HEARTS R34 Feasibility Study, Autistic Participants

NCT05608083 | Completed

• 1 other identifier: 6800E
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Autism Spectrum Disorder

Keywords

Friendships; Dating relationships; Zoom sessions; Satisfaction

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (4)

• Participant satisfaction with study participation

  12 weeks

• Participant feelings of acceptability of study intervention

  12 weeks

• Participant rating of content acceptability

  weekly during the 6 weeks of the interventions

• Teacher rating of participant engagement and satisfaction

  weekly during the 6 weeks of the interventions

Study Arms (2)

HEARTS NOW

EXPERIMENTAL

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 LATER

ACTIVE COMPARATOR

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

Interventions

HEARTS classes BEHAVIORAL

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.

HEARTS NOW

Online discussion group BEHAVIORAL

A 90-minute discussion group will meet online weekly for 6 weeks to discuss friendships and healthy dating relationships for autistic adults.

HEARTS LATER

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston University Charles River Campus: lead
• National Institute of Mental Health (NIMH): collaborator
• University of Alabama at Birmingham: collaborator

Study Sites (1)

Boston University CRC

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Personal Satisfaction

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Behavior

Study Officials

• Emily F Rothman, ScD

  BU Sargent College, Occupational Therapy Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: November 8, 2022
• Study Start: February 1, 2023
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: December 24, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)