Clinical trial NCT02694939: STAND Community Trial
Official title: Effectiveness of MI Enhanced Behavior Therapy for Adolescents With ADHD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Lead sponsor: Florida International University
Sponsor class: OTHER
First posted: 2016-03-01
Enrollment: 278
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The proposed study evaluates the effectiveness of a family-based psychosocial treatment program for teens with ADHD (Supporting Teens' Academic Needs Daily; STAND) developed to be delivered in community settings. STAND is BT enhanced by Motivational Interviewing (MI) that was developed (R34 MH092466) for teens with ADHD through a stakeholder informed process. STAND consists of ten 50-minute sessions delivered by therapists with community-typical levels of training and supervision. Across randomized controlled pilot (N=28; N=36) and efficacy trials (N=128), STAND demonstrates medium to large effects on ADHD and ODD symptoms and indices of academic and family impairment. In the proposed study, 300 adolescents with ADHD who present for treatment at one of four community mental health agencies in Miami-Dade County, FL will be randomly assigned to STAND or agency usual care (UC). Participating agency therapists also will be randomly assigned to deliver STAND or UC. STAND therapists will receive a comprehensive treatment manual, three-day training, and weekly supervision from a project psychologist. Participants will be screened by research staff in the community setting and enrolled on a rolling basis over 30 months. Participants will be assessed at baseline, post-treatment, and three-month follow-up. In line with RDoC, multi-method measures will be obtained for treatment outcome (family and academic impairment), treatment mediators (executive functioning, parent academic involvement, parent-teen communication, parent/adolescent motivation, ADHD symptoms), and moderators of effectiveness (patient, practitioner, service delivery, and organization characteristics). Additional consumer perspective (satisfaction, therapeutic alliance) and agency fit (therapist competence, treatment fidelity, need for additional treatment, attendance, therapist attitude toward treatment, cost effectiveness) measures will also be obtained to evaluate effectiveness. We will recruit an ethnically diverse sample (65% Hispanic, 19% African-American, 16% Non-Hispanic White) that is historically underrepresented in research, but ideal for evaluating therapy effectiveness.


Eligibility criteria: Inclusion Criteria:

* ADHD diagnosis
* IQ of at least 70
* Enrollment in sixth through twelfth grade

Exclusion Criteria:

* history of autism spectrum disorder
* not attending a Miami-Dade County Public School
* a primary presenting problem other than ADHD, requiring immediate treatment of a different domain

Primary outcomes:
measure: School Grades
timeFrame: 7 months
measure: ADHD Symptoms
timeFrame: 7 months
measure: Behavior Problems in School
timeFrame: 7 months
measure: Academic Problems
timeFrame: 7 months
measure: Parent Teen Conflict
timeFrame: 7 months
Secondary outcomes:
measure: Satisfaction with Treatment
timeFrame: 7 months
measure: Quality of Therapeutic Relationship between the therapist and the patient
timeFrame: 7 months
measure: Organization Skills
timeFrame: 7 months
measure: Executive Functioning
timeFrame: 7 months
measure: Motivation
timeFrame: 7 months
measure: Parent academic Involvement
timeFrame: 7 months
measure: parent-teen communication
timeFrame: 7 months
measure: parent readiness to change
timeFrame: 7 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: Florida International University
state: Florida
Study officials:
References:
citation: Sibley MH, Ortiz M, Rios-Davis A, Zulauf-McCurdy CA, Graziano PA, Bickman L. Stakeholder-Generated Implementation Strategies to Promote Evidence-Based ADHD Treatment in Community Mental Health. Adm Policy Ment Health. 2022 Jan;49(1):44-58. doi: 10.1007/s10488-021-01143-5. Epub 2021 May 14.
citation: Sibley MH, Graziano PA, Coxe S, Bickman L, Martin P. Effectiveness of Motivational Interviewing-Enhanced Behavior Therapy for Adolescents With Attention-Deficit/Hyperactivity Disorder: A Randomized Community-Based Trial. J Am Acad Child Adolesc Psychiatry. 2021 Jun;60(6):745-756. doi: 10.1016/j.jaac.2020.07.907. Epub 2020 Aug 28.
citation: Sibley MH, Graziano PA, Bickman L, Coxe SJ, Martin P, Rodriguez LM, Fallah N, Ortiz M. Implementing Parent-Teen Motivational Interviewing + Behavior Therapy for ADHD in Community Mental Health. Prev Sci. 2021 Aug;22(6):701-711. doi: 10.1007/s11121-020-01105-7.