NCT02694939

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
278

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2015

Completed
7 months until next milestone

First Posted

Study publicly available on registry

March 1, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2020

Completed
Last Updated

February 3, 2021

Status Verified

February 1, 2021

Enrollment Period

3.6 years

First QC Date

July 24, 2015

Last Update Submit

February 2, 2021

Conditions

Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (5)

  • School Grades

    GPA

    7 months

  • ADHD Symptoms

    Conners, ADHD Checklist

    7 months

  • Behavior Problems in School

    Official Disciplinary Records from School District

    7 months

  • Academic Problems

    Adolescent Academic Problems Checklist

    7 months

  • Parent Teen Conflict

    Conflict Behavior Questionnaire, Video Interaction Tasks

    7 months

Secondary Outcomes (8)

  • Satisfaction with Treatment

    7 months

  • Quality of Therapeutic Relationship between the therapist and the patient

    7 months

  • Organization Skills

    7 months

  • Executive Functioning

    7 months

  • Motivation

    7 months

  • +3 more secondary outcomes

Study Arms (2)

STAND

EXPERIMENTAL

Receives STAND intervention delivered in community mental health setting.

Behavioral: STAND (Behavior Therapy + Motivational Interviewing)

Usual Care

ACTIVE COMPARATOR

Receives usual care from community therapists.

Behavioral: Usual Care

Interventions

STAND (Behavior Therapy + Motivational Interviewing)BEHAVIORAL

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

STAND
Usual CareBEHAVIORAL

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

Usual Care

Eligibility Criteria

Age11 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • ADHD diagnosis
  • IQ of at least 70
  • Enrollment in sixth through twelfth grade

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Florida International University

Miami, Florida, 33199, United States

Location

Related Publications (4)

  • 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.

    PMID: 39442667DERIVED

  • 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.

    PMID: 33988847DERIVED

  • 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.

    PMID: 32861773DERIVED

  • 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.

    PMID: 32103410DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Behavior TherapyMotivational Interviewing

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and ActivitiesDirective CounselingCounselingMental Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2015

First Posted

March 1, 2016

Study Start

May 1, 2015

Primary Completion

December 1, 2018

Study Completion

October 31, 2020

Last Updated

February 3, 2021

Record last verified: 2021-02

Locations

US(1)