Radovic Ana, Li Yaming, Landsittel Doug, Odenthal Kayla R, Stein Bradley D, Miller Elizabeth
Division of Adolescent and Young Adult Medicine, University of Pittsburgh Medical Center Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, Pittsburgh, PA, United States.
Department of Biomedical Informatics, University of Pittsburgh, Pittsburgh, PA, United States.
JMIR Ment Health. 2022 Oct 7;9(10):e35313. doi: 10.2196/35313.
Adolescents with depression or anxiety initiate mental health treatment in low numbers. Supporting Our Valued Adolescents (SOVA) is a peer support website intervention for adolescents seen in primary care settings and their parents with the goal of increasing treatment uptake through changing negative health beliefs, enhancing knowledge, offering peer emotional support, and increasing parent-adolescent communication about mental health.
This pilot study aimed to refine recruitment and retention strategies, refine document intervention fidelity, and explore changes in study outcomes (the primary outcome being treatment uptake).
We conducted a 2-group, single-blind, pilot randomized controlled trial in a single adolescent medicine clinic. Participants were aged 12 to 19 years with clinician-identified symptoms of depression or anxiety for which a health care provider recommended treatment. The patient and parent, if interested, were randomized to receive the SOVA websites and enhanced usual care (EUC) compared with EUC alone. Baseline, 6-week, and 3-month measures were collected using a web-based self-report survey and blinded electronic health record review. The main pilot outcomes assessed were the feasibility of recruitment and retention strategies. Implementation outcomes, intervention fidelity, missingness, and adequacy of safety protocols were documented. Descriptive statistics were used to summarize mental health service use and target measures with 2-sample t tests to compare differences between arms.
Less than half of the adolescents who were offered patient education material (195/461, 42.2%) were referred by their clinician to the study. Of 146 adolescents meeting the inclusion criteria, 38 completed the baseline survey, qualifying them for randomization, and 25 (66%, 95% CI 51%-81%) completed the 6-week measures. There was limited engagement in the treatment arm, with 45% (5/11) of adolescents who completed 6-week measures reporting accessing SOVA, and most of those who did not access cited forgetting as the reason. Changes were found in target factors at 6 weeks but not in per-protocol analyses. At 12 weeks, 83% (15/18) of adolescents randomized to SOVA received mental health treatment as compared with 50% (10/20) of adolescents randomized to EUC (P=.03).
In this pilot trial of a peer support website intervention for adolescents with depression or anxiety, we found lower-than-expected study enrollment after recruitment. Although generalizability may be enhanced by not requiring parental permission for adolescent participation in the trials of mental health interventions, this may limit study recruitment and retention. We found that implementing education introducing the study into provider workflow was feasible and acceptable, resulting in almost 500 study referrals. Finally, although not the primary outcome, we found a signal for greater uptake of mental health treatment in the arm using the SOVA intervention than in the usual care arm.
ClinicalTrials.gov NCT03318666; https://clinicaltrials.gov/ct2/show/NCT03318666.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/12117.
患有抑郁症或焦虑症的青少年很少开始接受心理健康治疗。支持我们宝贵的青少年（SOVA）是一个针对在初级保健机构就诊的青少年及其父母的同伴支持网站干预项目，其目标是通过改变负面健康观念、增强知识、提供同伴情感支持以及增加父母与青少年之间关于心理健康的沟通来提高治疗接受率。
这项试点研究旨在完善招募和保留策略，提高文件干预保真度，并探索研究结果的变化（主要结果是治疗接受率）。
我们在一家青少年医学诊所进行了一项两组、单盲、试点随机对照试验。参与者年龄在12至19岁之间，有临床医生确定的抑郁症或焦虑症症状，且医疗保健提供者建议进行治疗。如果患者和家长感兴趣，他们被随机分配接受SOVA网站和强化常规护理（EUC），与仅接受EUC进行比较。使用基于网络的自我报告调查和盲态电子健康记录审查收集基线、6周和3个月的测量数据。评估的主要试点结果是招募和保留策略的可行性。记录了实施结果、干预保真度、缺失情况和安全协议的充分性。使用描述性统计来总结心理健康服务的使用情况和目标测量数据，并使用双样本t检验来比较两组之间的差异。
在获得患者教育材料的青少年中，不到一半（195/461，42.2%）被其临床医生转介到该研究中。在146名符合纳入标准的青少年中，38人完成了基线调查，有资格进行随机分组，25人（66%，95%CI 51%-81%）完成了6周的测量。治疗组的参与度有限，完成6周测量的青少年中有45%（5/11）报告访问了SOVA，大多数未访问的人将忘记作为原因。在6周时发现目标因素有变化，但在符合方案分析中未发现。在12周时，随机分配到SOVA组的青少年中有83%（15/18）接受了心理健康治疗，而随机分配到EUC组的青少年中有50%（10/20）接受了治疗（P = 0.03）。
在这项针对患有抑郁症或焦虑症青少年的同伴支持网站干预的试点试验中，我们发现招募后研究入组人数低于预期。虽然在青少年参与心理健康干预试验时不要求父母同意可能会提高普遍性，但这可能会限制研究的招募和保留。我们发现将研究介绍纳入提供者工作流程的教育实施是可行且可接受的，从而产生了近500个研究转介。最后，虽然不是主要结果，但我们发现使用SOVA干预的组比常规护理组有更多接受心理健康治疗的迹象。
ClinicalTrials.gov NCT03318666；https://clinicaltrials.gov/ct2/show/NCT03318666。
国际注册报告标识符（IRRID）：RR2-10.2196/12117。
