HEARTS R34 Feasibility Study, Autistic Participants (HEARTS-R34)

Healthy Relationships on the Autism Spectrum: Feasibility and Target Engagement

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.

Study Overview

• Status: Completed
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Behavioral: HEARTS classes; Behavioral: Online discussion group

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Boston University CRC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HEARTS NOW; Participants in the HEARTS NOW group participants will participate in a weekly six-session online HEARTS class via Zoom about relationships.	Behavioral: 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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hostile Automatic Thoughts (HATS)	The 25-item Hostile Automatic Thoughts (HAT) Scale is a self-report measure that assesses participants' ability to engage in perspective-taking related to perceived rejection and the extent to which they attribute hostile intentions to a person given an ambiguous situation. Completed by participant. For each item participants will select either: often, sometimes, or never. Higher scores are associated with higher levels of perceived rejection. Scale minimum possible score of 25, scale maximum possible score of 125. A higher score is less desirable and indicates more Hostile Automatic Thoughts.	baseline, 12 weeks
Rejection Sensitivity Questionnaire	The Rejection Sensitivity Questionnaire (RSQ), a 10-item self-report measure that assesses participants' capacity to be resilient when experiencing social rejection such as sending a text message and not getting a reply. Lower scores are associated with more resilience given rejection and thus are desirable. The minimum possible score is 20 and the maximum possible score is 720.	baseline, 12 weeks
CGI-I	This was a binary variable that represents either improvement, or no improvement. To assess improvement, we used the Clinical Global Impressions-Improvement (CGI-I) which is a global measure of improvement and functioning, and measures satisfaction with quality of close relationships. Each of the 3 items are rated on a 7-point scale from: 1 (normal) to 7 (amongst the most severely ill patients). CGI-C scores range from 7 (very much worse) to 1 (very much improved). In this study, those who scored 1, 2 or 3 were considered "improved" and those who scored 4, 5, 6 or 7 were considered "not improved."	baseline, 12 weeks
SMI	Social motivation was assessed via the Autistic Social Health Interview. The ASHI, adapted from the Social Motivation Interview (Elias & White, 2020), assesses the following dimensions of social health: person's satisfaction with their interpersonal relationships, motivation to socialize, quantity of social relationships and encounters, and willingness to persist in social interaction. During the interview, the interviewer enquires about behaviors over the prior two weeks. The total ASHI score can range from 0-24, with higher scores indicative of greater overall social health.	baseline, 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention Acceptability	An investigator developed self report 3-item scale to assess participants' feelings about whether HEARTS was informative, interesting, how likely participants would be to recommend it to other people and suggestions for how it could be improved will be used to assess this outcome. Participants will indicate their satisfaction on a scale from 1 to 10, where 10 represents highest satisfaction.	6 weeks
Content Acceptability, Week 1	This is an original measure with no scale name and with no subscales that assesses acceptability of intervention content. It is 29 items. Each item asks the participant how useful they found a piece of intervention content. Responses range from 1 to 10 with 1 representing "not at all useful" and 10 representing "very useful." The measure is scored by calculating the average across the items for a given week (Week 1, 3 items; Week 2, 6 items; Week 3, 4 items; Week 4, 6 items; Week 5, 5 items; Week 6, 5 items). The six scores representing each week are then averaged together for a total score. The total score range is 1 to 10.	weekly during the 6 weeks of the interventions
Teacher Rating of Participant Engagement and Satisfaction	Teachers of the HEARTS intervention will complete a 3-item survey to assess their rating of participant engagement and satisfaction scores (PESS). Scores can range from 0 to 3 where 0 is low and 3 is high satisfaction. Higher scores are more favorable.	weekly during the 6 weeks of the interventions

Collaborators and Investigators

• Sponsor: Boston University Charles River Campus
• Collaborators: National Institute of Mental Health (NIMH); University of Alabama at Birmingham
• Investigators: Principal Investigator: Emily F Rothman, ScD, BU Sargent College, Occupational Therapy Department

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Actual): July 31, 2024
• Study Completion (Actual): July 31, 2024

Study Registration Dates

• First Submitted: November 1, 2022
• First Submitted That Met QC Criteria: November 1, 2022
• First Posted (Actual): November 8, 2022

Study Record Updates

• Last Update Posted (Actual): June 8, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Satisfaction; Dating relationships; Friendships; Zoom sessions
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Behavior; Autism Spectrum Disorder; Personal Satisfaction
• Other Study ID Numbers: 6800E

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No