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

Boston University Charles River Campus

Status: Completed

Conditions: Autism Spectrum Disorder

Treatments: Behavioral: HEARTS classes; Behavioral: Online discussion group

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05608083

6800E

Details and patient eligibility

About

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.

Enrollment: 92 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

92 participants in 2 patient groups

HEARTS NOW

Experimental group

Description:

Participants in the HEARTS NOW group participants will participate in a weekly six-session online HEARTS class via Zoom about relationships.

Treatment:

Behavioral: HEARTS classes

HEARTS LATER

Active Comparator group

Description:

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.

Treatment:

Behavioral: Online discussion group