Hogue Aaron, Bobek Molly, Porter Nicole P, MacLean Alexandra, Henderson Craig E, Jensen-Doss Amanda, Diamond Gary M, Southam-Gerow Michael A, Ehrenreich-May Jill
Family and Adolescent Clinical Technology & Science, Partnership to End Addiction, New York, NY, United States.
Department of Psychology, Sam Houston State University, Huntsville, TX, United States.
JMIR Res Protoc. 2024 Sep 16;13:e64332. doi: 10.2196/64332.
Internalizing disorders (IDs), primarily depression and anxiety, are highly prevalent among adolescents receiving community-based treatment for substance use disorders (SUDs). For such clients, interventions that do not holistically address both SUDs and IDs are less effective.
This pilot treatment development study aims to develop and test a modular treatment protocol for addressing cooccurring IDs among adolescents (aged 13 to 18 years) enrolled in routine care for substance use problems: Family Support Protocol for Adolescent Internalizing Disorders (Fam-AID). As an adjunctive protocol, Fam-AID will not require clinicians to markedly alter existing base practices for SUD. It will be anchored by 3 evidence-based foundations for treating cooccurring adolescent IDs: family engagement techniques, transdiagnostic individual cognitive behavioral therapy techniques, and family psychoeducation and safety planning.
This quasi-experimental study will proceed in 2 stages. The pilot stage will use rapid-cycle prototyping methods in collaboration with end-user stakeholders to draft protocol delivery and fidelity guidelines adapted from existing resources, solicit provider and client input on protocol content and delivery via cognitive interviewing, and pilot prototype components on 4 to 6 cases. The second stage will be an interrupted time series study for 60 comorbid SUD+ID cases across 2 sites serving diverse adolescents: 30 will receive treatment as usual (TAU); following clinician training in the protocol, 30 new cases will receive TAU enhanced by Fam-AID. For aim 1, the focus is on evaluating the acceptability of the Fam-AID protocol through therapist and client interviews as well as assessing fidelity benchmarks using therapist- and observer-reported protocol fidelity data. For aim 2, the plan is to compare the effects of TAU only cases versus TAU+Fam-AID cases on family treatment attendance and on adolescent ID and substance use symptoms, with measurements taken at baseline and at 3-month and 6-month follow-ups.
Study recruitment will begin in April 2025.
We anticipate that Fam-AID will contain 5 treatment modules that can be delivered in any sequence to meet client needs: family engagement of primary supports in treatment planning and services; relational reframing of family constraints, resiliencies, and social capital connected to the adolescent's ID symptoms; functional analysis of the adolescent's ID symptoms and related behaviors; cognitive behavioral therapy to address the adolescent's ID symptoms and functional needs, featuring 3 core techniques (emotion acceptance, emotional exposure, and behavioral activation) to address negative affect and emotional dysregulation; and family psychoeducation and safety planning focused on education about comorbid SUD+ID and prevention of adolescent self-harm. If the abovementioned modules are found to be feasible and effective, Fam-AID will offer a set of pragmatic interventions to SUD clinicians for treating cooccurring IDs in adolescent clients.
ClinicalTrials.gov NCT06413979; https://www.clinicaltrials.gov/study/NCT06413979.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/64332.
内化性障碍（IDs），主要是抑郁症和焦虑症，在接受社区药物使用障碍（SUDs）治疗的青少年中非常普遍。对于这类客户，不能全面解决药物使用障碍和内化性障碍的干预措施效果较差。
这项初步治疗开发研究旨在为参加药物使用问题常规护理的青少年（13至18岁）制定并测试一种模块化治疗方案，以解决同时出现的内化性障碍：青少年内化性障碍家庭支持方案（Fam-AID）。作为一种辅助方案，Fam-AID不需要临床医生显著改变现有的药物使用障碍基础治疗方法。它将以治疗青少年同时出现的内化性障碍的3个循证基础为依托：家庭参与技巧、跨诊断个体认知行为治疗技巧以及家庭心理教育和安全规划。
这项准实验研究将分两个阶段进行。试点阶段将与最终用户利益相关者合作，采用快速循环原型制作方法，根据现有资源起草方案实施和保真度指南，通过认知访谈征求提供者和客户对方案内容和实施的意见，并对4至6个案例进行试点原型组件测试。第二阶段将是一项中断时间序列研究，针对2个为不同青少年服务的地点的60例共病药物使用障碍+内化性障碍病例：30例将接受常规治疗（TAU）；在临床医生接受该方案培训后，30例新病例将接受TAU并辅以Fam-AID。对于目标1，重点是通过治疗师和客户访谈评估Fam-AID方案的可接受性，并使用治疗师和观察者报告的方案保真度数据评估保真度基准。对于目标2，计划比较仅接受TAU治疗的病例与接受TAU+Fam-AID治疗的病例在家庭治疗出勤率、青少年内化性障碍和药物使用症状方面的效果，在基线、3个月和6个月随访时进行测量。
研究招募将于2025年4月开始。
我们预计Fam-AID将包含5个治疗模块，可按任何顺序提供以满足客户需求：在治疗计划和服务中让主要支持人员参与家庭；对与青少年内化性障碍症状相关的家庭限制、恢复力和社会资本进行关系重构；对青少年内化性障碍症状和相关行为进行功能分析；采用认知行为疗法解决青少年内化性障碍症状和功能需求，包括3种核心技术（情绪接纳、情绪暴露和行为激活）以解决负面影响和情绪失调；以及专注于共病药物使用障碍+内化性障碍教育和预防青少年自我伤害的家庭心理教育和安全规划。如果上述模块被证明是可行和有效的，Fam-AID将为药物使用障碍临床医生提供一套实用的干预措施，用于治疗青少年客户中同时出现的内化性障碍。
ClinicalTrials.gov NCT06413979；https://www.clinicaltrials.gov/study/NCT06413979。
国际注册报告识别码（IRRID）：PRR1-10.2196/64332。
