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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a six-session online class called HEARTS Healthy Relationships can enhance satisfaction in friendships and dating relationships for autistic adults, compared to a regular online discussion group. The HEARTS sessions cover topics such as healthy and unhealthy relationships, initiating new connections, understanding neurohealth, setting boundaries, and ending relationships amicably. Participants will complete online surveys and participate in Zoom interviews over three months. Autistic adults diagnosed by a professional and comfortable with online sessions in English may be suitable for this study. As an unphased study, this trial provides a unique opportunity to explore and improve personal relationships in a supportive environment.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the HEARTS Healthy Relationships classes are safe for autistic adults?

Research has shown that the HEARTS Healthy Relationships classes have been tested with autistic adults to assess their effectiveness and practicality. In these studies, participants handled the classes well, and no serious side effects occurred. Most participants found the sessions interesting and helpful. This indicates that the classes are safe for autistic adults, as no reports of harm or negative effects have emerged from attending. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the HEARTS Healthy Relationships classes for autism because they offer a unique approach to enhancing social skills through structured, relationship-focused sessions. Unlike traditional autism therapies that often emphasize behavioral interventions, HEARTS classes provide an online platform for individuals to engage in real-time discussions about relationships, fostering practical skills in a supportive environment. Additionally, the option to participate in either the immediate HEARTS NOW sessions or the HEARTS LATER support group followed by the class offers flexibility and inclusivity, catering to different participant needs and schedules.

What evidence suggests that the HEARTS Healthy Relationships classes could be effective for improving relationship satisfaction in autistic adults?

Research shows that the HEARTS Healthy Relationships classes can help autistic adults feel happier with their friendships and dating relationships. In this trial, participants in the HEARTS NOW group will attend a weekly six-session online HEARTS class via Zoom about relationships. A study tested this six-session online class with autistic individuals aged 18–44 and found it practical and initially beneficial. Participants reported noticeable improvements in depression and anxiety after completing the program. This suggests that learning about relationships in a structured way can enhance social interactions for autistic individuals. The program covers important topics like setting boundaries and healthy communication, which could improve relationship satisfaction. Meanwhile, participants in the HEARTS LATER group will join a six-week online support group via Zoom about relationships, with the option to take the HEARTS class after the study concludes. ^{1 2 4 6 7}

Who Is on the Research Team?

Emily F Rothman, ScD

Principal Investigator

BU Sargent College, Occupational Therapy Department

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8934295/

Healthy Relationships on the Autism Spectrum (HEARTS) This study tested the feasibility and preliminary efficacy of a six-session online class on healthy relationships for autistic individuals ages 18–44 years old.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8665942/

Using formative research to develop HEARTS The purpose of this formative research study was to describe the views of autistic youth about healthy and unhealthy friendships and dating relationships.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05608083

HEARTS R34 Feasibility Study, Autistic Participants The goal of this randomized clinical trial is to test whether the 6 sessions HEARTS Healthy Relationships classes increases the satisfaction that autistic ...

4. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/13623613211069421

Healthy Relationships on the Autism Spectrum (HEARTS) This study tested the feasibility and preliminary efficacy of a six-session online class on healthy relationships for autistic individuals ages 18–44 years old.

5. researchgate.net researchgate.net/publication/357703396_Healthy_Relationships_on_the_Autism_Spectrum_HEARTS_A_feasibility_test_of_an_online_class_co-designed_and_co-taught_with_autistic_people

Healthy Relationships on the Autism Spectrum (HEARTS) Results: Fifty-five participants completed the intervention. Postintervention scores revealed statistically significant improvements in depression and anxiety.

6. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/13623613211024521

Using formative research to develop HEARTS The purpose of this formative research study was to describe the views of autistic youth about healthy and unhealthy friendships and dating relationships.

7. aane.org aane.org/events/online-closed-12-part-workshop-healthy-relationships-on-the-autism-spectrum-hearts-for-adults-4-25-24-8-22-24-715-pm-845-pm-et/

Healthy Relationships on The Autism Spectrum (HEARTS) ... HEARTS is a 12 session workshop for Autistic adults who would like to learn about, and talk about, healthy friendship and dating relationships.