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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
| University of Alabama at Birmingham | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HEARTS NOW | Experimental | Participants in the HEARTS NOW group participants will participate in a weekly six-session online HEARTS class via Zoom about relationships. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Hostile Automatic Thoughts (HATS) | 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. | baseline, 12 weeks |
| Rejection Sensitivity Questionnaire | 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. | baseline, 12 weeks |
| CGI-I | 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." | baseline, 12 weeks |
| SMI | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Intervention Acceptability | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emily F Rothman, ScD | BU Sargent College, Occupational Therapy Department | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston University CRC | Boston | Massachusetts | 02215 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | HEARTS | Participants in the HEARTS group participated in a weekly six-session online HEARTS class via Zoom about relationships. 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. |
| FG001 | Active Control Condition (ACC) | Participants in the ACC condition participated in a six-week online support group via Zoom about hobbies and special interests. Online discussion group: A 90-minute discussion group met online weekly for 6 weeks to discuss hobbies and special interests. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | HEARTS | Participants in the HEARTS NOW group participants will participate in a weekly six-session online HEARTS class via Zoom about relationships. |
| BG001 | Active Control Condition |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hostile Automatic Thoughts (HATS) | 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. | Posted | Mean | Standard Deviation | score on a scale | baseline, 12 weeks |
|
From enrollment until the end of follow-up, up to 12 weeks.
Did not differ
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HEARTS | Participants in the HEARTS group participated in 6 weekly online sessions about healthy relationships. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Emily F. Rothman | Boston University Charles River Campus | 617-353-7518 | erothman@bu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 16, 2026 | Apr 16, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 19, 2026 | Mar 20, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D010549 | Personal Satisfaction |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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| 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. |
|
| baseline, 12 weeks |
| 6 weeks |
| Content Acceptability, Week 1 | 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. | weekly during the 6 weeks of the interventions |
| 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 |
Participants in the active control condition participated in a six-week online support group via Zoom about hobbies and interests.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Sex/Gender | Count of Participants | Participants |
|
| Race (NIH/OMB) | Race | Count of Participants | Participants |
|
| OG001 |
| Active Control Condition |
Participants in the ACC group participated in a six-week online support group via Zoom about hobbies and interests. |
|
|
|
| Primary | Rejection Sensitivity Questionnaire | 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. | Posted | Mean | Standard Deviation | score on a scale | baseline, 12 weeks |
|
|
|
|
| Primary | CGI-I | 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." | Posted | Number | percentage of those who improved | baseline, 12 weeks |
|
|
|
|
| Primary | SMI | 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. | Posted | Mean | Standard Deviation | score on a scale | baseline, 12 weeks |
|
|
|
|
| Secondary | Intervention Acceptability | 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. | The measures of acceptability of research procedures were only collected from those in the HEARTS group. These data were not collected from those in the active control condition. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks |
|
|
|
| Secondary | Content Acceptability, Week 1 | 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. | Of the 44 individuals allocated to the HEARTS condition, n=39 participated in ≥4 classes (per protocol analysis) and 1 participant did not contribute acceptability or satisfaction data. | Posted | Mean | Standard Deviation | Score on a scale | 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. | Not Posted | Dec 2026 | weekly during the 6 weeks of the interventions | Participants |
| 0 |
| 44 |
| 0 |
| 44 |
| 0 |
| 44 |
| EG001 | Active Control Condition | Participants in the active control condition group participated in a six-week online group about hobbies and interests. | 0 | 48 | 0 | 48 | 0 | 48 |
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| Title | Measurements |
|---|---|
|