STAND Community Trial (STAND)
Primary Purpose
Attention Deficit Hyperactivity Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
STAND (Behavior Therapy + Motivational Interviewing)
Usual Care
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder
Eligibility Criteria
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
Sites / Locations
- Florida International University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
STAND
Usual Care
Arm Description
Receives STAND intervention delivered in community mental health setting.
Receives usual care from community therapists.
Outcomes
Primary Outcome Measures
School Grades
GPA
ADHD Symptoms
Conners, ADHD Checklist
Behavior Problems in School
Official Disciplinary Records from School District
Academic Problems
Adolescent Academic Problems Checklist
Parent Teen Conflict
Conflict Behavior Questionnaire, Video Interaction Tasks
Secondary Outcome Measures
Satisfaction with Treatment
Rating Scale of Patient Satisfaction with all aspects of Treatment
Quality of Therapeutic Relationship between the therapist and the patient
Patient report on therapeutic alliance
Organization Skills
Direct observation of recording homework and book bag organization
Executive Functioning
BRIEF rating scale, DKEFS, AWMA
Motivation
Motivation (readiness) ruler, hungry donkey task, choice delay task,
Parent academic Involvement
Parent report of academic management, number of hours spent helping, video interaction task
parent-teen communication
video tasks
parent readiness to change
Motivation (readiness) ruler, parent change talk
Full Information
NCT ID
NCT02694939
First Posted
July 24, 2015
Last Updated
February 2, 2021
Sponsor
Florida International University
1. Study Identification
Unique Protocol Identification Number
NCT02694939
Brief Title
STAND Community Trial
Acronym
STAND
Official Title
Effectiveness of MI Enhanced Behavior Therapy for Adolescents With ADHD
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
May 2015 (Actual)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
October 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Florida International University
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
278 (Actual)
8. Arms, Groups, and Interventions
Arm Title
STAND
Arm Type
Experimental
Arm Description
Receives STAND intervention delivered in community mental health setting.
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Receives usual care from community therapists.
Intervention Type
Behavioral
Intervention Name(s)
STAND (Behavior Therapy + Motivational Interviewing)
Intervention Description
Parent-teen collaborative skills based behavior therapy targeting Executive functioning and Delay Aversion in Teens
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Intervention Description
Community Therapists free to deliver any therapy they feel is indicated.
Primary Outcome Measure Information:
Title
School Grades
Description
GPA
Time Frame
7 months
Title
ADHD Symptoms
Description
Conners, ADHD Checklist
Time Frame
7 months
Title
Behavior Problems in School
Description
Official Disciplinary Records from School District
Time Frame
7 months
Title
Academic Problems
Description
Adolescent Academic Problems Checklist
Time Frame
7 months
Title
Parent Teen Conflict
Description
Conflict Behavior Questionnaire, Video Interaction Tasks
Time Frame
7 months
Secondary Outcome Measure Information:
Title
Satisfaction with Treatment
Description
Rating Scale of Patient Satisfaction with all aspects of Treatment
Time Frame
7 months
Title
Quality of Therapeutic Relationship between the therapist and the patient
Description
Patient report on therapeutic alliance
Time Frame
7 months
Title
Organization Skills
Description
Direct observation of recording homework and book bag organization
Time Frame
7 months
Title
Executive Functioning
Description
BRIEF rating scale, DKEFS, AWMA
Time Frame
7 months
Title
Motivation
Description
Motivation (readiness) ruler, hungry donkey task, choice delay task,
Time Frame
7 months
Title
Parent academic Involvement
Description
Parent report of academic management, number of hours spent helping, video interaction task
Time Frame
7 months
Title
parent-teen communication
Description
video tasks
Time Frame
7 months
Title
parent readiness to change
Description
Motivation (readiness) ruler, parent change talk
Time Frame
7 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Florida International University
City
Miami
State/Province
Florida
ZIP/Postal Code
33199
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
33988847
Citation
Sibley MH, Ortiz M, Rios-Davis A, Zulauf-McCurdy CA, Graziano PA, Bickman L. Stakeholder-Generated Implementation Strategies to Promote Evidence-Based ADHD Treatment in Community Mental Health. Adm Policy Ment Health. 2022 Jan;49(1):44-58. doi: 10.1007/s10488-021-01143-5. Epub 2021 May 14.
Results Reference
derived
PubMed Identifier
32861773
Citation
Sibley MH, Graziano PA, Coxe S, Bickman L, Martin P. Effectiveness of Motivational Interviewing-Enhanced Behavior Therapy for Adolescents With Attention-Deficit/Hyperactivity Disorder: A Randomized Community-Based Trial. J Am Acad Child Adolesc Psychiatry. 2021 Jun;60(6):745-756. doi: 10.1016/j.jaac.2020.07.907. Epub 2020 Aug 28.
Results Reference
derived
PubMed Identifier
32103410
Citation
Sibley MH, Graziano PA, Bickman L, Coxe SJ, Martin P, Rodriguez LM, Fallah N, Ortiz M. Implementing Parent-Teen Motivational Interviewing + Behavior Therapy for ADHD in Community Mental Health. Prev Sci. 2021 Aug;22(6):701-711. doi: 10.1007/s11121-020-01105-7.
Results Reference
derived
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STAND Community Trial
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