Nonsuicidal Self Injury Clinical Trial
— Project SAVEOfficial title:
Evaluating an Online, Single-Session Intervention Targeting Self-Injurious Behavior in Adolescents
NCT number | NCT04498143 |
Other study ID # | 1505797-4 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | August 18, 2020 |
Est. completion date | May 2021 |
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:
1. Reductions in NSSI 3 months post-treatment [primary outcome]
2. Reductions in self-reported likelihood of future NSSI immediately post-treatment
[secondary outcome]
3. Reduction in suicide ideation frequency 3 months post-treatment [secondary outcome]
Status | Recruiting |
Enrollment | 500 |
Est. completion date | May 2021 |
Est. primary completion date | November 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 13 Years to 16 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: 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) |
Country | Name | City | State |
---|---|---|---|
United States | University of Denver (though recruitment takes place online) | Denver | Colorado |
Lead Sponsor | Collaborator |
---|---|
University of Denver |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | NSSI Frequency in the Past 3 Months | Our primary outcome variable will compare past 3-month NSSI frequency at 3-month follow-up-for participants assigned to the Project SAVE SSI versus supportive therapy SSI (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 NSSI 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 NSSI in the previous 3 months in the earlier question). | 3 months post-intervention | |
Secondary | Likelihood of Future NSSI. | Likelihood of future NSSI will be measured immediately pre- and post-intervention. We will evaluate self-reported likelihood of future non-suicidal self-injury immediately post-intervention-comparing participants in the Project SAVE SSI versus supportive therapy SSI control conditions, and controlling for pre-intervention likelihood score. An item from the Self-Injurious Thoughts and Behaviors Interview-R (Fox et al., 2020) will assess participants' beliefs about the likelihood of future non-suicidal self injury on a 5-point Likert Scale (range = 0 to 4; 0 = "not at all"; 4 = "extremely"). | immediately post-intervention | |
Secondary | Suicide ideation | We will compare past 3-month SI frequency at 3-month follow-up-for participants assigned to the Project SAVE SSI versus supportive therapy SSI (i.e. control condition). At pre-intervention and 3-month follow-up time points, participants will indicate "how many days did they have thoughts about killing themselves for more than a few minutes" 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 history of SI (via a previous question) skip to the end of the question block and are not prompted to answer our frequency outcome question. For these individuals, we will impute a past 3-month frequency value equal to 0 (as they have endorsed zero SI in the previous question). More information about how we will handle very large numbers (i.e. outliers) for this outcome is reported below (see "Outliers and Exclusions" section; "Winsorizing Outliers" subsection). | 3 months post-intervention |
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