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NCT Number: NCT07572110

Project Independence

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.

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Key information

Conditions

Accommodation Autism Autism Spectrum Disorder Autistic Disorder Child Development Disorders, Pervasive Daily Activities Independence Mental Disorders Neurodevelopmental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Coral Gables, Florida, 33146, United States

Location status: Recruiting

Location contact

Jill Ehrenreich-May, Ph.D.

PRINCIPAL_INVESTIGATOR

Sandra L Cepeda, M.S.

CONTACT

[email protected]

305-284-2712

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Project Independence

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sandra L Cepeda, M.S.

CONTACT

[email protected]

305-284-2712 ext. ext. 1

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

The Development and Evaluation of an Online, Caregiver-Directed Single Session Intervention for Building Independence in Daily Living Skills in Autistic Youth

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 7, 2026
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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