Attention Deficit Hyperactivity DisorderSTANDNCT02694939
STAND Community Trial
A study testing STAND (Behavior Therapy + Motivational Interviewing) in people with Attention Deficit Hyperactivity Disorder, run by Florida International University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 17 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- STAND (Behavior Therapy + Motivational Interviewing)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 278 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to 31 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ADHD diagnosis
- IQ of at least 70
- Enrollment in sixth through twelfth grade
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida International University
Miami, Florida, 33199
About this study
Official title: 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.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- STAND (Behavior Therapy + Motivational Interviewing), Usual Care
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STAND (Behavior Therapy + Motivational Interviewing)Behavioural
Parent-teen collaborative skills based behavior therapy targeting Executive functioning and Delay Aversion in Teens
Usual CareBehavioural
Community Therapists free to deliver any therapy they feel is indicated.
| Study group | Role | What they receive |
|---|---|---|
| STAND | Experimental | Receives STAND intervention delivered in community mental health setting. Receives: Behavioral: STAND (Behavior Therapy + Motivational Interviewing) |
| Usual Care | Active comparator | Receives usual care from community therapists. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
School Grades
GPA
Measured: 7 months
ADHD Symptoms
Conners, ADHD Checklist
Measured: 7 months
Behavior Problems in School
Official Disciplinary Records from School District
Measured: 7 months
Academic Problems
Adolescent Academic Problems Checklist
Measured: 7 months
Parent Teen Conflict
Conflict Behavior Questionnaire, Video Interaction Tasks
Measured: 7 months
Secondary outcomes (8)
Satisfaction with Treatment
Rating Scale of Patient Satisfaction with all aspects of Treatment
Measured: 7 months
Quality of Therapeutic Relationship between the therapist and the patient
Patient report on therapeutic alliance
Measured: 7 months
Organization Skills
Direct observation of recording homework and book bag organization
Measured: 7 months
Executive Functioning
BRIEF rating scale, DKEFS, AWMA
Measured: 7 months
Motivation
Motivation (readiness) ruler, hungry donkey task, choice delay task,
Measured: 7 months
Parent academic Involvement
Parent report of academic management, number of hours spent helping, video interaction task
Measured: 7 months
parent-teen communication
video tasks
Measured: 7 months
parent readiness to change
Motivation (readiness) ruler, parent change talk
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2016 (estimated)
- Study startMay 2015
- Primary completionDec 2018
- Study completion31 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 278 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02694939
- Sponsor's protocol ID
- R01MH106587
- Acronym
- STAND
- Status last verified
- Feb 2021
- First submitted
- 24 Jul 2015
- Last updated
- 3 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Sibley MH, Graziano PA, Coxe S, Page TF, Martin P. Three-Year Effects of Motivational Interviewing-Enhanced Behavior Therapy for Adolescents With Attention-Deficit/Hyperactivity Disorder: A Randomized Community-Based Trial. J Am Acad Child Adolesc Psychiatry. 2025 Oct;64(10):1165-1178. doi: 10.1016/j.jaac.2024.10.009. Epub 2024 Oct 21.
PubMed 39442667Sibley 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.
PubMed 33988847Sibley 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.
PubMed 32861773Sibley 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.
PubMed 32103410
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of MI Enhanced Behavior Therapy for Adolescents With ADHD
- ClinicalTrials.gov ID
- NCT02694939
- Acronym / sponsor ID
- STAND / R01MH106587
- Conditions
- Attention Deficit Hyperactivity Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- Florida International UniversityUniversity, hospital or other
- Study start
- May 2015 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 1 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STAND | Experimental | Behavioral: STAND (Behavior Therapy + Motivational Interviewing)Receives STAND intervention delivered in community mental health setting. |
| Usual Care | Active comparator | Behavioral: Usual CareReceives usual care from community therapists. |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- ADHD diagnosis
- IQ of at least 70
- Enrollment in sixth through twelfth grade
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STAND (Behavior Therapy + Motivational Interviewing)Parent-teen collaborative skills based behavior therapy targeting Executive functioning and Delay Aversion in Teens | Behavioural | STAND |
| Usual CareCommunity Therapists free to deliver any therapy they feel is indicated. | Behavioural | Usual Care |
Primary outcome
School Grades
Time frame: 7 months
GPA
ADHD Symptoms
Time frame: 7 months
Conners, ADHD Checklist
Behavior Problems in School
Time frame: 7 months
Official Disciplinary Records from School District
Academic Problems
Time frame: 7 months
Adolescent Academic Problems Checklist
Parent Teen Conflict
Time frame: 7 months
Conflict Behavior Questionnaire, Video Interaction Tasks
8 secondary outcomes
Satisfaction with Treatment
Time frame: 7 months
Quality of Therapeutic Relationship between the therapist and the patient
Time frame: 7 months
Organization Skills
Time frame: 7 months
Executive Functioning
Time frame: 7 months
Motivation
Time frame: 7 months
Parent academic Involvement
Time frame: 7 months
parent-teen communication
Time frame: 7 months
parent readiness to change
Time frame: 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
- Derived from this study: PubMed 39442667Sibley MH, Graziano PA, Coxe S, Page TF, Martin P. Three-Year Effects of Motivational Interviewing-Enhanced Behavior Therapy for Adolescents With Attention-Deficit/Hyperactivity Disorder: A Randomized Community-Based Trial. J Am Acad Child Adolesc Psychiatry. 2025 Oct;64(10):1165-1178. doi: 10.1016/j.jaac.2024.10.009. Epub 2024 Oct 21.
- Derived from this study: PubMed 33988847Sibley 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.
- Derived from this study: PubMed 32861773Sibley 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.
- Derived from this study: PubMed 32103410Sibley 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STAND (Behavior Therapy + Motivational Interviewing) in people with Attention Deficit Hyperactivity Disorder, run by Florida International University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
School Grades (time frame: 7 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02694939, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2021.