STAND Community Trial

• Sponsor: Florida International University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02694939
• Collaborator: (none)
• Enrollment: 278
• Location: 1
• Arms: 2
• Actual Duration (Months): 66
• Patients Per Site Per Month: 4.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Attention Deficit Hyperactivity Disorder	Behavioral: STAND (Behavior Therapy + Motivational Interviewing); Behavioral: Usual Care	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 278 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effectiveness of MI Enhanced Behavior Therapy for Adolescents With ADHD
• Actual Study Start Date: May 1, 2015
• Actual Primary Completion Date: Dec 1, 2018
• Actual Study Completion Date: Oct 31, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. School Grades [7 months]

   GPA

2. ADHD Symptoms [7 months]

   Conners, ADHD Checklist

3. Behavior Problems in School [7 months]

   Official Disciplinary Records from School District

4. Academic Problems [7 months]

   Adolescent Academic Problems Checklist

5. Parent Teen Conflict [7 months]

   Conflict Behavior Questionnaire, Video Interaction Tasks

Secondary Outcome Measures

1. Satisfaction with Treatment [7 months]

   Rating Scale of Patient Satisfaction with all aspects of Treatment

2. Quality of Therapeutic Relationship between the therapist and the patient [7 months]

   Patient report on therapeutic alliance

3. Organization Skills [7 months]

   Direct observation of recording homework and book bag organization

4. Executive Functioning [7 months]

   BRIEF rating scale, DKEFS, AWMA

5. Motivation [7 months]

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

6. Parent academic Involvement [7 months]

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

7. parent-teen communication [7 months]

   video tasks

8. parent readiness to change [7 months]

   Motivation (readiness) ruler, parent change talk

Eligibility Criteria

Criteria

• Ages Eligible for Study: 11 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Florida International University	Miami	Florida	United States	33199

Sponsors and Collaborators

• Florida International University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Florida International University
• ClinicalTrials.gov Identifier: NCT02694939
• Other Study ID Numbers: R01MH106587
• First Posted: Mar 1, 2016
• Last Update Posted: Feb 3, 2021
• Last Verified: Feb 1, 2021

• Additional relevant MeSH terms: Attention Deficit Disorder with Hyperactivity

Study Results

No Results Posted as of Feb 3, 2021