Evaluating an Online, Single-Session Intervention Targeting Self-Injurious Behavior in Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 565
- 试验地点
- 1
- 主要终点
- Nonsuicidal Self-injury Frequency in the Past 3 Months
研究概览
简要总结
Participants (aged 13-16) will be randomized to: (1) an online, active control group program encouraging feelings disclosure (i.e. supportive therapy single session intervention [SSI]), or (2) an online program targeting nonsuicidal self-injury (NSSI; i.e. Project "SAVE"-Stop Adolescent Violence Everywhere-SSI). Investigators will test whether SAVE results in significantly greater:
- Reductions in NSSI 3 months post-treatment [primary outcome]
- Reductions in self-reported likelihood of future NSSI immediately post-treatment [secondary outcome]
- Reduction in suicide ideation frequency 3 months post-treatment [secondary outcome]
详细描述
Most mental health problems emerge by age 14, often leading to chronic impairments and adverse impacts for individuals, families, and societies. Similarly, suicidal thoughts and behaviors are relatively rare during childhood but increase significantly during the transition to adolescence. Self-injurious thoughts and behaviors (SITBs), which include suicidal thoughts and behaviors and nonsuicidal self-injury (NSSI; intentional self-harm enacted without suicidal intent), are among the best predictors of future suicidal thoughts and attempts in the current state of literature on the topic. There is also significant escalation from suicidal thoughts to suicidal behaviors during this developmental period. Most youth who transition from suicidal thoughts to suicidal behaviors will do so within 1-2 years after the onset of suicide ideation, which tends to begin in adolescents. Taken together, adolescence is a key developmental period for effective depression and suicide intervention and prevention. The goal of these studies is to test Single Session Interventions (SSIs) (defined below) that are designed to boost coping and resilience in adolescents. The investigators hope that this research will be valuable in ensuring that these SSIs are accessible to more adolescents.
Despite significant strides in the development of psychosocial treatments for youth mental health problems, up to 80% of youth in the United States with mental health needs receive no services at all. Even when services are accessed, the definition of "treatment" is incredibly broad, with evidence-based interventions being the exception, not the rule. More typically, "treatment" may involve a single, unstructured contact with a medical doctor, counselor, emergency hotline, religious leader, or other health professional (e.g., occupational therapist), the benefits of which are unknown.
This reality poses a critical challenge to the field of clinical intervention science-one that has been articulated many times before. Eight years ago, Kazdin and Blase (2011) called for a "rebooting" of psychotherapy research and practice, stating that "mental health professionals are not likely to reduce the prevalence, incidence, and burden of mental illness without a major shift in intervention research and clinical practice" via a portfolio of novel approaches to service delivery. Yet again, Kazdin (2019) asked us to reconsider how psychotherapy can and should be delivered: He argues that without removing requirements of a face-to-face format, an 'expert' with years of training, and a physical office, the need-to-access gap will likely stay stagnant. Indeed, Kazdin (2019) asserts the need to think about therapeutic action through an entirely new lens, asserting that "interventions may or may not rely on the psychological treatments that continue to dominate research."
Any action-focused path to reducing the need-to-access gap will require moving beyond the dominant settings, formats, and systems that have constrained intervention delivery to date. Indeed, as Chorpita (2019) asserts, "it may well be time we move past thinking about 'treatments' as our only form of solutions" (p. 475), with "treatments" referencing the dominant design of current psychosocial therapies: weekly, clinician-delivered interventions in brick-and mortar clinical settings, which are too often inaccessible to those they are designed to serve.
Brief, online interventions:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Random assignment to condition will be conducted in a triple-masked manner. Participants will be masked to whether they received active treatment and investigators will be masked to which condition the participant is randomized to-as the randomization occurs automatically within the Qualtrics survey. Additionally, as the primary and secondary outcomes are self-report measures, we will not be utilizing an outcomes assessor (e.g. a clinical interviewer).
入排标准
- 年龄范围
- 13 Years 至 16 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must be 13 - 16 years old at the time of the baseline survey
- •Must report comfort reading and writing in English
- •Must endorse no learning disability, visual impairment, or other difficulty that makes it difficult to answer questions on a computer
- •Must have access to a laptop or smartphone with internet access
- •Must endorse purposefully hurting self without wanting to die within the past month
- •Must endorse either "I do not like myself" or "I hate myself" on CDI-II item 7 in a screener survey
排除标准
- •Type 1 exclusions are exclusions that can be automated and do not require consensus among investigators. A research team member who will not be involved with conducting the primary study analyses will use type 1 exclusions to determine when participant recruitment is complete. Recruitment for the present study will end once 500 participants have been randomized who pass all type 1 exclusions tests (i.e. are still eligible for inclusion after excluding for type 1 criteria; see our section on sample size for more details).
- •Type 1 exclusions include:
- •Not meeting inclusion criteria
- •Participants who exit the study prior to condition randomization for our listed analyses (note: the present study will use an intention-to-treat approach, where every participant who was randomized to a study condition-and who is not excluded for one of the specific reasons outlined in this section-will be included our our analyses)
- •Type 2 Exclusions
- •Type 2 exclusions are exclusions that cannot be automated and require consensus among investigators. Participants excluded for type 2 reasons will be subtracted from the N = 500 total individuals who were randomized and met criteria for inclusion following type 1 exclusions.
- •Here, we will exclude the following participants based on failure to meet the following quality check criteria:
- •Participants who respond with either copy/pasted responses from text earlier in the intervention (e.g. copy and pasting only text from a previous testimonial slide) to any of free response questions Participants demonstrating an obvious lack of English fluency in open response questions; these participants will be identified by consensus from all study team members Participants responding with random text in open response questions; these participants will be identified by consensus from all study team members Duplicate responses from the same individual in baseline or follow-up surveys (i.e. more than one response with an identical IP address). Where duplicate responses for the same individual are present in the same survey (e.g. more than 1 response for a single individual at follow-up), we will exclude the response that is less complete, retaining the more complete of the two responses. If both responses are 100% complete, we will retain the first of the two responses for that survey. Notably, if an individual completes the baseline survey more than once-and happens to be randomized to both conditions-we will exclude this individual's responses from our analysis altogether.
- •We will also exclude for primary analyses (but may run sensitivity analyses including them) any participants who provide responses of 3 words or fewer to writing prompts that ask for at least 2 sentences or more.
- •These exclusions are based on previous single session intervention research conducted online
- •(for one example, see Schleider & Weisz, 2018: https://doi.org/10.1080/15374416.2017.1405353)
研究组 & 干预措施
Project SAVE ("Stop Adolescent Violence Everywhere") SSI
SAVE is a ~30-minute, self-administered, web-based program that uses components of cognitive behavior therapy and dialectical behavior therapy designed to decrease self-injurious behaviors in youth. The Project SAVE SSI has 4 general content sections: (1) explaining the science behind how changing your actions (i.e. decreasing self-injurious behaviors) can positively impact your emotions over time; (2) providing scientific evidence and testimonials from other teens that have successfully decreased their self-injurious behaviors and noticed positive change as a result; (3) evidence-based tips for overcoming common obstacles to decreasing self-injurious behaviors in day to day life; and (4) offering an opportunity for youth to share their own thoughts and advice on what they have learned with other teenagers who are facing similar challenges.
干预措施: Project SAVE ("Stop Adolescent Violence Everywhere") SSI (Other)
Supportive Therapy ("Share Your Feelings") SSI
Supportive Therapy SSI (Schleider & Weisz, 2018): ~30-minute, self-administered, web-based program that uses components of supportive therapy to encourage feelings sharing. The supportive therapy SSI encourages participants in the control group to identify and express their feelings by (1) explaining why sharing feelings is natural, important, and helpful and (2) including testimonials from teens who have shared their feelings with close others.
干预措施: Active Comparator: Supportive Therapy ("Share Your Feelings") SSI (Other)
结局指标
主要结局
Nonsuicidal Self-injury Frequency in the Past 3 Months
时间窗: Baseline & 3 months post-intervention
Our primary outcome variable will compare past 3-month Nonsuicidal self-injury (NSSI) frequency at 3-month follow-up-for participants assigned to the Project SAVE single session intervention versus supportive therapy single session intervention (i.e. control condition). Participants will indicate "how many times they have purposely hurt themselves without wanting to die" in the past 3 months in an open-response text box. Notably, in the present study's survey flow, this question is displayed following display logic-such that participants endorsing zero nonsuicidal self-injury in the past 3-months (via a previous question) skip to the end of the question block and are not prompted to answer our main frequency outcome question. For these individuals, we will impute a past 3-month frequency value equal to 0 (as they have endorsed zero nonsuicidal self-injury in the previous 3 months in the earlier question).
次要结局
- Likelihood of Future NSSI (Mean Difference From Pre- to Post-intervention).(baseline & immediately post-intervention)
- Suicide Ideation(Baseline & 3 months post-intervention)
研究者
Kathryn Fox
Assistant Professor
University of Denver
