PBT-A for Autism

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
UC San Diego Center for Healthy Eating and Activity Research (CHEAR), La Jolla, CAAutism+3 MorePBT-A - Behavioral
Eligibility
6 - 12
All Sexes
What conditions do you have?
Select

Study Summary

This trial will study if a telehealth program can help children with autism & obesity/overweight better than health education.

Eligible Conditions
  • Autism
  • Childhood Obesity
  • Autism Spectrum Disorder (ASD)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 9 Secondary · Reporting Duration: Change from baseline to month 3, 6, 12, and 18

Change from baseline to mid-treatment, months: 3, 6, 12, and 18
Parent body mass index (BMI)
Month 3
Child %BMIp95
Child BMIz age and sex adjusted BMI (kg/m^2)
Month 6
Child Dietary Intake
Child Mealtime Behaviors
Child Mealtime Behaviors at home
Child Physical Activity
Parent Dietary Intake
Parent Physical Activity
Parent self-efficacy
Parenting style

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Health Education
1 of 2
PBT-A
1 of 2

Active Control

Experimental Treatment

150 Total Participants · 2 Treatment Groups

Primary Treatment: PBT-A · No Placebo Group · N/A

PBT-A
Behavioral
Experimental Group · 1 Intervention: PBT-A · Intervention Types: Behavioral
Health Education
Behavioral
ActiveComparator Group · 1 Intervention: Health Education (HE) · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: change from baseline to month 3, 6, 12, and 18

Who is running the clinical trial?

University of California, San DiegoLead Sponsor
1,034 Previous Clinical Trials
1,821,543 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,840 Previous Clinical Trials
2,162,670 Total Patients Enrolled
Kerri Boutelle, PhDPrincipal InvestigatorUniversity of California, San Diego
5 Previous Clinical Trials
639 Total Patients Enrolled

Eligibility Criteria

Age 6 - 12 · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have been diagnosed with autism by a doctor in your community.

Frequently Asked Questions

Is the study cohort open to senior citizens above a certain age?

"This medical study is enrolling children aged between 6 and 12 years old." - Anonymous Online Contributor

Unverified Answer

Is enrollment open for this medical research study?

"This clinical trial is enrolling a cohort of 150 individuals aged between 6 and 12 who have been diagnosed with autism." - Anonymous Online Contributor

Unverified Answer

Is enrollment open for this clinical trial presently?

"It appears that the clinical trial in question is no longer recruiting patients. The posting was initially made on June 1st, 2023 and the page was last edited on February 23rd of the same year. However, many other studies are still enrolling participants at this time with a total of 1297 trials currently underway." - Anonymous Online Contributor

Unverified Answer

What beneficial insights are expected from this research?

"The primary metric of this trial, assessed at month 3, 6, 12 and 18 post-baseline will be the Child BMIz age and sex adjusted BMI (kg/m^2). Other measurements monitored throughout the study include Child Dietary Intake as recorded by a BLOCK kids food screener completed by a parent or guardian, Parent Physical Activity determined through an International Physical Activity Questionnaire (IPAQ), and lastly Child Physical Activity measured with The Children's Physical Activity Questionnaire (C-PAQ) using data provided from parental proxies." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.