STAND Community Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

278 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2020-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Attention Deficit Hyperactivity Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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STAND

Receives STAND intervention delivered in community mental health setting.

Group Type EXPERIMENTAL

STAND (Behavior Therapy + Motivational Interviewing)

Intervention Type BEHAVIORAL

Parent-teen collaborative skills based behavior therapy targeting Executive functioning and Delay Aversion in Teens

Usual Care

Receives usual care from community therapists.

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type BEHAVIORAL

Community Therapists free to deliver any therapy they feel is indicated.

Interventions

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STAND (Behavior Therapy + Motivational Interviewing)

Parent-teen collaborative skills based behavior therapy targeting Executive functioning and Delay Aversion in Teens

Intervention Type BEHAVIORAL

Usual Care

Community Therapists free to deliver any therapy they feel is indicated.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

11 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No