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N/A N=565 Randomized Triple-blind Treatment

Single-Session Intervention Targeting Self-Injurious Behavior in Adolescents

Nonsuicidal Self Injury · Self Hatred · Suicidal Thoughts · Suicide Attempts

Enrolled (actual)
565
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: Nonsuicidal Self-injury Frequency in the Past 3 Months — 15.81; 13.93; 22.72; 23.85 Nonsui behaviors (i.e., number of times)

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Project SAVE ("Stop Adolescent Violence Everywhere") SSI (Other); Active Comparator: Supportive Therapy ("Share Your Feelings") SSI (Other)
Age
Pediatric · 13+ yrs
Sex
All
Sponsor
University of Denver
Primary completion
Jan 2021

Outcome Measures

OutcomeResultp-value
PRIMARY
Nonsuicidal Self-injury Frequency in the Past 3 Months
15.81; 13.93; 22.72; 23.85
SECONDARY
Likelihood of Future NSSI (Mean Difference From Pre- to Post-intervention).
-0.63; -0.40
SECONDARY
Suicide Ideation
24.74; 24.00; 35.73; 31.54

Summary

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]

Eligibility Criteria

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04498143). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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