STAND Community Trial

Not Applicable

Completed

• Conditions: Attention Deficit Hyperactivity Disorder
• Interventions: Behavioral: STAND (Behavior Therapy + Motivational Interviewing); Behavioral: Usual Care

• Registration Number: NCT02694939
• Lead Sponsor: Florida International University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-07-24
• Study First Submitted QC: 2016-02-24
• Study First Posted: 2016-03-01
• Primary Completion: 2018-12
• Study Completion: 2020-10-31
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-02
• Last Update Posted: 2021-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 278

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
STAND	STAND (Behavior Therapy + Motivational Interviewing)	Receives STAND intervention delivered in community mental health setting.
Usual Care	Usual Care	Receives usual care from community therapists.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Florida International University; 🇺🇸 Miami, Florida, United States