Evaluating the Efficacy of Central Executive Training (CET) For Young Children With ADHD
ConditionADHD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-8
SponsorFlorida State University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
(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.
Trial design
Design model
Crossover
Treatments tested in this trial
Central executive training
BehavioralComputerized, adaptive central executive working memory training protocol
Behavioral parent training
BehavioralBehavioral parent training
Treatment groups
120 Participants
are divided into 4 treatment groupsGroup A: Central executive trainingExperimental treatment 1 intervention
Group B: Behavioral parent trainingActive comparator 1 intervention
Group C: Central executive training + concurrent behavioral parent trainingOther 2 interventions
Group D: Treatment as usual/waitlistNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
ADHD Rating Scale (ADHD-RS)
Time frame
Change from baseline to immediate post-treatment and maintenance of gains up to 3 months after treatment completionSecondary outcomes
1
Secondary outcomes (T-scores)
Informant reports of social skills, emotion regulation, parent-child relationships, and impairments
Time frame
Change from baseline to immediate post-treatment and maintenance of gains up to 3 months after treatment completion2
Feasibility/acceptability
Client satisfaction, system usability, expectancies
Time frame
Change from baseline to immediate post-treatment and maintenance of gains up to 3 months after treatment completionOther outcomes
1
Working memory test battery
Time frame
Change from baseline to immediate post-treatment and maintenance of gains up to 3 months after treatment completion2
Actigraphy (Proportional Integrating Measure)
Time frame
Change from baseline to immediate post-treatment and maintenance of gains up to 3 months after treatment completion3
Academic performance rating scale
Time frame
Change from baseline to immediate post-treatment and maintenance of gains up to 3 months after treatment completionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Florida State University
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov