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| ID | Type | Description | Link |
|---|---|---|---|
| 1R61DA064788-01 | U.S. NIH Grant/Contract | View source |
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The goal of this clinical trial is to learn if a 1-on-1 support program is easy to complete and acceptable for people supporting loved ones who have recently received treatment for substance use. The main questions it aims to answer are:
How many people complete the program? How satisfied are people with the program?
Participants will:
Complete weekly telehealth sessions for 12 weeks Complete surveys/interviews at the beginning, in the middle (~week 6), at the end of the program (~week 12), and 12-weeks after the end of the program Complete a focus group or interview
The program aims to improve support person well-being, social recovery capital, and their loved one's substance use outcomes. Information from support persons and loved ones with a substance use disorder will be collected for program feedback and hypothesis generating purposes. Target enrollment for the clinical trial is 15 pairs of support persons and their loved one. We will plan to recruit 18 pairs of participants in case some people may not complete the study (~15%). Total planned enrollment of support persons (n=18) and their loved ones (n=18) is N=36.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Invitation to Change (ITC) | Experimental | 12 weekly individual sessions of 60-minute ITC coaching |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ITC | Behavioral | ITC is a behavioral intervention delivered via telehealth. The coaching session topics include skills to help with understanding, awareness, and action. The intervention is designed for support persons of individuals living with a substance use disorder. |
| Measure | Description | Time Frame |
|---|---|---|
| Program Completion | Proportion of participants completing 12-session program | From enrollment to the end of the program (12 weeks). |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Session Satisfaction | Participants will report weekly satisfaction (helpfulness) ratings following each session on the Session Survey. Ratings will range from 1 (poor) to 5 (excellent). | From enrollment to the end of the program (12 weeks). |
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Inclusion Criteria:
Inclusion Criteria for Support Persons:
Inclusion Criteria for Loved Ones:
Exclusion Criteria:
Exclusion Criteria for Support Persons:
Exclusion Criteria for Loved Ones: N/A
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julie M McCarthy, PhD | Contact | 16178553521 | jmccarthy@mclean.harvard.edu | |
| Roger D Weiss, PhD | Contact | 617-855-2242 | rweiss@mclean.harvard.edu |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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