- ICH GCP
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- Klinische proef NCT02048579
Increasing Academic Success in Middle School Students With ADHD (STAND)
Broadly, the purpose of the proposed study is to test the efficacy of a parent-coordinated, parent-teen-teacher collaborative intervention for middle school students with ADHD and academic impairment (STAND; Supporting Teens' Academic Needs Daily). [This model was chosen because of its potential ability to promote treatment maintenance and generalizability across school years, because parents will be taught to implement, monitor, and adjust intervention components as needed. Key innovative components in the STAND intervention address previously reported treatment barriers: 1) a parent-delivered academic intervention to promote maintenance and generalization across school years, and to relieve some of the burden of intervention delivery from teachers, 2) motivational interviewing to address parent disengagement from and adolescent resistance to the treatment process, 3) multiple tailored options for home-school communication, including a web-based support system, to facilitate home-school communication, and 4) empowering parents by coaching them to effectively and tactfully involve teachers in the treatment planning and monitoring process in order to increase teachers' willingness to support the child's academic needs. To study the feasibility and preliminary efficacy of the STAND treatment model,] two cohorts of 42 middle school students with ADHD will be recruited (total N=84) and randomly assigned to participate in STAND or a treatment-as-usual monitoring group. All participants will complete intake, mid-treatment, post-treatment, [and follow-up] assessments designed to monitor academic functioning, [intervention feasibility, compliance, and satisfaction].
Aim 1: The proposed study will evaluate the efficacy, [maintenance, and cross-school year generalization] of a parent-teen-teacher collaborative intervention (Supporting Teens' Academic Needs Daily; STAND) vs. treatment as usual to increase the academic functioning of middle school students with ADHD. Intervention effects on ADHD symptomatology and impairment, grade-point-average (GPA), [organization, daily planner use], homework completion, teacher ratings of academic functioning and classroom behavior, and the parent-teen relationship will be examined.
Aim 2: The proposed study will examine the acceptability and feasibility of the STAND program. Parents and teens will report on [satisfaction, barriers to treatment participation, therapeutic alliance, and treatment credibility] throughout the intervention and follow-up period. [Therapists will also complete ratings of parent and adolescent engagement and compliance with treatment procedures] will be collected from participants in the program. Parent, teen, and teacher compliance with intervention procedures will also be measured in order to assess feasibility. Treatment fidelity measures will also be collected in order to measure clinician adherence to the manualized STAND procedures.
Aim 3: The proposed study will also explore ways to improve home-school communication during the middle school years. To this end, families will be given options regarding the modality of communication with teachers, and parent, teen, and teacher preferences for medium of intervention delivery will be examined (i.e., web-based, email, paper/pencil).
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- DSM-IV-TR ADHD Diagnosis; regular education placement in school; academic impairment
Exclusion Criteria:
- IQ<80; Autism or PDD diagnosis;
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Faculteitstoewijzing
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Geen tussenkomst: Behandeling zoals gebruikelijk
|
|
Experimenteel: Behavior Therap + Motivational Interviewing
Supporting Teens' Academic Needs Daily Therapy program delivered to parents and teens
|
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Grade Point Average
Tijdsspanne: One year
|
One year
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Parent Rated Adolescent Academic Problems
Tijdsspanne: One Year
|
One Year
|
parent rated ADHD symptoms
Tijdsspanne: one year
|
one year
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Margaret H Sibley, Ph.D., Florida International University
- Hoofdonderzoeker: Willam Pelham, Ph.D., Florida International University
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- R34MH092466-01A1 (Subsidie/contract van de Amerikaanse NIH)
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
product vervaardigd in en geëxporteerd uit de V.S.
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