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HEARTS R34 Feasibility Study, Autistic Participants

NCT ID: NCT05608083

Last Updated: 2024-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2024-07-31

Brief Summary

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The goal of this randomized clinical trial is to test whether the 6 sessions HEARTS Healthy Relationships classes increases the satisfaction that autistic adults feel about their friendships and dating relationships compared to a 6 weeks online discussion group. The 6 HEARTS sessions cover: healthy and unhealthy relationships, launching new relationships, neurohealth, meeting and reconnecting, boundaries, and healthy endings.

Participants who take part in this research study will be in this research study for three months. During this time, participants will be asked to complete two 30-minute and six 10-minute online surveys, and participate in two 20-minute interviews over Zoom.

Detailed Description

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Conditions

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Autism Spectrum Disorder

Keywords

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Friendships Dating relationships Zoom sessions Satisfaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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HEARTS NOW

Participants in the HEARTS NOW group participants will participate in a weekly six-session online HEARTS class via Zoom about relationships.

Group Type EXPERIMENTAL

HEARTS classes

Intervention Type BEHAVIORAL

HEARTS teaches autistic adults about friendship and healthy dating relationships. HEARTS is 6-sessions long and meets weekly over zoom. Each session is 90 minutes long.

HEARTS LATER

Participants in the HEARTS LATER group will participate in a six-week online support group via Zoom about relationships. Participants in this arm will have the option of taking the HEARTS class after the study has ended.

Group Type ACTIVE_COMPARATOR

Online discussion group

Intervention Type BEHAVIORAL

A 90-minute discussion group will meet online weekly for 6 weeks to discuss friendships and healthy dating relationships for autistic adults.

Interventions

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HEARTS classes

HEARTS teaches autistic adults about friendship and healthy dating relationships. HEARTS is 6-sessions long and meets weekly over zoom. Each session is 90 minutes long.

Intervention Type BEHAVIORAL

Online discussion group

A 90-minute discussion group will meet online weekly for 6 weeks to discuss friendships and healthy dating relationships for autistic adults.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with autism by a healthcare provider or other professional
* Willing to be randomized to either HEARTS or the active control condition (ACC)
* Have not already participated in the study, nor in the HEARTS class previously
* English speaking

Exclusion Criteria

* unwilling or unable to provide informed consent by themselves
* have participated at any time previously in HEARTS research or the HEARTS class
* are unable to understand English
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role collaborator

Boston University Charles River Campus

OTHER

Sponsor Role lead

Responsible Party

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Emily Rothman

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Emily F Rothman, ScD

Role: PRINCIPAL_INVESTIGATOR

BU Sargent College, Occupational Therapy Department

Locations

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Boston University CRC

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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6800E

Identifier Type: -

Identifier Source: org_study_id