Central Executive Training and Parent Training for ADHD

NCT ID: NCT05492422

Last Updated: 2025-03-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-03
• Study Completion Date: 2027-07-31

Brief Summary

The goal of the current project is to combine two evidence- based treatments for school-aged children with ADHD: Central Executive Training (CET) and Behavioral Parent Training (BPT). CET is a computerized training intervention that improves ADHD symptoms and academic functioning by improving children's working memory abilities. BPT is a therapeutic intervention that improves family functioning and child oppositional-defiant (ODD) symptoms by changing parenting behaviors. Their combined use is expected to provide complementary and additive benefits, particularly if CET is delivered before BPT.

Conditions

ADHD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

CET-then-BPT

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

Group Type: EXPERIMENTAL

Central Executive Training (CET)

Intervention Type: DEVICE

Central Executive Training (CET)

Behavioral Parent Training (BPT)

Intervention Type: BEHAVIORAL

Behavioral Parent Training (BPT)

BPT-then-CET

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

Group Type: EXPERIMENTAL

Central Executive Training (CET)

Intervention Type: DEVICE

Central Executive Training (CET)

Behavioral Parent Training (BPT)

Intervention Type: BEHAVIORAL

Behavioral Parent Training (BPT)

Waitlist then CET+BPT

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

Group Type: EXPERIMENTAL

Central Executive Training (CET)

Intervention Type: DEVICE

Central Executive Training (CET)

Behavioral Parent Training (BPT)

Intervention Type: BEHAVIORAL

Behavioral Parent Training (BPT)

CET+BPT then 'waitlist' (follow-up)

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

Group Type: EXPERIMENTAL

Central Executive Training (CET)

Intervention Type: DEVICE

Central Executive Training (CET)

Behavioral Parent Training (BPT)

Intervention Type: BEHAVIORAL

Behavioral Parent Training (BPT)

Interventions

Central Executive Training (CET)

Central Executive Training (CET)

Intervention Type: DEVICE

Behavioral Parent Training (BPT)

Behavioral Parent Training (BPT)

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Children ages 8-12 with principal ADHD diagnoses (via K-SADS); and

2. 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).

All DSM-5 ADHD presentations will be eligible.

Exclusion:

1. gross neurological, sensory, or motor impairment;

2. 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);

3. intellectual disability or Wechsler Intelligence Scale for Children (WISC-V) short-form standard score <70;

4. conditions requiring acute intervention, e.g., active suicidality; and

5. non-English speaking child or parent.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Florida State University

OTHER

Sponsor Role: lead

Responsible Party

Michael J. Kofler

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Florida State University

Tallahassee, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Children's Learning Clinic

Role: CONTACT

clc@psy.fsu.edu

8506457423

Facility Contacts

Children's Learning Clinic

Role: primary

clc@psy.fsu.edu

850-645-7423

Other Identifiers

1R01MH125893

Identifier Type: NIH

Identifier Source: org_study_id

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