Project Independence

May 14, 2026 updated by: 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Sandra L Cepeda, M.S.
  • Phone Number: ext. 1 305-284-2712
  • Email: slc247@miami.edu

Study Locations

  • United States
    • Florida
      • Coral Gables, Florida, United States, 33146
        • Recruiting
        • University of Miami
        • Principal Investigator:
          • Jill Ehrenreich-May, Ph.D.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: Project Independence
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.
No Intervention: Attention Control Group
Participants in this arm will view a series of online educational videos unrelated to the intervention content, lasting approximately 30-minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perceived Change in Caregiver Confidence
Time Frame: 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)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perceived Change in Caregiver Accommodation
Time Frame: 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
Time Frame: 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)
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Investigators

  • Principal Investigator: Jill Ehrenreich-May, Ph.D., University of Miami

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 8, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

April 30, 2026

First Submitted That Met QC Criteria

April 30, 2026

First Posted (Actual)

May 7, 2026

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 14, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20260208

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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