Single-Session Intervention Targeting Self-Injurious Behavior in Adolescents

NCT04498143 | Completed Results

• 1 other identifier: 1505797-4
• Study Type: interventional
• Target: 565
• Locations: 1 country
• Sites: 1

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 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. 1.Reductions in NSSI 3 months post-treatment \[primary outcome\]
2. 2.Reductions in self-reported likelihood of future NSSI immediately post-treatment \[secondary outcome\]
3. 3.Reduction in suicide ideation frequency 3 months post-treatment \[secondary outcome\]

Conditions

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

Keywords

adolescents; online

Outcome Measures

Primary Outcomes (1)

• Nonsuicidal Self-injury Frequency in the Past 3 Months

  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).

  Baseline & 3 months post-intervention

Secondary Outcomes (2)

• Likelihood of Future NSSI (Mean Difference From Pre- to Post-intervention).

  baseline & immediately post-intervention

• Suicide Ideation

  Baseline & 3 months post-intervention

Study Arms (2)

Project SAVE ("Stop Adolescent Violence Everywhere") SSI

EXPERIMENTAL

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.

Other: Project SAVE ("Stop Adolescent Violence Everywhere") SSI

Supportive Therapy ("Share Your Feelings") SSI

ACTIVE COMPARATOR

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.

Other: Active Comparator: Supportive Therapy ("Share Your Feelings") SSI

Interventions

Project SAVE ("Stop Adolescent Violence Everywhere") SSI OTHER

Internet-based, 30-minute single session intervention targeting NSSI via decreasing urge to act on self-punishment/self-harm thoughts/urges.

Project SAVE ("Stop Adolescent Violence Everywhere") SSI

Active Comparator: Supportive Therapy ("Share Your Feelings") SSI OTHER

Internet-based, 30-minute single session intervention to increase feelings disclosure.

Supportive Therapy ("Share Your Feelings") SSI

Eligibility Criteria

• Age: 13 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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.
• (for one example, see Schleider \& Weisz, 2018: https://doi.org/10.1080/15374416.2017.1405353)

Sponsors & Collaborators

• University of Denver: lead

Study Sites (1)

University of Denver (though recruitment takes place online)

Denver, Colorado, 80210, United States

Location

Related Publications (1)

• Dobias ML, Schleider JL, Jans L, Fox KR. An online, single-session intervention for adolescent self-injurious thoughts and behaviors: Results from a randomized trial. Behav Res Ther. 2021 Dec;147:103983. doi: 10.1016/j.brat.2021.103983. Epub 2021 Oct 7.

  PMID: 34688102 DERIVED

MeSH Terms

Conditions

Self-Injurious Behavior; Suicidal Ideation; Suicide, Attempted

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Suicide

Limitations and Caveats

Several limitations of this trial (like all trials). For example, retention rates at follow-up were lower than anticipated.

Results Point of Contact

• Title: Dr. Kathryn Fox
• Organization: University of Denver

Kathryn.Fox@du.edu

3015202715

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: We will use a between-subjects design. Adolescents (13-16) recruited online via social media who report elevated self-hate and past month engagement in nonsuicidal self-injury will be randomized to the SAVE (active) or psychotherapy support (control)-SSI.

Study Record Dates

• First Submitted: July 30, 2020
• First Posted: August 4, 2020
• Study Start: August 18, 2020
• Primary Completion: January 15, 2021
• Study Completion: April 14, 2021
• Last Updated: December 10, 2024
• Results First Posted: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Upon submission of the manuscript to a peer-reviewed journal. The data will be available open access thereafter.
• Access Criteria: The de-identified data will be shared open access

Locations

US (1)