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AccommodationNCT07572110

Project Independence

A study testing Project Independence in people with Accommodation and Daily Activities, run by University of Miami at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Accommodation, Daily Activities, Independence
What is being tested?
Project Independence
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteUnited States
Study dates
8 May 2026to Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • Adults unable to consent
  • Individuals who are not yet adults (i.e., infants, children, teenagers).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sandra L Cepeda, M.S. contact

305-284-2712 ext. ext. 1

slc247@miami.edu

United States1 site, 1 recruiting

  • University of Miami

    Coral Gables, Florida, 33146

    Sandra L Cepeda, M.S., 305-284-2712, slc247@miami.edu

    Jill Ehrenreich-May, Ph.D.

    Recruiting

Other trials in United States

About this study

Official title: 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.

Being tested
Project Independence
Medical subject headings
Autistic Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Project IndependenceBehavioural

    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.

Study groups in NCT07572110
Study groupRoleWhat they receive
Project Independence Immediately (Single-Session Intervention group)ExperimentalParticipants assigned to this arm will complete an online single-session intervention (SSI), with an estimated completion time of 30-minutes.
Receives: Behavioral: Project Independence
Attention Control GroupNo interventionParticipants in this arm will view a series of online educational videos unrelated to the intervention content, lasting approximately 30-minutes.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Perceived Change in Caregiver Confidence

    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.

    Measured: Baseline (pre-intervention), immediately post-intervention (same session)

Secondary outcomes (3)

  1. Perceived Change in Caregiver Accommodation

    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.

    Measured: Immediately post-intervention, 2-week follow-up

  2. Perceived Change in Opportunities for Youth Practice in Independence

    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.

    Measured: Immediately post-intervention, 2-week follow-up

  3. Program Feedback Scale (PFS)

    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.

    Measured: Immediately post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2026
  2. Study start8 May 2026
  3. Primary completionMay 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07572110
Sponsor's protocol ID
20260208
Status last verified
May 2026
First submitted
30 Apr 2026
Last updated
19 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 34255718

  • 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.

    PubMed 33796139

  • 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.

    PubMed 33835354

  • 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.

    PubMed 31799863

  • 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.

    PubMed 36925822

Questions about this trial

What is this clinical trial studying?

A study testing Project Independence in people with Accommodation and Daily Activities, run by University of Miami at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sandra L Cepeda, M.S. (305-284-2712 ext. ext. 1, slc247@miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Perceived Change in Caregiver Confidence (time frame: Baseline (pre-intervention), immediately post-intervention (same session)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07572110, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.

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