Project Independence: Randomized Controlled Trial

NCT07572110 | Not Yet Recruiting

• 1 other identifier: 20260208
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Accommodation; Daily Activities; Independence; Autism

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (3)

• Perceived Change in Caregiver Accommodation

  Immediately post-intervention, 2-week follow-up

• Perceived Change in Opportunities for Youth Practice in Independence

  Immediately post-intervention, 2-week follow-up

• Program Feedback Scale (PFS)

  Immediately post-intervention

Study Arms (2)

Project Independence Immediately (Single-Session Intervention group)

EXPERIMENTAL

Participants assigned to this arm will complete an online single-session intervention (SSI), with an estimated completion time of 30-minutes.

Behavioral: Project Independence

Attention Control Group

NO INTERVENTION

Participants in this arm will view a series of online educational videos unrelated to the intervention content, lasting approximately 30-minutes.

Interventions

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.

Project Independence Immediately (Single-Session Intervention group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Coral Gables, Florida, 33146, United States

Location

Related Publications (6)

• Anvari, F., & Lakens, D. (2021). Using anchor-based methods to determine the smallest effect size of interest. Journal of Experimental Social Psychology, 96, 104159.

  BACKGROUND

• 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.

  PMID: 34255718 BACKGROUND

• 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.

  PMID: 33796139 BACKGROUND

• 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.

  PMID: 33835354 BACKGROUND

• 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.

  PMID: 31799863 BACKGROUND

• 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.

  PMID: 36925822 BACKGROUND

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Jill Ehrenreich-May, Ph.D.

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sandra L Cepeda, M.S.

CONTACT

305-284-2712; slc247@miami.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: May 7, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 7, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)