CET + BPT for ADHD

Recruiting in Palo Alto (17 mi)

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Florida State University

Disqualifiers: Seizure disorder, Psychosis, Bipolar, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment CET + BPT for ADHD?

Research shows that Behavioral Parent Training (BPT) is effective in improving behaviors like inattention, hyperactivity, and impulsivity in children with ADHD, and it also reduces parental stress. BPT is recommended as a first-line treatment for young children with ADHD and as part of a combination approach for older children. ^{1 2 3 4 5}

Is Behavioral Parent Training (BPT) safe for humans?

Behavioral Parent Training (BPT) is generally considered safe for humans and has been shown to improve parenting practices and reduce stress in parents of children with ADHD. ^{1 2 3 4 6}

How is the CET + BPT treatment for ADHD different from other treatments?

The CET + BPT treatment for ADHD is unique because it combines Central Executive Training (CET), which focuses on improving cognitive functions like attention and working memory, with Behavioral Parent Training (BPT), which helps parents manage their child's behavior and reduce stress. This dual approach addresses both cognitive and behavioral aspects of ADHD, making it different from treatments that focus solely on medication or behavior management. ^{1 2 3 4 6}

Research Team

Eligibility Criteria

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.

Inclusion Criteria

I have been diagnosed with ADHD.

Parent AND teacher ratings in clinical/borderline range based on age and sex on ADHD Rating Scale (ADHD-5) or Behavior Assessment Scale for Children (BASC-3) Attention Problems/Hyperactivity subscales (i.e., 90th percentile or higher based on both informants)

My child is between 8-12 years old and has been diagnosed with ADHD.

Exclusion Criteria

I am not in need of immediate help for thoughts of harming myself.

Intellectual disability or Wechsler Intelligence Scale for Children (WISC-V) short-form standard score <70

Either I or my child do not speak English.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Central Executive Training (CET)

Participants receive Central Executive Training to improve ADHD symptoms and academic functioning

6-8 weeks

Behavioral Parent Training (BPT)

Participants receive Behavioral Parent Training to improve family functioning and child ODD symptoms

6-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Behavioral Parent Training (BPT) (Behavioural Intervention)
• Central Executive Training (CET) (Behavioural Intervention)

Trial Overview 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.

Participant Groups

Group I: Waitlist then CET+BPT Experimental Treatment 2 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-BPT Experimental Treatment 2 Interventions

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

Group III: CET+BPT then 'waitlist' (follow-up) Experimental Treatment 2 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-CET Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

Florida State University

Lead Sponsor

Trials

234

Recruited

41,100+

Jim Scholefield

Florida State University

Chief Executive Officer since 2023

Bachelor of Science in Management from Florida State University

Dr. Stanley Iyadurai

Florida State University

Chief Medical Officer since 2023

MD and PhD from University of Minnesota

Findings from Research

Behavioral Parent Training (BPT) is an effective first-line treatment for children with ADHD under six years old and a recommended combination treatment for older children, showing significant improvements in problem behaviors like inattention and hyperactivity.

The study demonstrated that BPT significantly improved parenting practices, as evidenced by changes in Parenting Scale scores, indicating that it can reduce negative parenting behaviors and enhance outcomes for children with ADHD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does a Behavioral Parent Training Program for Parents of ADHD Children Improve Outcomes? A Pilot Project. Morgan, TC., O'Keefe, LC.[2021]

Behavioral parent training (BPT) is an effective treatment for ADHD, improving both child behavior and parenting practices, as well as reducing parenting stress and enhancing classroom behavior.

Despite its effectiveness, research on BPT for ADHD is less comprehensive than for other disorders like oppositional defiant disorder (ODD) and conduct disorder (CD), highlighting the need for further studies to understand factors affecting treatment outcomes, especially given the high comorbidity between ADHD and these disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancements to the behavioral parent training paradigm for families of children with ADHD: review and future directions. Chronis, AM., Chacko, A., Fabiano, GA., et al.[2019]

Behavioral parent training (BPT) is an evidence-based intervention for treating early-onset disruptive behavior disorders, and this review highlights the foundational work of key figures in developing effective BPT programs.

The review aims to guide clinicians and agencies in selecting and adapting various BPT programs, such as COPE and Parent-Child Interaction Therapy, to better address the unique needs of children and families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Distilling Common History and Practice Elements to Inform Dissemination: Hanf-Model BPT Programs as an Example. Kaehler, LA., Jacobs, M., Jones, DJ.[2018]

In a study of parents attending behavioral parent training (BPT) for children with ADHD, 37.3% of parents exhibited ADHD symptoms that met clinical criteria, indicating a significant prevalence of ADHD among these parents.

Parents with higher ADHD symptoms were more likely to display off-task behaviors during BPT, which may hinder their ability to learn new parenting skills and could explain the challenges in achieving positive outcomes from the training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral Observations of Parents With ADHD During Parent Training. Babinski, DE., Waxmonsky, JG., Waschbusch, DA., et al.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Which Techniques Work in Behavioral Parent Training for Children with ADHD? A Randomized Controlled Microtrial. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Does a Behavioral Parent Training Program for Parents of ADHD Children Improve Outcomes? A Pilot Project. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Behavioral Parent Training for ADHD Reduces Situational Severity of Child Noncompliance and Related Parental Stress. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Enhancements to the behavioral parent training paradigm for families of children with ADHD: review and future directions. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Distilling Common History and Practice Elements to Inform Dissemination: Hanf-Model BPT Programs as an Example. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Behavioral Observations of Parents With ADHD During Parent Training. [2019]