Autism Spectrum Disorder
Conditions
Keywords
Friendships, Dating relationships, Zoom sessions, Satisfaction
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.
Interventions
BEHAVIORALHEARTS 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.
BEHAVIORALOnline discussion group
A 90-minute discussion group will meet online weekly for 6 weeks to discuss friendships and healthy dating relationships for autistic adults.
Sponsors
Boston University Charles River Campus
National Institute of Mental Health (NIMH)
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hostile Automatic Thoughts (HATS) | baseline, 12 weeks | 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. |
| Rejection Sensitivity Questionnaire | baseline, 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. 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. |
| CGI-I | baseline, 12 weeks | 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." |
| SMI | baseline, 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intervention Acceptability | 6 weeks | 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. |
| Content Acceptability, Week 1 | weekly during the 6 weeks of the interventions | 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. |
| Teacher Rating of Participant Engagement and Satisfaction | weekly during the 6 weeks of the interventions | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATOREmily F Rothman, ScD
BU Sargent College, Occupational Therapy Department
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 32 years STANDARD_DEVIATION 12 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 33 Participants |
| Sex/Gender, Customized Cis-man | 20 Participants |
| Sex/Gender, Customized Cis-woman | 17 Participants |
| Sex/Gender, Customized Non-binary, transgender, or other | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 44 | 0 / 48 |
| other Total, other adverse events | 0 / 44 | 0 / 48 |
| serious Total, serious adverse events | 0 / 44 | 0 / 48 |
Outcome results
None listed