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Behavioral Intervention
Telehealth Program for Autism (FRESH-A Trial)
N/A
Recruiting
Led By Kerri Boutelle, PhD
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to month 3, 6, 12, and 18
Awards & highlights
No Placebo-Only Group
Summary
This trial will study if a telehealth program can help children with autism & obesity/overweight better than health education.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves behavior modification and education programs rather than medication, traditional side effects are not expected. However, participants may experience stress or frustration related to lifestyle changes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline to month 3, 6, 12, and 18
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to month 3, 6, 12, and 18
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Child %BMIp95
Child BMIz age and sex adjusted BMI (kg/m^2)
Secondary study objectives
Child Dietary Intake
Child Mealtime Behaviors
Child Mealtime Behaviors at home
+6 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: PBT-AExperimental Treatment1 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 EducationActive Control1 Intervention
This program provides information about nutrition, physical activity, sedentary behavior, sleep, emotions, and stress delivered exclusively to a parent via telehealth.
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Who is running the clinical trial?
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,055 Previous Clinical Trials
2,731,723 Total Patients Enrolled
36 Trials studying Autism Spectrum Disorder
9,901 Patients Enrolled for Autism Spectrum Disorder
University of California, San DiegoLead Sponsor
1,180 Previous Clinical Trials
1,574,897 Total Patients Enrolled
9 Trials studying Autism Spectrum Disorder
14,795 Patients Enrolled for Autism Spectrum Disorder
Kerri Boutelle, PhDPrincipal InvestigatorUniversity of California, San Diego
5 Previous Clinical Trials
639 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility 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.My child and I have been on a stable medication regimen for at least 3 months.I have been diagnosed with ASD by a professional or educational institution.The person who cooks in my family is willing to join.My child or a close relative has been diagnosed with anorexia or bulimia.My family and I are committed to attending all treatment and assessment sessions.My child is overweight or obese for their age, between 6-12 years old.Neither I nor my child are in another weight control program.
Research Study Groups:
This trial has the following groups:- Group 1: Health Education
- Group 2: PBT-A
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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