Clinical trial NCT05608083: HEARTS R34 Feasibility Study, Autistic Participants
Official title: Healthy Relationships on the Autism Spectrum: Feasibility and Target Engagement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Friendships
Dating relationships
Zoom sessions
Satisfaction
Lead sponsor: Boston University Charles River Campus
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: University of Alabama at Birmingham
First posted: 2022-11-08
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in engaging in perspective-taking related to rejection at 6 weeks
timeFrame: baseline, 6 weeks
measure: Change in engaging in perspective-taking related to rejection at 12 weeks
timeFrame: baseline, 12 weeks
measure: Change in resilience capacity given social rejection at 6 weeks
timeFrame: baseline, 6 weeks
measure: Change in resilience capacity given social rejection at 12 weeks
timeFrame: baseline, 12 weeks
measure: Change in satisfaction with close relationships at 6 weeks
timeFrame: baseline, 6 weeks
measure: Change in satisfaction with close relationships at 12 weeks
timeFrame: baseline, 12 weeks
measure: Change in motivation to interact socially at 6 weeks
timeFrame: baseline, 6 weeks
measure: Change in motivation to interact socially at 12 weeks
timeFrame: baseline, 12 weeks
Secondary outcomes:
measure: Participant satisfaction with study participation
timeFrame: 12 weeks
measure: Participant feelings of acceptability of study intervention
timeFrame: 12 weeks
measure: Participant rating of content acceptability
timeFrame: weekly during the 6 weeks of the interventions
measure: Teacher rating of participant engagement and satisfaction
timeFrame: weekly during the 6 weeks of the interventions
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University CRC
state: Massachusetts
Study officials:
affiliation: BU Sargent College, Occupational Therapy Department
name: Emily F Rothman, ScD
role: PRINCIPAL_INVESTIGATOR
References: