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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 maj 2022 uppdaterad av: 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Förväntat)

120

Fas

  • Fas 2
  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

11 år till 17 år (Barn)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Beteende: BPT/OST
See Arm description.
Andra namn:
  • STAND-Group
Sham Comparator: 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.
Beteende: Peer Support
See Arm description

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
ADHD Symptoms
Tidsram: 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
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Academic Motivation
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Treatment Satisfaction
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Seattle Children's Hospital

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Förväntat)

18 maj 2022

Primärt slutförande (Förväntat)

30 september 2022

Avslutad studie (Förväntat)

30 september 2022

Studieregistreringsdatum

Först inskickad

24 september 2021

Först inskickad som uppfyllde QC-kriterierna

17 maj 2022

Första postat (Faktisk)

23 maj 2022

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

23 maj 2022

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

17 maj 2022

Senast verifierad

1 maj 2022

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • 00003308

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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

Tidsram för IPD-delning

Within six months of the completion of the trial

IPD-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV
  • ICF

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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