Central Executive Training and Parent Training for ADHD

Florida State University

Status: Enrolling

Conditions: ADHD

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05492422

1R01MH125893

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 8 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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200 participants in 4 patient groups

CET-then-BPT

Experimental group

Description:

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

Treatment:

Device: Central Executive Training (CET)

Behavioral: Behavioral Parent Training (BPT)

BPT-then-CET

Experimental group

Description:

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

Treatment:

Device: Central Executive Training (CET)

Behavioral: Behavioral Parent Training (BPT)

Waitlist then CET+BPT

Experimental group

Description:

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

Treatment:

Device: Central Executive Training (CET)

Behavioral: Behavioral Parent Training (BPT)

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

Experimental group

Description:

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

Treatment:

Device: Central Executive Training (CET)

Behavioral: Behavioral Parent Training (BPT)