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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05608083
Other study ID # 6800E
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 1, 2023
Est. completion date December 2025

Study information

Verified date August 2023
Source Boston University Charles River Campus
Contact Emily F Rothman, ScD
Phone 617-353-2713
Email erothman@bu.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date December 2025
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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: - None other than does not meet inclusion

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
United States Boston University CRC Boston Massachusetts

Sponsors (3)

Lead Sponsor Collaborator
Boston University Charles River Campus National Institute of Mental Health (NIMH), University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in engaging in perspective-taking related to rejection at 6 weeks The 25-item Host Access Table (HAT) scale 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 will be used to measure this outcome. completed by participant. For each item participants will select either: often, sometimes, or never. Higher scores are associated with higher levels of perceived rejection. baseline, 6 weeks
Primary Change in engaging in perspective-taking related to rejection at 12 weeks The 25-item Host Access Table (HAT) scale 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 will be used to measure this outcome. completed by participant. For each item participants will select either: often, sometimes, or never. Higher scores are associated with higher levels of perceived rejection. baseline, 12 weeks
Primary Change in resilience capacity given social rejection at 6 weeks 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, will be used to assess this outcome. Lower scores are associated with more resilience given rejection. baseline, 6 weeks
Primary Change in resilience capacity given social rejection at 12 weeks 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, will be used to assess this outcome. Lower scores are associated with more resilience given rejection. baseline, 12 weeks
Primary Change in satisfaction with close relationships at 6 weeks The Clinical Global Impressions-Severity/Improvement (CGI-S/I), a global measure of improvement and functioning, will be used to measure 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 1 (very much improved) through to 7 (very much worse). Lower scores are favorable. baseline, 6 weeks
Primary Change in satisfaction with close relationships at 12 weeks The Clinical Global Impressions-Severity/Improvement (CGI-S/I), a global measure of improvement and functioning, will be used to measure 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 1 (very much improved) through to 7 (very much worse). Lower scores are favorable. baseline, 12 weeks
Primary Change in motivation to interact socially at 6 weeks The semi-structured social motivation interview (SMI) will be conducted by an independent evaluator to assess internal cognition related to desire, interest, and behaviors reflective of degree of motivation to interact socially. baseline, 6 weeks
Primary Change in motivation to interact socially at 12 weeks The semi-structured social motivation interview (SMI) will be conducted by an independent evaluator to assess internal cognition related to desire, interest, and behaviors reflective of degree of motivation to interact socially. baseline, 12 weeks
Secondary Participant satisfaction with study participation An investigator developed 2-item assessment will be used to assess participants' feelings about the research-related consent procedure, and experiences with the research team. Participants will indicate their satisfaction on a scale from 1 to 10, where 10 represents highest satisfaction. 12 weeks
Secondary Participant feelings of acceptability of study intervention 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. 12 weeks
Secondary Participant rating of content acceptability This outcome will be assessed by self reported ratings on each piece of intervention content after each class session, indicating how useful participants found the content. Participants will indicate their satisfaction with usefulness on a scale from 1 to 10, where 10 represents highest satisfaction. weekly during the 6 weeks of the interventions
Secondary 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
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