CET + BPT for ADHD

Overseen By Children's Learning Clinic

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Florida State University

Disqualifiers: Seizure disorder, Psychosis, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how combining two treatments can help children with ADHD improve their daily lives. The first treatment, Central Executive Training (CET), is a computer-based program designed to boost children's working memory, easing ADHD symptoms and enhancing school performance. The second treatment, Behavioral Parent Training (BPT), involves parents to improve family dynamics and reduce behaviors like defiance. Children aged 8-12 with ADHD, rated by both parents and teachers as having significant attention or hyperactivity issues, might be a good fit for this trial. As an unphased trial, this study offers families a unique opportunity to contribute to innovative ADHD treatment strategies.

Will I have to stop taking my current medications?

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

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that Central Executive Training (CET) is generally well-tolerated by children with ADHD. Research indicates that CET can improve their organizational skills and behavior without significant side effects. Similarly, Behavioral Parent Training (BPT) is safe for children with ADHD. Previous studies highlight its effectiveness in helping parents develop better strategies and improve their child's behavior without major safety concerns. Both treatments have been used in various settings and are considered safe options for managing ADHD symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for ADHD because they blend cognitive and behavioral strategies in a unique way. Central Executive Training (CET) is designed to enhance the brain's ability to focus and manage tasks, targeting the executive function deficits often seen in ADHD. This differs from conventional treatments like medication or basic behavioral therapy, which might not directly address these cognitive skills. Behavioral Parent Training (BPT) empowers parents with strategies to support their kids, adding an essential family dynamic to the treatment. Unlike standard ADHD treatments, these innovative approaches aim to create lasting changes in both cognitive functions and family interactions.

What evidence suggests that this trial's treatments could be effective for ADHD?

Research has shown that Central Executive Training (CET), which participants in this trial may receive, improves ADHD symptoms in children by boosting their working memory. Studies indicate that CET significantly enhances organizational skills in school, with strong and lasting effects. In contrast, Behavioral Parent Training (BPT), another treatment option in this trial, reduces ADHD and oppositional-defiant symptoms by teaching parents more effective strategies. BPT has demonstrated long-term benefits for both children's behavior and family life. This trial will explore different sequences and combinations of CET and BPT, which are expected to provide complementary benefits, potentially improving both school performance and family interactions for children with ADHD. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

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

History of seizure disorder, psychosis, bipolar, or severe dysregulation disorders that may interfere with participation (e.g., disruptive mood dysregulation, intermittent explosive, reactive attachment, substance use)

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

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

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.

How Is the Trial Designed?

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

Behavioral Parent Training (BPT) is already approved in United States for the following indications:

Approved in United States as Behavioral Parent Training for:

• Attention-deficit/hyperactivity disorder (ADHD)
• Oppositional defiant disorder (ODD)

Who Is Running the Clinical Trial?

Florida State University

Lead Sponsor

Trials

234

Recruited

41,100+

Published Research Related to This Trial

Behavioral parent training (BPT) significantly reduced the frequency and severity of problematic behaviors in children with ADHD, particularly in areas like chores, homework, and peer interactions, based on data from 304 parents.

Parents reported a notable decrease in stress related to parenting their child with ADHD after participating in BPT, indicating that this intervention not only helps children but also supports parental well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral Parent Training for ADHD Reduces Situational Severity of Child Noncompliance and Related Parental Stress. Ciesielski, HA., Loren, REA., Tamm, L.[2021]

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]

A study involving 92 parents of children with ADHD showed that brief training in either antecedent-based (AC) or consequent-based (CC) techniques significantly improved daily problem behaviors compared to a waitlist group.

Antecedent-based techniques were particularly effective in reducing inattention symptoms immediately after training and at a two-week follow-up, highlighting their importance in managing ADHD behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Which Techniques Work in Behavioral Parent Training for Children with ADHD? A Randomized Controlled Microtrial. Hornstra, R., van der Oord, S., Staff, AI., et al.[2022]

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]

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]

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]

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