- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07572110
Project Independence
14. maj 2026 opdateret af: Jill May Ehrenreich, University of Miami
The Development and Evaluation of an Online, Caregiver-Directed Single Session Intervention for Building Independence in Daily Living Skills in Autistic Youth
This project aims to develop and test the feasibility, acceptability, and preliminary impact of a brief, online single-session intervention (SSI) for caregivers of autistic youth ages 10 to 14.
The SSI, called Project Independence, is designed to give caregivers practical tools to support greater independence in daily living routines.
To test the SSI, participants will be randomly assigned to either complete Project Independence or watch a time-matched, series of educational video with unrelated content.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
70
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Sandra L Cepeda, M.S.
- Telefonnummer: ext. 1 305-284-2712
- E-mail: slc247@miami.edu
Studiesteder
-
-
Florida
-
Coral Gables, Florida, Forenede Stater, 33146
- Rekruttering
- University of Miami
-
Ledende efterforsker:
- Jill Ehrenreich-May, Ph.D.
-
Kontakt:
- Sandra L Cepeda, M.S.
- Telefonnummer: 305-284-2712
- E-mail: slc247@miami.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
- Ældre voksen
Tager imod sunde frivillige
Ja
Beskrivelse
Inclusion Criteria:
- Any adult (age 18+) who is a parent, family member, or legal caregiver and is one of the main adults responsible for the daily care of an autistic youth in the targeted age range for at least half of the time.
- Those that currently reside in the United States
- Those that have a mobile device (e.g., laptop, tablet, smartphone) or desktop computer and internet access sufficient for the delivery of the study assessments and online intervention
- Those who may or may not report current clinically significant psychopathological symptoms (e.g., anxiety, depression, parental stress).
Exclusion Criteria:
- Adults unable to consent
- Individuals who are not yet adults (i.e., infants, children, teenagers).
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Project Independence Immediately (Single-Session Intervention group)
Participants assigned to this arm will complete an online single-session intervention (SSI), with an estimated completion time of 30-minutes.
|
Participants will complete a self-guided, online, single-session digital intervention delivered through interactive audiovisual content.
The intervention includes guided readings related to caregiving and independence, brief demonstration stories or videos, and structured reflection or brainstorming activities, lasting approximately 30 minutes.
|
|
Ingen indgriben: Attention Control Group
Participants in this arm will view a series of online educational videos unrelated to the intervention content, lasting approximately 30-minutes.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Perceived Change in Caregiver Confidence
Tidsramme: Baseline (pre-intervention), immediately post-intervention (same session)
|
Caregivers will rate their perceived confidence in their ability to support their child in building independence in daily living skills using an 11-point rating scale (developed for the purpose of this study), from 0 ("Not at All Confident") to 10 ("Extremely Confident").
Higher ratings on this item indicate greater perceived confidence to support youth independence in daily living skills.
|
Baseline (pre-intervention), immediately post-intervention (same session)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Perceived Change in Caregiver Accommodation
Tidsramme: Immediately post-intervention, 2-week follow-up
|
Caregivers will rate the extent to which they provided accommodation in the past week when the identified daily living skills was being completed using an 11-point rating scale (developed for the purpose of this study), from 0 ("Not at all") to 10 ("Completely").
Higher ratings on this item indicate greater perceived accommodation use in the identified daily routine.
|
Immediately post-intervention, 2-week follow-up
|
|
Perceived Change in Opportunities for Youth Practice in Independence
Tidsramme: Immediately post-intervention, 2-week follow-up
|
Caregivers will rate how often they provided opportunities for their child to practice the identified daily living skill independently using an 11-point rating scale (developed for the purpose of this study), from 0 ("Never") to 10 ("Almost Always").
Higher ratings on this item indicate greater perceived opportunities provided to youth to practice independence the identified daily routine.
|
Immediately post-intervention, 2-week follow-up
|
|
Program Feedback Scale (PFS)
Tidsramme: Immediately post-intervention
|
Participants will complete the Program Feedback Scale (PFS), an 8 item validated self report measure assessing perceived acceptability and feasibility of the intervention.
Items are rated on a 5 point Likert scale ranging from 1 ("Really disagree") to 5 ("Really agree"), with higher scores indicating greater perceived acceptability and feasibility.
|
Immediately post-intervention
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Jill Ehrenreich-May, Ph.D., University of Miami
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.
Generelle publikationer
- Schleider JL, Dobias ML, Sung JY, Mullarkey MC. Future Directions in Single-Session Youth Mental Health Interventions. J Clin Child Adolesc Psychol. 2020 Mar-Apr;49(2):264-278. doi: 10.1080/15374416.2019.1683852. Epub 2019 Dec 4.
- Schleider JL, Beidas RS. Harnessing the Single-Session Intervention approach to promote scalable implementation of evidence-based practices in healthcare. Front Health Serv. 2022 Sep 23;2:997406. doi: 10.3389/frhs.2022.997406. eCollection 2022.
- Anvari, F., & Lakens, D. (2021). Using anchor-based methods to determine the smallest effect size of interest. Journal of Experimental Social Psychology, 96, 104159.
- Sung JY, Mumper E, Schleider JL. Empowering Anxious Parents to Manage Child Avoidance Behaviors: Randomized Control Trial of a Single-Session Intervention for Parental Accommodation. JMIR Ment Health. 2021 Jul 6;8(7):e29538. doi: 10.2196/29538.
- Baker E, Stavropoulos KKM, Baker BL, Blacher J. Daily living skills in adolescents with autism spectrum disorder: Implications for intervention and independence. Res Autism Spectr Disord. 2021 May;83:101761. doi: 10.1016/j.rasd.2021.101761. Epub 2021 Mar 5.
- Duncan A, Meinzen-Derr J, Ruble LA, Fassler C, Stark LJ. A Pilot Randomized Controlled Trial of a Daily Living Skills Intervention for Adolescents with Autism. J Autism Dev Disord. 2022 Feb;52(2):938-949. doi: 10.1007/s10803-021-04993-y. Epub 2021 Apr 9.
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)
8. maj 2026
Primær færdiggørelse (Anslået)
1. maj 2027
Studieafslutning (Anslået)
1. december 2027
Datoer for studieregistrering
Først indsendt
30. april 2026
Først indsendt, der opfyldte QC-kriterier
30. april 2026
Først opslået (Faktiske)
7. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
19. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
14. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 20260208
Plan for individuelle deltagerdata (IPD)
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