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临床试验/NCT07474207
NCT07474207尚未招募不适用

Social Identity Mapping for Adolescent Recovery

Massachusetts General Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年8月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
1
主要终点
SIM-AiR Acceptability (Treatment satisfaction)

研究概览

简要总结

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.

详细描述

  1. 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. 2. 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. 3. 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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
12 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Refusal to give informed consent, or if under 18 years old, do not have a parent willing for them to consent to participate.

研究组 & 干预措施

SIM-AiR

Experimental

As this is a single arm study, all participants will receive the SIM-AiR treatment module.

干预措施: SIM-AiR (Behavioral)

结局指标

主要结局

SIM-AiR Acceptability (Treatment satisfaction)

时间窗: 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.

SIM-AiR Acceptability (Adolescent Treatment Engagement: Counseling Rapport sub scale)

时间窗: 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.

SIM-AiR Acceptability (Acceptability of Intervention Measure)

时间窗: 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.

SIM-AiR Appropriateness (Intervention Appropriateness Measure)

时间窗: 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.

SIM-AiR Feasibility (Feasibility of Intervention Measure)

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Emily Hennessy

Principal Investigator

Massachusetts General Hospital

研究点 (1)

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