What is the mechanism of action of this treatment?

Behavioral modification and executive function training are common treatments for ADHD that focus on changing maladaptive behaviors and improving cognitive processes. Behavioral modification uses reinforcement strategies to provide clear guidelines and consistent feedback, helping patients improve self-regulation and reduce symptoms. Executive function training targets skills like working memory, flexible thinking, and self-control, enabling patients to better manage their attention and impulses. These treatments are essential as they address the core deficits in ADHD, offering patients practical tools to manage their symptoms more effectively.

What side effects are associated with this type of intervention?

Behavioral modification and executive function improvement treatments for ADHD, such as Parent-Based Behavioral Treatment Enhanced with Executive-Function Training, generally have minimal physical side effects compared to pharmacological treatments. However, they may lead to emotional or psychological challenges, such as frustration or stress, particularly if the strategies are not well-matched to the individual's needs or if there is a lack of support. Additionally, the effectiveness of these treatments can vary, and some individuals may not experience significant improvements in ADHD symptoms.

What prior FDA approvals exist?

FDA-approved treatments for ADHD include stimulant medications like methylphenidate and non-stimulant options such as guanfacine extended-release. These medications help manage core symptoms of ADHD. Behavioral interventions, including cognitive-behavioral therapy (CBT) and parent-based behavioral training, are also effective, particularly when combined with medication. The Parent-Based Behavioral Treatment Enhanced with Executive-Function Training integrates these approaches to improve both behavioral and executive function skills in children with ADHD.

What other types of research exist?

Promising novel alternatives to PBT-EF for ADHD patients include: 1) The Incredible Years® Parent Training Program, which has shown effectiveness in real-world settings. 2) Behavioral parent training combined with school-based interventions and contingency management, as illustrated in case studies. 3) Technology-enhanced delivery of cognitive-behavioral therapy (CBT) principles, such as web-based training programs. These alternatives offer evidence-based approaches that can be tailored to individual needs.

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Behavioral Intervention

PBT-EF for Obesity and ADHD (FRESH-EF Trial)

N/A

Recruiting

Led By Dawn M Eichen, PhD

Research Sponsored by University of California, San Diego

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline at an average of 5 months and 8 months

Awards & highlights

Summary

This trial is testing a new program that helps parents teach their overweight or obese children with ADHD how to manage their weight and improve their behavior. The program includes special training to help kids focus better and control their impulses. The goal is to make it easier for these children to stick to healthy habits. Parents focused CBT can be considered as a complementary treatment for reducing ADHD symptoms and BMI and increased self-esteem in the obese ADHD children.

Who is the study for?

This trial is for parents who can read and understand English at a fifth-grade level or higher, with children aged 8-12 diagnosed with ADHD and are overweight (85-99.9% BMI for age). They must be able to attend remote sessions via Zoom. Families already in weight control programs or using weight loss meds, and those with certain medical/psychiatric conditions cannot join.

What is being tested?

The study tests a new treatment program called PBT-EF designed for children with both obesity and ADHD. It's an open-label pilot study where all participants receive the same intervention through remote sessions to improve parental support and child's executive function.

What are the potential side effects?

Since this is a behavioral treatment focusing on education and support without medication, no direct side effects like those from drugs are expected. However, stress or discomfort due to lifestyle changes may occur.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline at an average of 5 months and 8 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline at an average of 5 months and 8 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline at an average of 5 months and 8 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability

Feasibility as measured by number of treatment sessions attended

Other study objectives

Child behavioral symptoms - Child Behavior Checklist (CBCL)

Child behavioral symptoms - Vanderbilt ADHD [Attention Deficit Hyperactivity Disorder] Parent Rating Scale

Child body mass index (BMI)

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Executive Function-Enhanced Parent-Based Behavioral Treatment (PBT-EF)Experimental Treatment1 Intervention

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.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Behavioral modification and executive function training are common treatments for ADHD that focus on changing maladaptive behaviors and improving cognitive processes. Behavioral modification uses reinforcement strategies to provide clear guidelines and consistent feedback, helping patients improve self-regulation and reduce symptoms. Executive function training targets skills like working memory, flexible thinking, and self-control, enabling patients to better manage their attention and impulses. These treatments are essential as they address the core deficits in ADHD, offering patients practical tools to manage their symptoms more effectively.

Bibliotherapy as an adjunct to stimulant medication in the treatment of attention-deficit hyperactivity disorder.Behavioural treatment recommendations in clinical practice guidelines for attention-deficit/hyperactivity disorder: a scoping review.

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor

1,157 Previous Clinical Trials

1,571,389 Total Patients Enrolled

1 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)

144 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)

Rady Children's Hospital, San DiegoOTHER

39 Previous Clinical Trials

13,503 Total Patients Enrolled

Dawn M Eichen, PhDPrincipal InvestigatorUniversity of California, San Diego

1 Previous Clinical Trials

39 Total Patients Enrolled

Media Library

PBT-EF (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05165511 — N/A

Attention Deficit Hyperactivity Disorder (ADHD) Research Study Groups: Executive Function-Enhanced Parent-Based Behavioral Treatment (PBT-EF)

Attention Deficit Hyperactivity Disorder (ADHD) Clinical Trial 2023: PBT-EF Highlights & Side Effects. Trial Name: NCT05165511 — N/A

PBT-EF (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05165511 — N/A

~2 spots leftby Dec 2024

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