FRESH-EF: Families, Responsibility, Education, Support, and Health for Executive Function

Sponsor

University of California, San Diego (Other)

Overall Status

Recruiting

CT.gov ID

NCT05165511

Collaborator

Rady Children's Hospital, San Diego (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Overweight and Obesity Attention-Deficit Hyperactivity Disorder	Behavioral: PBT-EF	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

This is an open-label one-arm pilot study.This is an open-label one-arm pilot study.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Executive Function-Enhanced Parent-Based Behavioral Treatment (PBT-EF) PBT-EF will integrate executive function training with family-based behavioral treatment (FBT) for obesity, the gold-standard behavioral treatment for childhood obesity. PBT-EF will include self-monitoring, calorie reduction, and dietary and physical activity recommendations in addition to planning, organization, and problem-solving skills.	Behavioral: PBT-EF PBT-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.

Arm

Intervention/Treatment

Experimental: Executive Function-Enhanced Parent-Based Behavioral Treatment (PBT-EF)

PBT-EF will integrate executive function training with family-based behavioral treatment (FBT) for obesity, the gold-standard behavioral treatment for childhood obesity. PBT-EF will include self-monitoring, calorie reduction, and dietary and physical activity recommendations in addition to planning, organization, and problem-solving skills.

Behavioral: PBT-EF

PBT-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.

Outcome Measures

Primary Outcome Measures

Feasibility as measured by number of treatment sessions attended [Over the course of 5 months of treatment]
Attendance at Treatment Sessions
Acceptability [At 5 months]
Ratings of usefulness of treatment

Other Outcome Measures

Child body mass index (BMI) [Change from baseline at an average of 5 months and 8 months]
As measured by height and weight (kg/m^2)
Child executive function [Change from baseline at an average of 5 months and 8 months]
Change in executive function measured by Behavior Rating in Executive Functioning - 2 (BRIEF-2). The Global Executive Composite score reflects a standardized t-score with higher scores reflecting greater difficulties in executive function.
Parent executive function [Change from baseline at an average of 5 months and 8 months]
Change in executive function measured by Behavior Rating in Executive Functioning - Adult (BRIEF-A). The Global Executive Composite score reflects a standardized t-score with higher scores reflecting greater difficulties in executive function.
Child behavioral symptoms - Child Behavior Checklist (CBCL) [Change from baseline at an average of 5 months and 8 months]
Change in child behavioral symptoms rated by parents as measured by CBCL. The CBCL is a widely used parent-report questionnaire designed to assess behavioral problems and social competencies of children ages 4-18. It yields standardized T scores and age adjusted scores on internalizing, externalizing, and total behavior difficulties. Higher scores reflect greater behavioral difficulties.
Child behavioral symptoms - Vanderbilt ADHD [Attention Deficit Hyperactivity Disorder] Parent Rating Scale [Change from baseline at an average of 5 months and 8 months]
Change in child behavioral symptoms rated by parents as measured by Vanderbilt ADHD Parent Rating Scale. This scale is a parent-report questionnaire. The parent rates the frequency of 47 behaviors that may indicate behavioral issues. There are also 8 performance questions. Change in total symptoms of the 18 ADHD criteria will be reported. Higher scores reflect greater ADHD symptomatology.

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Child with overweight or obesity (85-99.9% BMI for age),
Child age 8-12,
Child with a diagnosis of ADHD,
A parent willing to participate who can read and understand English at a minimum of a fifth-grade level, able to attend treatment sessions remotely via Zoom on video.

Exclusion Criteria:

Current enrollment in an organized weight control program (parent and child)
Medication specifically prescribed for weight loss (child)
Medical or psychiatric condition that may interfere with treatment participation or that may require physician monitoring of diet and/or exercise (e.g., acute suicidality; psychosis; substance use disorder) (parent and child)
Change in psychotropic medication or other medication that may impact weight or ADHD symptoms during the previous 3 months (child)