Central Executive Training and Parent Training for ADHD

ADHD Clinical Trial

Official title:

Evaluating the Efficacy of Sequenced Central Executive and Behavioral Parent Training for Children With ADHD

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05492422
• Other study ID #: 1R01MH125893
• Status: Recruiting
• Phase: N/A
• Start date: October 3, 2022
• Est. completion date: July 31, 2027

Study information

• Verified date: June 2023
• Source: Florida State University
• Contact: Children's Learning Clinic
• Phone: 8506457423
• Email: clc[@]psy.fsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 31, 2027
• Est. primary completion date: January 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

Inclusion:

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.

Related Conditions & MeSH terms

• ADHD

Intervention

Device:
• Central Executive Training (CET)
Central Executive Training (CET)

Behavioral:
• Behavioral Parent Training (BPT)
Behavioral Parent Training (BPT)

Locations

Country	Name	City	State
United States	Florida State University	Tallahassee	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Florida State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Academic performance rating scale		Teacher questionnaire requiring approximately 15 minutes to complete, mailed to teacher within 2 weeks of last intervention session
Other	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
Other	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
Primary	Rapport visuospatial/phonological working memory test		Administered during a 3 hour post-treatment testing session occurring within 2 weeks of last intervention session
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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