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HEARTS Classes for Autism (HEARTS-R34 Trial)
N/A
Waitlist Available
Led By Emily F Rothman, ScD
Research Sponsored by Boston University Charles River Campus
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Summary
This trial tests if HEARTS classes improve relationship satisfaction for autistic adults compared to an online discussion group. Participants complete surveys and interviews over 3 months.
Who is the study for?
This trial is for English-speaking adults diagnosed with autism by a healthcare provider. Participants must be open to being randomly placed in either the HEARTS class or an online discussion group, and should not have taken part in the study or HEARTS classes before.
What is being tested?
The study compares two methods: a 'HEARTS Healthy Relationships' class covering various relationship topics over six sessions, versus a six-week online discussion group. The goal is to see which improves satisfaction with friendships and dating relationships among autistic adults.
What are the potential side effects?
Since this trial involves educational interventions rather than medical treatments, traditional physical side effects are not expected. However, participants may experience emotional discomfort when discussing personal topics related to relationships.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in engaging in perspective-taking related to rejection at 12 weeks
Change in engaging in perspective-taking related to rejection at 6 weeks
Change in motivation to interact socially at 12 weeks
+5 moreSecondary study objectives
Participant feelings of acceptability of study intervention
Participant rating of content acceptability
Participant satisfaction with study participation
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: HEARTS NOWExperimental Treatment1 Intervention
Participants in the HEARTS NOW group participants will participate in a weekly six-session online HEARTS class via Zoom about relationships.
Group II: HEARTS LATERActive Control1 Intervention
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.
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Who is running the clinical trial?
Boston University Charles River CampusLead Sponsor
118 Previous Clinical Trials
12,368 Total Patients Enrolled
5 Trials studying Autism Spectrum Disorder
276 Patients Enrolled for Autism Spectrum Disorder
University of Alabama at BirminghamOTHER
1,621 Previous Clinical Trials
2,290,883 Total Patients Enrolled
7 Trials studying Autism Spectrum Disorder
1,017 Patients Enrolled for Autism Spectrum Disorder
Boston UniversityLead Sponsor
467 Previous Clinical Trials
9,954,173 Total Patients Enrolled
3 Trials studying Autism Spectrum Disorder
145 Patients Enrolled for Autism Spectrum Disorder
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing to be assigned to any treatment group in the study.
Research Study Groups:
This trial has the following groups:- Group 1: HEARTS NOW
- Group 2: HEARTS LATER
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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