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STAND Community Trial

Florida International University (FIU) logo

Florida International University (FIU)

Status

Completed

Conditions

Attention Deficit Hyperactivity Disorder

Treatments

Behavioral: Usual Care
Behavioral: STAND (Behavior Therapy + Motivational Interviewing)

Study type

Interventional

Funder types

Other

Identifiers

NCT02694939
R01MH106587

Details and patient eligibility

About

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.

Enrollment

278 patients

Sex

All

Ages

11 to 17 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Single Blind

278 participants in 2 patient groups

STAND
Experimental group
Description:
Receives STAND intervention delivered in community mental health setting.
Treatment:
Behavioral: STAND (Behavior Therapy + Motivational Interviewing)
Usual Care
Active Comparator group
Description:
Receives usual care from community therapists.
Treatment:
Behavioral: Usual Care

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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