- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02694939
STAND Community Trial (STAND)
2. februar 2021 opdateret af: Florida International University
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
278
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Florida
-
Miami, Florida, Forenede Stater, 33199
- Florida International University
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
11 år til 17 år (Barn)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: STAND
Receives STAND intervention delivered in community mental health setting.
|
Parent-teen collaborative skills based behavior therapy targeting Executive functioning and Delay Aversion in Teens
|
|
Aktiv komparator: Usual Care
Receives usual care from community therapists.
|
Community Therapists free to deliver any therapy they feel is indicated.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
School Grades
Tidsramme: 7 months
|
GPA
|
7 months
|
|
ADHD Symptoms
Tidsramme: 7 months
|
Conners, ADHD Checklist
|
7 months
|
|
Behavior Problems in School
Tidsramme: 7 months
|
Official Disciplinary Records from School District
|
7 months
|
|
Academic Problems
Tidsramme: 7 months
|
Adolescent Academic Problems Checklist
|
7 months
|
|
Parent Teen Conflict
Tidsramme: 7 months
|
Conflict Behavior Questionnaire, Video Interaction Tasks
|
7 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Satisfaction with Treatment
Tidsramme: 7 months
|
Rating Scale of Patient Satisfaction with all aspects of Treatment
|
7 months
|
|
Quality of Therapeutic Relationship between the therapist and the patient
Tidsramme: 7 months
|
Patient report on therapeutic alliance
|
7 months
|
|
Organization Skills
Tidsramme: 7 months
|
Direct observation of recording homework and book bag organization
|
7 months
|
|
Executive Functioning
Tidsramme: 7 months
|
BRIEF rating scale, DKEFS, AWMA
|
7 months
|
|
Motivation
Tidsramme: 7 months
|
Motivation (readiness) ruler, hungry donkey task, choice delay task,
|
7 months
|
|
Parent academic Involvement
Tidsramme: 7 months
|
Parent report of academic management, number of hours spent helping, video interaction task
|
7 months
|
|
parent-teen communication
Tidsramme: 7 months
|
video tasks
|
7 months
|
|
parent readiness to change
Tidsramme: 7 months
|
Motivation (readiness) ruler, parent change talk
|
7 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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.
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. maj 2015
Primær færdiggørelse (Faktiske)
1. december 2018
Studieafslutning (Faktiske)
31. oktober 2020
Datoer for studieregistrering
Først indsendt
24. juli 2015
Først indsendt, der opfyldte QC-kriterier
24. februar 2016
Først opslået (Skøn)
1. marts 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
3. februar 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. februar 2021
Sidst verificeret
1. februar 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- R01MH106587 (U.S. NIH-bevilling/kontrakt)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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