- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07682753
MH-POWER for College Students on the Spectrum
2. september 2026 opdateret af: Wen-Pin Chang, University of Texas Rio Grande Valley
Empowering Autistic College Students: Mental Health Skill Building at a Hispanic-Serving Institution
The purpose of this project is to determine the feasibility and preliminary efficacy of a mental health skill-building and empowerment program (MH-POWER) for college students on the autism spectrum facing stress, anxiety, and depression.
The program, grounded in cognitive behavioral therapy (CBT), acceptance and commitment therapy (ACT), and habit formation, will be implemented through weekly sessions and daily practice over 8 weeks.
To evaluate the program's preliminary efficacy, we will measure mental health symptoms at baseline, mid-point, post-intervention, and one-month follow-up.
Positive outcomes could lead to scalable interventions.
Studieoversigt
Status
Rekruttering
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
30
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Wen-Pin Chang, PhD
- Telefonnummer: 9566656405
- E-mail: wenpin.chang@utrgv.edu
Studiesteder
-
-
Texas
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Edinburg, Texas, Forenede Stater, 78539
- Rekruttering
- Department of Occupational Therapy, ESWOT Building, University of Texas Rio Grande Valley
-
Kontakt:
- Wen-Pin Chang
- Telefonnummer: 9566654605
- E-mail: wenpin.chang@utrgv.edu
-
-
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
- Voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria
- College students at The University of Texas Rio Grande Valley
- age 18-30 years
- self-reported autism diagnosis confirmed via Social Responsiveness Scale-2nd Edition, the gold standard to assess impairment in adults on the autism spectrum
- elevated stress, anxiety (worry, feeling overwhelmed), or depression (feeling down), confirmed using highly reliable and validated screening tools; Patient Health Questionnaire-9, General Anxiety Disorder-7, Kessler Psychological Distress Scale-10
- not currently receiving intensive psychological treatment or psychiatric medication adjustments
- must be able to speak and read English
- willing to participate in an 8-week intervention study
Exclusion criteria:
- None
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: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: The MH-POWER program
|
The MH-POWER program is an 8-week, structured, and manualized program to improve mental health skills.
The program design consists of weekly 60-minute group sessions (8-12 in each group) and daily structured practice activities to reinforce the skills learned in each session.
Based on the Self-Regulation Framework, the MH-POWER program systematically integrates (a) CBT with a specific focus on cognitive restructuring and behavioral activation; (b) ACT with mindfulness, acceptance strategies, and values clarification; and (c) the science of habit formation, which includes action planning, goal setting, prompts, and self-monitoring.
The program focuses on developing greater relationships between thoughts, emotions, and behaviors, as well as the ability to cope effectively.
The focus areas of development include learning how thoughts create emotions and influence actions, developing a positive mindset, enhancing stress management and coping skills, employing structured problem
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Perceived Stress Scale (PSS)
Tidsramme: It will be administered at baseline (Week 0), mid-intervention (Week 4), post-intervention (Week 8), and follow-up (Week 12)
|
Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress
|
It will be administered at baseline (Week 0), mid-intervention (Week 4), post-intervention (Week 8), and follow-up (Week 12)
|
|
State-Trait Anxiety Inventory (STAI)
Tidsramme: It will be administered at baseline (Week 0), mid-intervention (Week 4), post-intervention (Week 8), and follow-up (Week 12)
|
Each subscale yields a score between 20 and 80, with higher scores indicating greater severity of anxiety.
|
It will be administered at baseline (Week 0), mid-intervention (Week 4), post-intervention (Week 8), and follow-up (Week 12)
|
|
Beck Depression Inventory-II (BDI-II)
Tidsramme: It will be administered at baseline (Week 0), mid-intervention (Week 4), post-intervention (Week 8), and follow-up (Week 12)
|
Score ranges from 0-63.
Higher scores indicate more severe depressive symptoms
|
It will be administered at baseline (Week 0), mid-intervention (Week 4), post-intervention (Week 8), and follow-up (Week 12)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Self-Reported Habit Index (SRHI)
Tidsramme: It will be administered at baseline (Week 0), mid-intervention (Week 4), post-intervention (Week 8), and follow-up (Week 12).
|
Averaged scores of all items range from 1 to 7, a higher score indicates that the behavior functions as a strong, automatic habit
|
It will be administered at baseline (Week 0), mid-intervention (Week 4), post-intervention (Week 8), and follow-up (Week 12).
|
|
Mental Health Quality of Life Questionnaire (MHQoL)
Tidsramme: It will be administered at baseline (Week 0), mid-intervention (Week 4), post-intervention (Week 8), and follow-up (Week 12).
|
Scores range from 0 to 21, with higher scores indicating better quality of life
|
It will be administered at baseline (Week 0), mid-intervention (Week 4), post-intervention (Week 8), and follow-up (Week 12).
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
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. juli 2026
Primær færdiggørelse (Anslået)
30. juni 2027
Studieafslutning (Anslået)
30. juni 2027
Datoer for studieregistrering
Først indsendt
26. juni 2026
Først indsendt, der opfyldte QC-kriterier
26. juni 2026
Først opslået (Faktiske)
6. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
3. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. september 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IRB-26-0155
Plan for individuelle deltagerdata (IPD)
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