Status:
COMPLETED
Single-Session Intervention Targeting Self-Injurious Behavior in Adolescents
Lead Sponsor:
University of Denver
Conditions:
Nonsuicidal Self Injury
Self Hatred
Eligibility:
All Genders
13-16 years
Phase:
NA
Brief 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 on...
Detailed Description
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 relative...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
August 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 14 2021
Estimated Enrollment :
565 Patients enrolled
Trial Details
Trial ID
NCT04498143
Start Date
August 18 2020
End Date
April 14 2021
Last Update
December 10 2024
Active Locations (1)
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1
University of Denver (though recruitment takes place online)
Denver, Colorado, United States, 80210