Telehealth Program for Autism

(FRESH-A Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Kerri Boutelle, PhD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of California, San Diego

Must not be taking: Weight loss medications

Disqualifiers: Chronic physical disease, Anorexia, Bulimia, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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).

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 data supports the effectiveness of the treatment Telehealth Parent-Based Behavioral Program for children with autism and overweight or obesity?

Research shows that parent-based behavioral programs can help children with autism and weight issues lose weight, and telehealth delivery of similar programs has been effective for children with autism. Parents and children in these programs have reported weight loss and high satisfaction, indicating the potential effectiveness of this telehealth approach. ^{1 2 3 4 5}

How is the Telehealth Program for Autism treatment different from other treatments for autism?

The Telehealth Program for Autism, using the PBT-A treatment, is unique because it combines parent-based behavioral training with telehealth to address both autism and weight issues in children, making it more accessible and potentially cost-effective compared to traditional in-person therapies. ^{1 6 7 8 9}

Research Team

Kerri Boutelle, PhD

Principal Investigator

University of California, San Diego

Eligibility Criteria

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

My child and I have been on a stable medication regimen for at least 3 months.

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.

Trial Timeline

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

Treatment Details

Interventions

• HE (Behavioral Intervention)
• PBT-A (Behavioral Intervention)

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.

Participant Groups

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+

Dr. Christopher Longhurst

University of California, San Diego

Chief Medical Officer since 2021

MD and MS in Medical Informatics from UC Davis

Patty Maysent

University of California, San Diego

Chief Executive Officer since 2016

MBA from Stanford University

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

Collaborator

Trials

2,103

Recruited

2,760,000+

Dr. Diana W. Bianchi

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

Chief Executive Officer since 2016

MD from Stanford University

Dr. Alison Cernich

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

Chief Medical Officer since 2020

PhD in Clinical Psychology from University of Maryland

Findings from Research

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 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]

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]

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]

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]

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]

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]

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]

References

1. United States 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. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Tele-PCIT: Initial Examination of Internet Delivered PCIT for Young Children with Autism. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Feasibility of a Structured, Multidisciplinary Intervention for Weight Management in Children With Autism Spectrum Disorder. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Weight Management Outcomes of Youth with Autism Spectrum Disorder Seeking Treatment from a Multidisciplinary Team. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Behavioral Parent Training Engagement Among Young Children With Autism Spectrum Disorder. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Telehealth and Autism: Treating Challenging Behavior at Lower Cost. [2022]

7. United States 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. [2022]

8. United States 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. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Behavioral Parent Training via Telehealth for Autistic Children: Further Exploration of Feasibility During the COVID-19 Pandemic. [2023]