RECRUITING

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

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Conditions

Autism Spectrum DisorderObesity, ChildhoodAutismobesitytreatmentinterventionbehavioral treatmentparent based treatmentchildren

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

Telehealth Parent-only Treatment for Youth with Autism Spectrum Disorder and Overweight/obesity

Quick Facts

Study Start:2023-08-18
Study Completion:2028-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05741840

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Years to 12 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. 1. A child with OW/OB (\>=85% BMI for age) aged 6-12 years
  2. 2. Documented (1) community diagnosis or provisional diagnosis of ASD or (2) educational diagnosis of ASD
  3. 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. 4. The parent who is responsible for food preparation is willing to participate
  5. 5. The family is willing to commit to attending all treatment and assessment sessions
  6. 6. Child and parent are on a stable medication regimen (minimum of 3 months)
  7. 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. 8. Child and/or parent are not participating in another organized weight control program
  9. 9. Family owns a device that can facilitate zoom meetings
  1. 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. 2. Child or first degree relative with diagnosis of anorexia or bulimia nervosa based on parent report
  3. 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. 4. Parent is not currently pregnant, lactating or planning to get pregnant during the study duration
  5. 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
  6. 6. Child is taking medication for the purpose of weight loss

Contacts and Locations

Study Contact

Recruitment Coordinator
CONTACT
8558273498
chear@health.ucsd.edu
Kerri Boutelle, Ph.D.
CONTACT
858249-3528
kboutelle@health.ucsd.edu

Principal Investigator

Kerri Boutelle, PhD
PRINCIPAL_INVESTIGATOR
University of California, San Diego

Study Locations (Sites)

UC San Diego Center for Healthy Eating and Activity Research (CHEAR)
La Jolla, California, 92037
United States

Collaborators and Investigators

Sponsor: University of California, San Diego

  • Kerri Boutelle, PhD, PRINCIPAL_INVESTIGATOR, University of California, San Diego

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-18
Study Completion Date2028-03-31

Study Record Updates

Study Start Date2023-08-18
Study Completion Date2028-03-31

Terms related to this study

Keywords Provided by Researchers

  • obesity
  • treatment
  • intervention
  • Autism
  • behavioral treatment
  • parent based treatment
  • children

Additional Relevant MeSH Terms

  • Autism Spectrum Disorder
  • Obesity, Childhood
  • Autism