers expressed a strong interest in BPT, especially in formats like telehealth and group sessions, indicating that tailoring delivery methods to parent and child characteristics could enhance engagement and satisfaction with the therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral Parent Training Engagement Among Young Children With Autism Spectrum Disorder. Ros-DeMarize, R., Klein, J., Carpenter, LA.[2023]

A feasibility trial involving 14 parents of autistic children showed that behavioral parent training (BPT) can be effectively delivered via telehealth, maintaining high fidelity in implementation and receiving positive feedback from participants.

The telehealth format of BPT demonstrated promise in reducing disruptive behaviors in autistic children, improving their adaptive skills, and decreasing parental stress, suggesting it could be a valuable alternative to traditional in-person training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral Parent Training via Telehealth for Autistic Children: Further Exploration of Feasibility During the COVID-19 Pandemic. Martin, RJ., Crowley-Zalaket, J., Gould, K., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05741840

Study Details | NCT05741840 | Family, Responsibility, ... The objective of this proposed study is to collect initial efficacy data on a telehealth parent-based behavioral program for children with autism and ...

2. clinicaltrials.ucsd.edu clinicaltrials.ucsd.edu/trial/NCT05741840

UCSD Autism Trial → Family, Responsibility, Education ... The study will compare the efficacy of PBT-A and health education program delivered via telehealth to parents on child weight management. Investigators will ...

3. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT05741840?term=autistic+disorder

Family, Responsibility, Education, Support, and Health for ... This may be indicated by a specific age or the following age groups: The age groups are: Child (birth-17); Adult (18-64); Older Adult (65+) ... A measure of all ...

4. reporter.nih.gov reporter.nih.gov/project-details/10862879

RePORT ⟩ RePORTER We're sorry but RePORTER doesn't work properly without JavaScript enabled. Please enable it to continue.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6943914/

A Pilot Study Investigating the Feasibility and Acceptability ... A parent-based weight-loss treatment for children with ASD (PBT-ASD) was developed. A pilot study was conducted to test the initial efficacy, feasibility, and ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05741840

Family, Responsibility, Education, Support, and Health for ... Investigators will recruit parents of children diagnosed with autism and overweight or obesity. ... age and sex adjusted body mass index (BMI) z-score based on ...

7. escholarship.org escholarship.org/uc/item/4j8261n4

A Pilot Study Investigating the Feasibility and Acceptability ... A pilot study was conducted to test the initial efficacy, feasibility, and acceptability of this intervention. Parents of 20 children with ASD and overweight/ ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12053569/

Parenting Training Plus Behavioral Treatment for Children ... Families were included in the study if the child was aged 7 to 12 years and had overweight (BMI ≥85th to <95th percentile) or obesity (BMI ≥95th ...