← Back to Search

HEARTS Classes for Autism (HEARTS-R34 Trial)

N/A

Recruiting

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

HEARTS-R34 Trial 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.Check my eligibility

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.See study design

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.

HEARTS-R34 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 more

Secondary outcome measures

Participant feelings of acceptability of study intervention

Participant rating of content acceptability

Participant satisfaction with study participation

+1 more

HEARTS-R34 Trial 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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Boston University Charles River CampusLead Sponsor

114 Previous Clinical Trials

12,230 Total Patients Enrolled

5 Trials studying Autism Spectrum Disorder

276 Patients Enrolled for Autism Spectrum Disorder

University of Alabama at BirminghamOTHER

1,590 Previous Clinical Trials

2,281,602 Total Patients Enrolled

6 Trials studying Autism Spectrum Disorder

967 Patients Enrolled for Autism Spectrum Disorder

Boston UniversityLead Sponsor

455 Previous Clinical Trials

9,941,565 Total Patients Enrolled

3 Trials studying Autism Spectrum Disorder

145 Patients Enrolled for Autism Spectrum Disorder

Media Library

HEARTS Healthy Relationships classes Clinical Trial Eligibility Overview. Trial Name: NCT05608083 — N/A

Autism Spectrum Disorder Research Study Groups: HEARTS NOW, HEARTS LATER

Autism Spectrum Disorder Clinical Trial 2023: HEARTS Healthy Relationships classes Highlights & Side Effects. Trial Name: NCT05608083 — N/A

HEARTS Healthy Relationships classes 2023 Treatment Timeline for Medical Study. Trial Name: NCT05608083 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial currently recruiting participants?

"Clinicaltrials.gov currently states that this clinical trial is recruiting participants, with the initial posting occuring on February 1st 2023 and the most recent update being August 30th 2023."

Answered by AI

How many participants are being accepted to take part in this experiment?

"Affirmative. Clinicaltrials.gov reveals that this clinical trial, which was initially posted on February 1st 2023, is currently recruiting patients. Approximately 60 participants must be recruited from a single site."

Answered by AI

What are the primary objectives of this experiment?

"This trial, which will be monitored over a baseline and 6 week period, intends to measure the shift in perspective-taking related to rejection at the end of the 6 weeks. Secondary objectives include Teacher satisfaction ratings with an associated 3 item survey (PESS) ranging from 0-3 (with higher scores being more favourable), Participant contentment with study participation - measured via 2 items rated 1-10 where 10 is highest approval, and Participant acceptance of intervention as gauged by means of a self report 3 item scale also scored on a range between 1 and 10."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

HEARTS R34 Feasibility Study, Autistic Participants

Emily Rothman 2023. "HEARTS R34 Feasibility Study, Autistic Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05608083.

All > Autism Boston