Ignite Creation Date:
2024-05-06 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 2:20 PM
Study NCT ID:
NCT05165511
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2021-12-07
Brief Title:
Families Responsibility Education Support and Health for Executive Function
Sponsor:
University of California San Diego
Organization:
University of California San Diego
Study Overview
Official Title:
Executive Function Enhanced Parent-Based Treatment for Children With ADHD and Overweight or Obesity
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FRESH-EF
Brief Summary:
The pilot study will be a one group open-label treatment program and will be used to refine a parent-based behavioral treatment enhanced with executive-function training PBT-EF for children with comorbid overweight or obesity and Attention-Deficit Hyperactivity Disorder ADHD
Detailed Description:
The currently recommended treatment for children with overweight or obesity OWOB family-based behavioral treatment FBT results in sustained weight loss for only 13 of children Attention-Deficit Hyperactivity Disorder ADHD is one of the most common neurobehavioral disorders in children and is characterized by difficulties in Executive Function EF Substantial research suggests higher rates of OWOB in children with ADHD thus children with OWOB and ADHD are likely to have greater difficulties with EF and achieving success in FBT The proposed study aims to develop a parent-based behavioral treatment enhanced with EF training PBT-EF to improve treatment outcomes for children with comorbid OWOB and ADHD The treatment will be administered to parents in 18 group sessions over 5 months Parents and children will be assessed at baseline post-treatment and 3-month follow-up Assessments will include body mass index BMI assessments of executive function and behavioral questionnaires This study could provide a novel model to treat OWOB in children with ADHD and could inform clinical decision making regarding obesity treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None