NCT07784348

Brief Summary

Initial non-randomized trial of behavioral parent training (BPT) compared to central executive training (CET), followed by a randomized controlled trial of CET+BPT for young children with ADHD.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
52mo left

Started May 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress35%
May 2024Dec 2030

Study Start

First participant enrolled

May 1, 2024

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

August 5, 2026

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 25, 2026

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

August 25, 2026

Status Verified

August 1, 2026

Enrollment Period

6.6 years

First QC Date

August 5, 2026

Last Update Submit

August 20, 2026

Conditions

ADHD

Keywords

ADHDCentral Executive TrainingBehavioral Parent Training

Outcome Measures

Primary Outcomes (1)

  • ADHD Rating Scale (ADHD-RS)

    Change from baseline to immediate post-treatment and maintenance of gains up to 3 months after treatment completion

Secondary Outcomes (2)

  • Secondary outcomes (T-scores)

    Change from baseline to immediate post-treatment and maintenance of gains up to 3 months after treatment completion

  • Feasibility/acceptability

    Change from baseline to immediate post-treatment and maintenance of gains up to 3 months after treatment completion

Other Outcomes (3)

  • Working memory test battery

    Change from baseline to immediate post-treatment and maintenance of gains up to 3 months after treatment completion

  • Actigraphy (Proportional Integrating Measure)

    Change from baseline to immediate post-treatment and maintenance of gains up to 3 months after treatment completion

  • Academic performance rating scale

    Change from baseline to immediate post-treatment and maintenance of gains up to 3 months after treatment completion

Study Arms (4)

Central executive training

EXPERIMENTAL
Behavioral: Central executive training

Behavioral parent training

ACTIVE COMPARATOR
Behavioral: Behavioral parent training

Central executive training + concurrent behavioral parent training

OTHER
Behavioral: Central executive trainingBehavioral: Behavioral parent training

Treatment as usual/waitlist

NO INTERVENTION

Interventions

Central executive trainingBEHAVIORAL

Computerized, adaptive central executive working memory training protocol

Central executive trainingCentral executive training + concurrent behavioral parent training
Behavioral parent trainingBEHAVIORAL

Behavioral parent training

Behavioral parent trainingCentral executive training + concurrent behavioral parent training

Eligibility Criteria

Age4 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • principal ADHD diagnoses (via K-SADS); (b) parent BASC-3 ADHD Problems or ADHD-RS ADHD-Combined scale in clinical/borderline range (\>90th percentile) based on age and sex; (c) teacher BASC-3 ADHD Problems or ADHD-RS ADHD-Combined scale in clinical/borderline range based on age and sex

You may not qualify if:

  • (a) gross neurological, sensory, or motor impairment; (b) history of seizure disorder, psychosis, bipolar, or severe dysregulation disorders that may interfere with study participation (e.g., disruptive mood dysregulation, conduct, intermittent explosive, reactive attachment); (c) intellectual disability or WPPSI/WISC short-form FSIQ\<70; (d) conditions requiring acute intervention, e.g., active suicidality; and (e) non-English speaking child or parent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Learning Clinic at 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 DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Michael Kofler, PhD

    Florida State University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Children's Learning Clinic

CONTACT

850-645-7423clc@psy.fsu.edu

Study Design

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

Study Record Dates

First Submitted

August 5, 2026

First Posted

August 25, 2026

Study Start

May 1, 2024

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Last Updated

August 25, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

Anonymized individual participant data that underlie results in a publication will be shared upon reasonable request, subject to approval by the study's Data and Safety Monitoring Board (DSMB) and execution of a Data Use Agreement (DUA).

Shared Documents
ANALYTIC CODE
Time Frame
During peer review of study manuscript or after publication, after obtaining approval by the study's Data and Safety Monitoring Board (DSMB) and execution of a Data Use Agreement (DUA).
Access Criteria
Approval by the study's Data and Safety Monitoring Board (DSMB) and execution of a Data Use Agreement (DUA).

Locations

US(1)