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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

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.

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.

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

Andre undersøgelses-id-numre

  • R01MH106587 (U.S. NIH-bevilling/kontrakt)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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