Evaluating the Efficacy of Sequenced Central Executive and Behavioral Parent Training for Children With ADHD
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Florida State University
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Parenting sense of competence scale
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Triple (Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 8 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
CET-then-BPT
Families receive CET in Phase 1 followed by BPT in Phase 2
Intervention: Central Executive Training (CET) (Device)
CET-then-BPT
Families receive CET in Phase 1 followed by BPT in Phase 2
Intervention: Behavioral Parent Training (BPT) (Behavioral)
BPT-then-CET
Families receive BPT in Phase 1 followed by CET in Phase 2
Intervention: Central Executive Training (CET) (Device)
BPT-then-CET
Families receive BPT in Phase 1 followed by CET in Phase 2
Intervention: Behavioral Parent Training (BPT) (Behavioral)
Waitlist then CET+BPT
Families do not receive either intervention in Phase 1 and then receive both CET and BPT concurrently in Phase 2
Intervention: Central Executive Training (CET) (Device)
Waitlist then CET+BPT
Families do not receive either intervention in Phase 1 and then receive both CET and BPT concurrently in Phase 2
Intervention: Behavioral Parent Training (BPT) (Behavioral)
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
Intervention: Central Executive Training (CET) (Device)
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
Intervention: Behavioral Parent Training (BPT) (Behavioral)
Outcomes
Primary Outcomes
Parenting sense of competence scale
Time Frame: 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
Time Frame: 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
Alabama parenting scale
Time Frame: 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
Rapport visuospatial/phonological working memory test
Time Frame: Administered during a 3 hour post-treatment testing session occurring within 2 weeks of last intervention session
Secondary Outcomes
- 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)
- 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)
Investigators
Michael J. Kofler
Associate Professor
Florida State University