What side effects are associated with this type of intervention?

Common treatments for ADHD include stimulant medications like methylphenidate and amphetamines, which can cause side effects such as insomnia, decreased appetite, weight loss, increased heart rate, and potential for substance misuse. Non-pharmacological treatments like Central Executive Training (CET) and Behavioral Parent Training (BPT) generally have fewer side effects. CET may cause temporary frustration or fatigue due to the cognitive demands, while BPT may lead to initial resistance or stress as family dynamics are adjusted. Overall, non-pharmacological treatments are considered safer but may require more time and effort to see significant improvements.

What prior FDA approvals exist?

FDA-approved treatments for ADHD primarily include stimulant medications such as methylphenidate and amphetamines, as well as non-stimulant options like atomoxetine and alpha-2-adrenergic agonists. While Behavioral Parent Training (BPT) and Central Executive Training (CET) are not FDA-approved, they are evidence-based interventions that improve family functioning and working memory, respectively, and can complement pharmacological treatments.

What other types of research exist?

Promising novel alternatives to CET and BPT for ADHD include mindfulness training for children and mindful parenting for their parents, which have shown effectiveness in reducing ADHD and ODD symptoms. Additionally, computerized working memory training has demonstrated improvements in working memory, response inhibition, and reasoning, along with reductions in inattentive symptoms. These interventions offer complementary benefits and can be considered as part of a comprehensive treatment plan for ADHD.

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Behavioural Intervention

CET + BPT for ADHD

N/A

Recruiting

Research Sponsored by Florida State University

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 up to 5 years

Awards & highlights

Summary

This trial combines a computer program to help kids with ADHD improve their memory and focus with a training program for parents to better manage their child's behavior. The goal is to see if using both treatments together can provide greater benefits for children with ADHD and their families.

Who is the study for?

This trial is for children aged 8-12 with ADHD, as diagnosed by K-SADS. They must have ADHD symptoms rated in the clinical/borderline range by both parents and teachers. Children with seizure disorders, psychosis, bipolar disorder, severe dysregulation disorders, gross impairments or intellectual disability are excluded.

What is being tested?

The study tests combining Central Executive Training (CET), a computer program to improve working memory and reduce ADHD symptoms, with Behavioral Parent Training (BPT) which aims to enhance family dynamics and decrease oppositional-defiant behaviors in children.

What are the potential side effects?

As CET involves computerized tasks and BPT involves therapeutic strategies without medication, side effects are minimal but may include frustration or fatigue from cognitive exercises and potential stress during behavioral adjustments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

4Treatment groups

Experimental Treatment

Group I: Waitlist then CET+BPTExperimental Treatment2 Interventions

Families do not receive either intervention in Phase 1 and then receive both CET and BPT concurrently in Phase 2

Group II: CET-then-BPTExperimental Treatment2 Interventions

Families receive CET in Phase 1 followed by BPT in Phase 2

Group III: CET+BPT then 'waitlist' (follow-up)Experimental Treatment2 Interventions

Families receive CET and BPT concurrently in Phase 1, and then are followed in Phase 2 with not additional intervention

Group IV: BPT-then-CETExperimental Treatment2 Interventions

Families receive BPT in Phase 1 followed by CET in Phase 2

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Behavioral Parent Training (BPT)

2022

N/A

~40

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

Central Executive Training (CET) improves ADHD symptoms by enhancing working memory, which helps patients better manage tasks and maintain focus. Behavioral Parent Training (BPT) modifies parenting behaviors to create a structured and supportive environment, reducing oppositional-defiant disorder (ODD) symptoms and improving family functioning. These treatments are crucial as they address both cognitive deficits and environmental factors, offering a comprehensive approach to managing ADHD.

Bibliotherapy as an adjunct to stimulant medication in the treatment of attention-deficit hyperactivity disorder.Children with ADHD treated with long-term methylphenidate and multimodal psychosocial treatment: impact on parental practices.

Find a Location

Who is running the clinical trial?

Florida State UniversityLead Sponsor

213 Previous Clinical Trials

34,296 Total Patients Enrolled

3 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)

604 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)

Media Library

Behavioral Parent Training (BPT) (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05492422 — N/A

Attention Deficit Hyperactivity Disorder (ADHD) Research Study Groups: CET-then-BPT, BPT-then-CET, Waitlist then CET+BPT, CET+BPT then 'waitlist' (follow-up)

Attention Deficit Hyperactivity Disorder (ADHD) Clinical Trial 2023: Behavioral Parent Training (BPT) Highlights & Side Effects. Trial Name: NCT05492422 — N/A

Behavioral Parent Training (BPT) (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05492422 — N/A

Attention Deficit Hyperactivity Disorder (ADHD) Patient Testimony for trial: Trial Name: NCT05492422 — N/A

~110 spots leftby Jan 2027

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