Clinical trial NCT05492422: Central Executive Training and Parent Training for ADHD
Official title: Evaluating the Efficacy of Sequenced Central Executive and Behavioral Parent Training for Children with ADHD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ADHD
Lead sponsor: Florida State University
Sponsor class: OTHER
First posted: 2022-08-08
Enrollment: 200
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Rapport visuospatial/phonological working memory test
timeFrame: Administered during a 3 hour post-treatment testing session occurring within 2 weeks of last intervention session
measure: Alabama parenting scale
timeFrame: 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
measure: Parenting sense of competence scale
timeFrame: 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
measure: Parent stress index
timeFrame: 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:
measure: Behavior Assessment System for Children
timeFrame: 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
measure: ADHD Rating Scale
timeFrame: 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
measure: ODD symptoms (DSM-based checklist)
timeFrame: 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:
measure: Academic performance rating scale
timeFrame: Teacher questionnaire requiring approximately 15 minutes to complete, mailed to teacher within 2 weeks of last intervention session
measure: Parent relationship questionnaire
timeFrame: 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
measure: Dyadic parent-child interaction coding system (DPICS)
timeFrame: Structured parent-child interaction conducted during the post-treatment testing session within 2 weeks of final intervention session
Locations:
city: Tallahassee
country: United States
facility: Florida State University
state: Florida
Study officials:
References: