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Completed

NCT Number: NCT02694939

STAND Community Trial

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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Key information

Age range

11 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Florida International University

Miami, Florida, 33199, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

STAND (Behavior Therapy + Motivational Interviewing)

Behavioral

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

Usual Care

Behavioral

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

Primary outcomes

  1. School Grades

    Time frame: 7 months

    GPA

  2. ADHD Symptoms

    Time frame: 7 months

    Conners, ADHD Checklist

  3. Behavior Problems in School

    Time frame: 7 months

    Official Disciplinary Records from School District

  4. Academic Problems

    Time frame: 7 months

    Adolescent Academic Problems Checklist

  5. Parent Teen Conflict

    Time frame: 7 months

    Conflict Behavior Questionnaire, Video Interaction Tasks

Secondary outcomes

  1. Satisfaction with Treatment

    Time frame: 7 months

    Rating Scale of Patient Satisfaction with all aspects of Treatment

  2. Quality of Therapeutic Relationship between the therapist and the patient

    Time frame: 7 months

    Patient report on therapeutic alliance

  3. Organization Skills

    Time frame: 7 months

    Direct observation of recording homework and book bag organization

  4. Executive Functioning

    Time frame: 7 months

    BRIEF rating scale, DKEFS, AWMA

  5. Motivation

    Time frame: 7 months

    Motivation (readiness) ruler, hungry donkey task, choice delay task,

  6. Parent academic Involvement

    Time frame: 7 months

    Parent report of academic management, number of hours spent helping, video interaction task

  7. parent-teen communication

    Time frame: 7 months

    video tasks

  8. parent readiness to change

    Time frame: 7 months

    Motivation (readiness) ruler, parent change talk

Sponsors and collaborators

Lead sponsor

Florida International University

Other

Registry information

Official study title

Effectiveness of MI Enhanced Behavior Therapy for Adolescents With ADHD

Acronym: STAND

Important dates

Study start
2015
Primary completion
2018
Study completion
2020
First posted
Mar 1, 2016
Registry last updated
Feb 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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