HEARTS Classes for Autism

(HEARTS-R34 Trial)

Overseen By Emily F Rothman, ScD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Boston University Charles River Campus

Disqualifiers: Non-English speakers, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 6 weeks

92 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Emily F Rothman, ScD

Principal Investigator

BU Sargent College, Occupational Therapy Department

Eligibility Criteria

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.

Inclusion Criteria

English speaking

Have not already participated in the study, nor in the HEARTS class previously

I am willing to be assigned to any treatment group in the study.

Exclusion Criteria

None other than does not meet inclusion

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in either a six-session HEARTS class or a six-week online discussion group about relationships

6 weeks

6 sessions (online)

Follow-up

Participants are monitored for changes in perspective-taking, resilience, and satisfaction with relationships

6 weeks

2 interviews (online), multiple surveys

Treatment Details

Interventions

• HEARTS Healthy Relationships classes
• Online discussion group

Trial Overview 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.

Participant Groups

Group I: HEARTS NOW Experimental Treatment 1 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 LATER Active Control 1 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.

Who Is Running the Clinical Trial?

Boston University Charles River Campus

Lead Sponsor

Trials

125

Recruited

14,100+

Boston University

Lead Sponsor

Trials

494

Recruited

9,998,000+

University of Alabama at Birmingham

Collaborator

Trials

1,677

Recruited

2,458,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+