- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07474207
Social Identity Mapping for Adolescent Recovery (SIMAiR)
The goal of this clinical trial is to address the gap between clinical treatment and adolescents' lived social environments by developing and testing a novel, interactive intervention-SIM-AiR-that directly targets social risk and protective factors. By helping youth visually and cognitively process their social identities and networks, SIM-AiR seeks to support more enduring recovery outcomes in adolescents (12-19 years old) with alcohol use disorder (AUD). The specific aims of this study protocol are to pilot the SIM-AiR intervention module and collect participant acceptability feedback and preliminary outcomes. The main questions it aims to answer are:
What is the acceptability of the SIM-AiR treatment module from the perspective of participants? Do participants' acceptability ratings of the SIM-AiR treatment module vary by personal and/or social network characteristics?
Clinicians will implement the SIM-AiR with an adolescent client. Clinicians will provide feedback to the study team on their experience to support future implementation. Participants will complete the SIM-AiR module during a treatment session with their clinician and participate in data collection with study staff (e.g., surveys, interviews) following the treatment session.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Specific Aims and Objectives
The specific aims of this study protocol are to pilot the SIM-AiR intervention module with 60 adolescents (12-19 years old) with alcohol use disorder (AUD) and collect patient acceptability feedback and preliminary outcomes. 60 adolescents receiving outpatient AUD treatment will be recruited to receive the SIM-AiR module and to participate in study visit to collect acceptability information.
General Description of Study Design
This is Aim 2 of the R34 grant proposal, which is an intervention development grant. Aim 1 of this grant is pilot work directly with clinicians to finalize the treatment module. The SIM-AiR module will be incorporated as a single session for patients attending adolescent outpatient treatment program. In line with the aims of this as a pilot project, investigators will recruit clinicians to pilot the SIM-AiR and then our study team will conduct a single study visit with the clinician to get their feedback and with the adolescent to collect their acceptability feedback and other characteristics to consider necessary steps adaptation for implementation in a future larger clinical trial. As a pilot study, our focus will be on recruiting adolescents already seeking AUD treatment.
Study Procedures
After the adolescent participant has consented, the participant will be able to schedule their intervention session and study visit. The clinician will deliver the SIM-AiR in an individual treatment session with an adolescent client that will occur sometime after their initial treatment session. The session will be audio-recorded for fidelity. After each session, clinicians will be asked to complete an online survey about their immediate impressions of implementing the SIM-AiR with their client. The participant will also complete an interview after the first implementation of SIM-AiR to get immediate feedback on any areas that need to be adapted for future implementation. As clinicians conduct more SIM-AiR sessions study staff will conduct interviews, as necessary, to collect any new feedback on the procedure and materials.
The adolescent participant will also be scheduled to participate in data collection following the treatment session with a member of the study team. A subset of adolescents will be selected for the interview. For those clients, the survey will be followed by the brief, audio-recorded interview with a member of the study team.
Description of intervention: The clinician would engage the adolescent participant in the activity of social identity mapping (SIM) and use that to have a discussion, using motivational interviewing principles, about their social networks and social influences (supports, barriers) for treatment and recovery. The SIM process involves posing a series of questions to produce a visual map of the individual within their social network using paper, markers, and stickers. The SIMs capture the following data: size of social network via the number of social groups represented, each group's importance to the individual, number of days/month spent with each group, one's level of identification with each group, level of conflict between self and each group and between each group with each other, level of commonality between self and each group and between each group with each other, alcohol and other drug use among group members, type of group. The clinician would follow the SIM process with a motivational-interviewing styled discussion to elicit reflections from the participant and specific action steps the participant can take in their recovery process when with members of their social network.
Description of data variables to be collected: Adolescents will be asked to complete an electronic survey to capture psychosocial characteristics. Clinicians will also complete a brief survey and an interview.
- Statistical Analysis
There is no plan to conduct interim or futility analyses given the pilot nature of the clinical trial. Alpha levels will be adjusted as appropriate depending on whether preliminary analyses or reviews of collected data are done, as well as when conducting any confirmatory a priori-specified analyses. The analysis will examine the acceptability of the SIM-AiR from the adolescent perspective by their Treatment Satisfaction score. In addition, distributions, descriptive statistics, and correlations for all survey measures will be examined including components from the SIM (i.e., number of groups, importance of groups, and sober versus substance-using groups; degree of importance and identification with low- and high-risk groups) to examine whether a participant's acceptability rating of the SIM-AiR varies by personal and/or social network characteristics. The analysis will take descriptive qualitative and constant comparative approaches to examine major themes related to the acceptability of the SIM-AiR module.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jaden Femrite
- Phone Number: 978-473-0222
- Email: jfemrite@mgh.harvard.edu
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Recovery Research Institute; National Center on Youth Prevention, Treatment, & Recovery; Harvard Medical School
-
Contact:
- Emily A Hennessy, PhD
- Phone Number: 9784730222
- Email: ehennessy@mgh.harvard.edu
-
Principal Investigator:
- Emily A Hennessy, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Eligible participants are adolescents (ages 12-19) enrolled as outpatient clients at an addiction treatment facility.
- Meet criteria for alcohol use disorder (mild to severe) as per the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V).
- Be able to speak, read, and understand English.
Exclusion Criteria:
- Refusal to give informed consent, or if under 18 years old, do not have a parent willing for them to consent to participate.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: SIM-AiR
As this is a single arm study, all participants will receive the SIM-AiR treatment module.
|
The clinician would engage the adolescent participant in the activity of social identity mapping (SIM) and use that to have a discussion, using motivational interviewing principles, about their social networks and social influences (supports, barriers) to treatment and recovery.
The SIM process involves posing a series of questions to produce a visual map of the individual within their social network using paper, markers, and stickers.
As this is a pilot study, this will be done once.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
SIM-AiR Acceptability (Treatment satisfaction)
Time Frame: Baseline
|
The acceptability of the SIM-AiR module from adolescents' perspectives will be assessed using the validated Treatment Satisfaction scale.
Participants will answer 5 questions on a likert scale of (1) 'Strongly disagree' to (5) 'Strongly agree'.
Scores range from 5-25, with higher scores indicating a greater satisfaction with the SIM-AiR module.
|
Baseline
|
|
SIM-AiR Acceptability (Adolescent Treatment Engagement: Counseling Rapport sub scale)
Time Frame: Baseline
|
The acceptability of the SIM-AiR module from adolescents' perspectives will be assessed using the validated Counseling Rapport sub scale of the TCU Adolescent Engagement Form.
Participants will answer 11 questions on a likert scale of (1) 'Strongly disagree' to (5) 'Strongly agree'.
Scores range from 10-50, with higher scores indicating a greater rapport with the treatment counselor.
|
Baseline
|
|
SIM-AiR Acceptability (Acceptability of Intervention Measure)
Time Frame: Baseline
|
The acceptability of the SIM-AiR module from clinicians' perspectives will be assessed using the validated Acceptability of Intervention Measure (AIM).
Clinicians will answer 4 questions on a likert scale of (1) 'Completely disagree' to (5) 'Completely agree'.
Scores range from 4-20, with higher scores indicating a greater perceived acceptability of the SIM-AiR as a treatment module.
|
Baseline
|
|
SIM-AiR Appropriateness (Intervention Appropriateness Measure)
Time Frame: Baseline
|
The appropriateness of the SIM-AiR module from clinicians' perspectives will be assessed using the validated Intervention Appropriateness Measure (IAM).
Clinicians will answer 4 questions on a likert scale of (1) 'Completely disagree' to (5) 'Completely agree'.
Scores range from 4-20, with higher scores indicating a greater perceived appropriateness of the SIM-AiR as a treatment module.
|
Baseline
|
|
SIM-AiR Feasibility (Feasibility of Intervention Measure)
Time Frame: Baseline
|
The feasibility of the SIM-AiR module from clinicians' perspectives will be assessed using the validated Feasibility of Intervention Measure (FIM).
Clinicians will answer 4 questions on a likert scale of (1) 'Completely disagree' to (5) 'Completely agree'.
Scores range from 4-20, with higher scores indicating a greater perceived feasibility of the SIM-AiR as a treatment module.
|
Baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Emily A Hennessy, PhD, Recovery Research Institute; National Center on Youth Prevention, Treatment, & Recovery; Harvard Medical School
Publications and helpful links
General Publications
- Jurinsky J, Cowie K, Blyth S, Hennessy EA. "A lot better than it used to be": A qualitative study of adolescents' dynamic social recovery capital. Addict Res Theory. 2023;31(2):77-83. doi: 10.1080/16066359.2022.2114076. Epub 2022 Aug 29.
- Hennessy EA, Jurinsky J, Cowie K, Pietrzak AZ, Blyth S, Krasnoff P, Best D, Litt M, Johnson BT, Kelly JF. Visualizing the Influence of Social Networks on Recovery: A Mixed-Methods Social Identity Mapping Study with Recovering Adolescents. Subst Use Misuse. 2024;59(9):1405-1415. doi: 10.1080/10826084.2024.2352618. Epub 2024 May 13.
- Blyth SH, Pietrzak A, Rodriguez WA, Litt MD, Kelly JF, Hennessy EA. A Qualitative Examination of Addiction Disclosure and Stigma among Recovering Adolescents. Addict Res Theory. 2025;33(4):286-293. doi: 10.1080/16066359.2024.2431598. Epub 2024 Nov 28.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025P001514
- 1R34AA032288-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Alcohol Use Disorder (AUD)
-
University of Wisconsin, MadisonNational Institute on Alcohol Abuse and Alcoholism (NIAAA)Not yet recruitingAlcohol Use Disorder | Alcohol Use Disorder (AUD)United States
-
Washington State UniversityRecruitingNicotine Use Disorder | Alcohol Use Disorder (AUD)United States
-
University of BernRecruitingAlcohol Use Disorder (AUD) | Substance Use Disorder (SUD) | Cocaine Use Disorder (CUD)Switzerland
-
Brigham and Women's HospitalRecruitingAlcohol Use Disorder (AUD)United States
-
University of PittsburghFogarty International Center of the National Institute of HealthNot yet recruiting
-
VA Office of Research and DevelopmentRecruitingAlcohol Use Disorder (AUD)United States
-
Nicholas Balderston, PhDTerminated
-
Virginia Polytechnic Institute and State UniversityFralin Biomedical Research InstituteCompleted
-
National Institute on Alcohol Abuse and Alcoholism...RecruitingAlcohol Use Disorder (AUD)United States
-
University of Southern DenmarkNot yet recruitingAlcohol Use Disorder (AUD)
Clinical Trials on SIM-AiR
-
University of AarhusCentral Denmark RegionWithdrawnAll Acutely Ill or Injured Patients Receiving Care by Ambulance PersonnelDenmark
-
University of LahoreEnrolling by invitationSacroiliac Joint DysfunctionPakistan
-
HealthPartners InstituteNational Heart, Lung, and Blood Institute (NHLBI); University of Minnesota; Kaiser...Completed
-
Gilead SciencesTerminatedLiver Fibrosis Due to NASHUnited States, Canada, France, Italy, Germany, Puerto Rico, Spain, United Kingdom
-
Gilead SciencesTerminatedLiver Fibrosis Due to NASHUnited States, Spain, France, Canada, Germany, Italy, Puerto Rico, United Kingdom, Belgium
-
New York UniversityRecruitingSickle Cell DiseaseNigeria
-
Duke UniversityRecruitingSimulation Training | Point-of-care Ultrasound | Medical Education in Emergency UltrasoundUnited States
-
Gilead SciencesCompletedNon-Alcoholic Steatohepatitis (NASH)United States, Canada
-
Universidade Federal FluminenseUnknownBone Regeneration | Alveolar Socket PreservationBrazil
-
IRCCS San RaffaeleActive, not recruitingMild Cognitive Impairment (MCI) | Neurodegenerative Disease | Neurodegenerative Dementia | AMCI - Amnestic Mild Cognitive ImpairmentItaly