Central Executive Training and Parent Training for ADHD

NCT05492422 | Recruiting DMC FDA Device

• 1 other identifier: 1R01MH125893
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• Rapport visuospatial/phonological working memory test

  Administered during a 3 hour post-treatment testing session occurring within 2 weeks of last intervention session

• Alabama parenting scale

  Parent questionnaire requiring approximately 15 minutes to complete, administered to parent while child is completing the 3 hour post-treatment testing session occurring within 2 weeks of last intervention session

• Parenting sense of competence scale

  Parent questionnaire requiring approximately 15 minutes to complete, administered to parent while child is completing the 3 hour post-treatment testing session occurring within 2 weeks of last intervention session

• Parent stress index

  Parent questionnaire requiring approximately 15 minutes to complete, administered to parent while child is completing the 3 hour post-treatment testing session occurring within 2 weeks of last intervention session

Secondary Outcomes (3)

• Behavior Assessment System for Children

  Parent and teacher questionnaire requiring approximately 15 minutes to complete, administered to parent and mailed to teacher while child is completing the 3 hour post-treatment testing session occurring within 2 weeks of last intervention session

• ADHD Rating Scale

  Parent and teacher questionnaire requiring approximately 15 minutes to complete, administered to parent and mailed to teacher while child is completing the 3 hour post-treatment testing session occurring within 2 weeks of last intervention session

• ODD symptoms (DSM-based checklist)

  Parent and teacher questionnaire requiring approximately 15 minutes to complete, administered to parent and mailed to teacher while child is completing the 3 hour post-treatment testing session occurring within 2 weeks of last intervention session

Other Outcomes (3)

• Academic performance rating scale

  Teacher questionnaire requiring approximately 15 minutes to complete, mailed to teacher within 2 weeks of last intervention session

• Parent relationship questionnaire

  Parent questionnaire requiring approximately 15 minutes to complete, administered to parent while child is completing the 3 hour post-treatment testing session occurring within 2 weeks of last intervention session

• Dyadic parent-child interaction coding system (DPICS)

  Structured parent-child interaction conducted during the post-treatment testing session within 2 weeks of final intervention session

Study Arms (4)

CET-then-BPT

EXPERIMENTAL

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

Device: Central Executive Training (CET); Behavioral: Behavioral Parent Training (BPT)

BPT-then-CET

EXPERIMENTAL

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

Device: Central Executive Training (CET); Behavioral: Behavioral Parent Training (BPT)

Waitlist then CET+BPT

EXPERIMENTAL

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

Device: Central Executive Training (CET); Behavioral: Behavioral Parent Training (BPT)

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

EXPERIMENTAL

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

Device: Central Executive Training (CET); Behavioral: Behavioral Parent Training (BPT)

Interventions

Behavioral Parent Training (BPT) BEHAVIORAL

Behavioral Parent Training (BPT)

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

Central Executive Training (CET) DEVICE

Central Executive Training (CET)

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

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• gross neurological, sensory, or motor impairment;
• 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);
• intellectual disability or Wechsler Intelligence Scale for Children (WISC-V) short-form standard score \<70;
• conditions requiring acute intervention, e.g., active suicidality; and
• non-English speaking child or parent.

Sponsors & Collaborators

• Florida State University: lead

Study Sites (1)

Florida State University

Tallahassee, Florida, 32306, United States

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Children's Learning Clinic

CONTACT

8506457423; clc@psy.fsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 1, 2022
• First Posted: August 8, 2022
• Study Start: October 3, 2022
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: April 2, 2026

Record last verified: 2026-03

Locations

US (1)