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

Primary Purpose

Autism Spectrum Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HEARTS classes
Online discussion group
Sponsored by
Boston University Charles River Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Autism Spectrum Disorder focused on measuring Friendships, Dating relationships, Zoom sessions, Satisfaction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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: None other than does not meet inclusion

Sites / Locations

  • Boston University CRCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HEARTS NOW

HEARTS LATER

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Participant satisfaction with study participation
An investigator developed 2-item assessment will be used to assess participants' feelings about the research-related consent procedure, and experiences with the research team. Participants will indicate their satisfaction on a scale from 1 to 10, where 10 represents highest satisfaction.
Participant feelings of acceptability of study intervention
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.
Participant rating of content acceptability
This outcome will be assessed by self reported ratings on each piece of intervention content after each class session, indicating how useful participants found the content. Participants will indicate their satisfaction with usefulness on a scale from 1 to 10, where 10 represents highest satisfaction.
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.

Full Information

First Posted
November 1, 2022
Last Updated
August 30, 2023
Sponsor
Boston University Charles River Campus
Collaborators
National Institute of Mental Health (NIMH), University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT05608083
Brief Title
HEARTS R34 Feasibility Study, Autistic Participants
Acronym
HEARTS-R34
Official Title
Healthy Relationships on the Autism Spectrum: Feasibility and Target Engagement
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston University Charles River Campus
Collaborators
National Institute of Mental Health (NIMH), University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
Friendships, Dating relationships, Zoom sessions, Satisfaction

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HEARTS NOW
Arm Type
Experimental
Arm Description
Participants in the HEARTS NOW group participants will participate in a weekly six-session online HEARTS class via Zoom about relationships.
Arm Title
HEARTS LATER
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
HEARTS classes
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Online discussion group
Intervention Description
A 90-minute discussion group will meet online weekly for 6 weeks to discuss friendships and healthy dating relationships for autistic adults.
Primary Outcome Measure Information:
Title
Change in engaging in perspective-taking related to rejection at 6 weeks
Description
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.
Time Frame
baseline, 6 weeks
Title
Change in engaging in perspective-taking related to rejection at 12 weeks
Description
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.
Time Frame
baseline, 12 weeks
Title
Change in resilience capacity given social rejection at 6 weeks
Description
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.
Time Frame
baseline, 6 weeks
Title
Change in resilience capacity given social rejection at 12 weeks
Description
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.
Time Frame
baseline, 12 weeks
Title
Change in satisfaction with close relationships at 6 weeks
Description
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.
Time Frame
baseline, 6 weeks
Title
Change in satisfaction with close relationships at 12 weeks
Description
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.
Time Frame
baseline, 12 weeks
Title
Change in motivation to interact socially at 6 weeks
Description
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.
Time Frame
baseline, 6 weeks
Title
Change in motivation to interact socially at 12 weeks
Description
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.
Time Frame
baseline, 12 weeks
Secondary Outcome Measure Information:
Title
Participant satisfaction with study participation
Description
An investigator developed 2-item assessment will be used to assess participants' feelings about the research-related consent procedure, and experiences with the research team. Participants will indicate their satisfaction on a scale from 1 to 10, where 10 represents highest satisfaction.
Time Frame
12 weeks
Title
Participant feelings of acceptability of study intervention
Description
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.
Time Frame
12 weeks
Title
Participant rating of content acceptability
Description
This outcome will be assessed by self reported ratings on each piece of intervention content after each class session, indicating how useful participants found the content. Participants will indicate their satisfaction with usefulness on a scale from 1 to 10, where 10 represents highest satisfaction.
Time Frame
weekly during the 6 weeks of the interventions
Title
Teacher rating of participant engagement and satisfaction
Description
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.
Time Frame
weekly during the 6 weeks of the interventions

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: None other than does not meet inclusion
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emily F Rothman, ScD
Phone
617-353-2713
Email
erothman@bu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily F Rothman, ScD
Organizational Affiliation
BU Sargent College, Occupational Therapy Department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston University CRC
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Rothman
Phone
617-353-2713
Email
erothman@bu.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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HEARTS R34 Feasibility Study, Autistic Participants

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