STAND Community Trial (STAND)

February 2, 2021 updated by: Florida International University

Effectiveness of MI Enhanced Behavior Therapy for Adolescents With ADHD

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

278

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33199
        • Florida International University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: STAND
Receives STAND intervention delivered in community mental health setting.
Behavioral: STAND (Behavior Therapy + Motivational Interviewing)
Parent-teen collaborative skills based behavior therapy targeting Executive functioning and Delay Aversion in Teens
Active Comparator: Usual Care
Receives usual care from community therapists.
Behavioral: Usual Care
Community Therapists free to deliver any therapy they feel is indicated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
School Grades
Time Frame: 7 months
GPA
7 months
ADHD Symptoms
Time Frame: 7 months
Conners, ADHD Checklist
7 months
Behavior Problems in School
Time Frame: 7 months
Official Disciplinary Records from School District
7 months
Academic Problems
Time Frame: 7 months
Adolescent Academic Problems Checklist
7 months
Parent Teen Conflict
Time Frame: 7 months
Conflict Behavior Questionnaire, Video Interaction Tasks
7 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction with Treatment
Time Frame: 7 months
Rating Scale of Patient Satisfaction with all aspects of Treatment
7 months
Quality of Therapeutic Relationship between the therapist and the patient
Time Frame: 7 months
Patient report on therapeutic alliance
7 months
Organization Skills
Time Frame: 7 months
Direct observation of recording homework and book bag organization
7 months
Executive Functioning
Time Frame: 7 months
BRIEF rating scale, DKEFS, AWMA
7 months
Motivation
Time Frame: 7 months
Motivation (readiness) ruler, hungry donkey task, choice delay task,
7 months
Parent academic Involvement
Time Frame: 7 months
Parent report of academic management, number of hours spent helping, video interaction task
7 months
parent-teen communication
Time Frame: 7 months
video tasks
7 months
parent readiness to change
Time Frame: 7 months
Motivation (readiness) ruler, parent change talk
7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Florida International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2015

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

October 31, 2020

Study Registration Dates

First Submitted

July 24, 2015

First Submitted That Met QC Criteria

February 24, 2016

First Posted (Estimate)

March 1, 2016

Study Record Updates

Last Update Posted (Actual)

February 3, 2021

Last Update Submitted That Met QC Criteria

February 2, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01MH106587 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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