Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT05165511

Families, Responsibility, Education, Support, and Health for Executive Function

Executive Function Enhanced Parent-Based Treatment for Children With ADHD and Overweight or Obesity

Status
Withdrawn
Phase
N/A
Study type
Interventional
Enrollment
0 (actual)
Sponsor
University of California, San Diego · Academic / Other
Sex
All
Age
8 Years – 12 Years
Healthy volunteers
Not accepted

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 (OW/OB), family-based behavioral treatment (FBT), results in sustained weight loss for only 1/3 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 OW/OB in children with ADHD; thus, children with OW/OB 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 OW/OB 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 OW/OB in children with ADHD, and could inform clinical decision making regarding obesity treatment.

Conditions

Interventions

TypeNameDescription
BEHAVIORALPBT-EFPBT-EF will be delivered to parents only. Parents will be taught general behavioral weight loss skills to apply to their child and themselves including decreasing caloric intake and increasing physical activity, self-monitoring, and goal setting. Additionally, parents will learn compensatory strategies surrounding organization, habit learning, planning, and problem-solving to generalize FBT skills to real-world behaviors (e.g., self-monitoring of food intake). Each session will include interactive exercises to help train an aspect of EF. Skills taught will be presented to be practiced with real-world applications.

Timeline

Start date
2022-07-26
Primary completion
2025-05-01
Completion
2025-05-01
First posted
2021-12-21
Last updated
2026-03-04

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05165511. Inclusion in this directory is not an endorsement.