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Effectiveness of a Digital Strategy-based Educational Skills Group for Secondary Students With Organization and Academic Motivation Challenges (STAND-G)

17 mei 2022 bijgewerkt door: Margaret Sibley, Seattle Children's Hospital

The purpose of this study is to test the effectiveness of a telehealth-delivered skills training versus active control group for middle and high school students with ADHD symptoms. Both programs will be delivered digitally (via Zoom).

Investigators will measure student functioning at baseline, post-group, and three-month follow-up. The primary outcomes are ADHD symptoms, student grade point average, and attendance as reported in the gradebook. Secondary outcomes include parent academic support, autonomy, academic motivation, and organization skills. Participant satisfaction with the group will be measured post-group. Group attendance and homework completion will also be measured.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

120 middle and high school students with elevated ADHD symptoms will be recruited for this study, which will take place over the course of the 2021-2022 academic year. The recruitment strategy will be to distribute information about the study opportunity to educator email lists in South Florida (see appended email template). Educators will be instructed to share information about the study to the parents of students who perceive to experience ADHD symptoms in their schools, regardless of special education status or documentation of a disability.

Students who enroll will be randomly assigned to either receive the STAND-G strategy-based group or a peer-support-based, active control group. Investigators will blind participants and their parents to which group is the active treatment by informing parents and students that participant will be randomly assigned to one of two groups to help improve school difficulties in youth. The two groups will be of equal duration, both will be led by the same instructors; and will differ only in content (teaching strategies vs. facilitating peer support and problem-solving conversations).

Students (and their parents) will complete assessments at baseline, post-group, and three months post-group. School records will be obtained for all time points.

Studietype

Ingrijpend

Inschrijving (Verwacht)

120

Fase

  • Fase 2
  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

11 jaar tot 17 jaar (Kind)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

Students will be required to,

  • be in the sixth through twelfth grade,
  • have elevated ADHD symptoms
  • documented impairment according to the SNAP
  • documented impairment according to Impairment Rating Scale.
  • Students must be 17.5 or younger at the time of enrollment to ensure that they are still under 18 at the expected completion of the study.

Parents of eligible students will also participate.

Exclusion Criteria:

Students may not be,

  • in a self-contained special education classroom,
  • possess intellectual disability
  • be non-English speaking
  • be older than 18 years old at time of enrollment

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Behavioral Parent Training/Organization Skills Training
Parents will receive 8 weeks of a 90 minute behavioral parent training protocol that focuses on supporting academic and behavioral success in adolescents with ADHD. Teens will receive a simultaneous 8 weeks of a 90 minute organization skills training group. Both groups will be delivered via telehealth.
Gedragsmatig: BPT/OST
See Arm description.
Andere namen:
  • STAND-Group
Sham-vergelijker: Peer support
Parents and teens will each participate in 8 weeks of a 90 minute peer support group focused on exchange of shared experience and group problem-solving difficulties. Both groups will be delivered via telehealth.
Gedragsmatig: Peer Support
See Arm description

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
ADHD Symptoms
Tijdsspanne: Change from Baseline through 3 months after Post-Treatment, an average of 6 months
Parent and Self Ratings on the SNAP Rating Scale
Change from Baseline through 3 months after Post-Treatment, an average of 6 months
Academic Impairment: Grade Point Average
Tijdsspanne: Change from Baseline through 3 months after Post-Treatment, an average of 6 months
Official School Records
Change from Baseline through 3 months after Post-Treatment, an average of 6 months
Academic Impairment: School Attendance
Tijdsspanne: Change from Baseline through 3 months after Post-Treatment, an average of 6 months
Official School Records
Change from Baseline through 3 months after Post-Treatment, an average of 6 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Academic Motivation
Tijdsspanne: Change from Baseline through 3 months after Post-Treatment, an average of 6 months
Expectancy-Value Questionnaire -Self Version
Change from Baseline through 3 months after Post-Treatment, an average of 6 months
Academic Motivation
Tijdsspanne: Change from Baseline through 3 months after Post-Treatment, an average of 6 months
Change Ruler -Self Version
Change from Baseline through 3 months after Post-Treatment, an average of 6 months
Executive Functions
Tijdsspanne: Change from Baseline through 3 months after Post-Treatment, an average of 6 months
BRIEF Rating Scale -Parent Version
Change from Baseline through 3 months after Post-Treatment, an average of 6 months
Organization, Time Management, and Planning
Tijdsspanne: Change from Baseline through 3 months after Post-Treatment, an average of 6 months
Adolescent Academic Problems Checklist-Parent and Self Version will be used to measure organization, time management and planning
Change from Baseline through 3 months after Post-Treatment, an average of 6 months
Parent Academic Involvement
Tijdsspanne: Change from Baseline through 3 months after Post-Treatment, an average of 6 months
Parent Academic Management Scale - Parent Version
Change from Baseline through 3 months after Post-Treatment, an average of 6 months
Academic Impairment Rating Scale
Tijdsspanne: Change from Baseline through 3 months after Post-Treatment, an average of 6 months
Impairment Rating Scale - Parent Version
Change from Baseline through 3 months after Post-Treatment, an average of 6 months
Parent-Teen Conflict
Tijdsspanne: Change from Baseline through 3 months after Post-Treatment, an average of 6 months
Conflict Behavior Questionnaire-20 - Parent, Self Version
Change from Baseline through 3 months after Post-Treatment, an average of 6 months
Goal Setting
Tijdsspanne: Change from Baseline through 3 months after Post-Treatment, an average of 6 months
Goal Setting Questionnaire- Parent and Self
Change from Baseline through 3 months after Post-Treatment, an average of 6 months
Parent Autonomy Support
Tijdsspanne: Change from Baseline through 3 months after Post-Treatment, an average of 6 months
Parent Promotion of Volitional Functioning- Self Report
Change from Baseline through 3 months after Post-Treatment, an average of 6 months

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Treatment Satisfaction
Tijdsspanne: At Post-treatment, approximately 8 weeks after initial group session
Parent and Self Report Satisfaction Survey
At Post-treatment, approximately 8 weeks after initial group session
Treatment Fidelity
Tijdsspanne: Through Treatment Completion, an average of 8 weeks
Blinded Observers will observe to code for fidelity
Through Treatment Completion, an average of 8 weeks
Treatment Barriers
Tijdsspanne: At Post-treatment, approximately 8 weeks after initial group session
Parent an Self Reported Barriers Survey
At Post-treatment, approximately 8 weeks after initial group session
Treatment Credibility
Tijdsspanne: At Post-treatment, approximately 8 weeks after initial group session
Client Credibility Questionnaire-Parent and Self
At Post-treatment, approximately 8 weeks after initial group session
Video Conferencing Feasibility
Tijdsspanne: At Post-treatment, approximately 8 weeks after initial group session
Video-Conferencing Questionnaire-Parent and Self
At Post-treatment, approximately 8 weeks after initial group session
Treatment Attendance
Tijdsspanne: Through study completion, an average of 8 weeks, at each Session of Treatment
Group records
Through study completion, an average of 8 weeks, at each Session of Treatment
Treatment Homework Completion
Tijdsspanne: Through study completion, an average of 8 weeks, at each Session of Treatment
Group records
Through study completion, an average of 8 weeks, at each Session of Treatment

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Seattle Children's Hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Verwacht)

18 mei 2022

Primaire voltooiing (Verwacht)

30 september 2022

Studie voltooiing (Verwacht)

30 september 2022

Studieregistratiedata

Eerst ingediend

24 september 2021

Eerst ingediend dat voldeed aan de QC-criteria

17 mei 2022

Eerst geplaatst (Werkelijk)

23 mei 2022

Updates van studierecords

Laatste update geplaatst (Werkelijk)

23 mei 2022

Laatste update ingediend die voldeed aan QC-criteria

17 mei 2022

Laatst geverifieerd

1 mei 2022

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • 00003308

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

We will submit data from this trial to the OSF data repository upon completion of the trial.

IPD-tijdsbestek voor delen

Within six months of the completion of the trial

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • ICF

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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