Trial Outcomes & Findings for Single-Session Intervention Targeting Self-Injurious Behavior in Adolescents (NCT NCT04498143)
NCT ID: NCT04498143
Last Updated: 2024-12-10
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
565 participants
Primary outcome timeframe
Baseline & 3 months post-intervention
Results posted on
2024-12-10
Participant Flow
Participant milestones
| Measure |
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.
Project SAVE ("Stop Adolescent Violence Everywhere") SSI: Internet-based, 30-minute single session intervention targeting NSSI via decreasing urge to act on self-punishment/self-harm thoughts/urges.
|
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.
Active Comparator: Supportive Therapy ("Share Your Feelings") SSI: Internet-based, 30-minute single session intervention to increase feelings disclosure.
|
|---|---|---|
|
Overall Study
STARTED
|
286
|
279
|
|
Overall Study
COMPLETED
|
232
|
220
|
|
Overall Study
NOT COMPLETED
|
54
|
59
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Single-Session Intervention Targeting Self-Injurious Behavior in Adolescents
Baseline characteristics by cohort
| Measure |
Project SAVE ("Stop Adolescent Violence Everywhere") SSI
n=286 Participants
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.
Project SAVE ("Stop Adolescent Violence Everywhere") SSI: Internet-based, 30-minute single session intervention targeting NSSI via decreasing urge to act on self-punishment/self-harm thoughts/urges.
|
Supportive Therapy ("Share Your Feelings") SSI
n=279 Participants
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.
Active Comparator: Supportive Therapy ("Share Your Feelings") SSI: Internet-based, 30-minute single session intervention to increase feelings disclosure.
|
Total
n=565 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
286 Participants
n=5 Participants
|
279 Participants
n=7 Participants
|
565 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
189 Participants
n=5 Participants
|
186 Participants
n=7 Participants
|
375 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
24 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Transgender
|
22 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female to male transgender (FTM)
|
16 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Trans male
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Trans masculine
|
13 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Trans feminine
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Genderqueer
|
14 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender expansive
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Intersex
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Androgynous
|
19 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Nonbinary
|
61 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Two-spirited
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Third gender
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Agender
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Not sure
|
34 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Other/Not listed
|
17 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Missing
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
12 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian (including Asian Desi)
|
16 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/African-American
|
25 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latinx
|
59 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
220 Participants
n=5 Participants
|
204 Participants
n=7 Participants
|
424 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Prefer not to answer
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other/Not Listed
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
286 Participants
n=5 Participants
|
279 Participants
n=7 Participants
|
565 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline & 3 months post-interventionOur 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).
Outcome measures
| Measure |
Project SAVE ("Stop Adolescent Violence Everywhere") SSI
n=286 Participants
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.
Project SAVE ("Stop Adolescent Violence Everywhere") SSI: Internet-based, 30-minute single session intervention targeting NSSI via decreasing urge to act on self-punishment/self-harm thoughts/urges.
|
Supportive Therapy ("Share Your Feelings") SSI
n=279 Participants
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.
Active Comparator: Supportive Therapy ("Share Your Feelings") SSI: Internet-based, 30-minute single session intervention to increase feelings disclosure.
|
|---|---|---|
|
Nonsuicidal Self-injury Frequency in the Past 3 Months
Nonsuicidal self-injury Frequency for Past 3 Months (baseline)
|
15.81 Nonsui behaviors (i.e., number of times)
Standard Deviation 16.98
|
13.93 Nonsui behaviors (i.e., number of times)
Standard Deviation 15.36
|
|
Nonsuicidal Self-injury Frequency in the Past 3 Months
Nonsuicidal self-injury Frequency for Past 3 Months (follow-up)
|
22.72 Nonsui behaviors (i.e., number of times)
Standard Deviation 21.87
|
23.85 Nonsui behaviors (i.e., number of times)
Standard Deviation 22.10
|
SECONDARY outcome
Timeframe: baseline & immediately post-interventionLikelihood 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").
Outcome measures
| Measure |
Project SAVE ("Stop Adolescent Violence Everywhere") SSI
n=286 Participants
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.
Project SAVE ("Stop Adolescent Violence Everywhere") SSI: Internet-based, 30-minute single session intervention targeting NSSI via decreasing urge to act on self-punishment/self-harm thoughts/urges.
|
Supportive Therapy ("Share Your Feelings") SSI
n=279 Participants
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.
Active Comparator: Supportive Therapy ("Share Your Feelings") SSI: Internet-based, 30-minute single session intervention to increase feelings disclosure.
|
|---|---|---|
|
Likelihood of Future NSSI (Mean Difference From Pre- to Post-intervention).
|
-0.63 score on a scale
Standard Error 0.06
|
-0.40 score on a scale
Standard Error 0.06
|
SECONDARY outcome
Timeframe: Baseline & 3 months post-interventionWe will compare past 3-month SI frequency (# of days) at 3-mo follow-up-for participants assigned to 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).
Outcome measures
| Measure |
Project SAVE ("Stop Adolescent Violence Everywhere") SSI
n=286 Participants
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.
Project SAVE ("Stop Adolescent Violence Everywhere") SSI: Internet-based, 30-minute single session intervention targeting NSSI via decreasing urge to act on self-punishment/self-harm thoughts/urges.
|
Supportive Therapy ("Share Your Feelings") SSI
n=279 Participants
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.
Active Comparator: Supportive Therapy ("Share Your Feelings") SSI: Internet-based, 30-minute single session intervention to increase feelings disclosure.
|
|---|---|---|
|
Suicide Ideation
SI Frequency for Past 3 Months (baseline)
|
24.74 suicidal thought (i.e., number of days)
Standard Deviation 28.78
|
24.00 suicidal thought (i.e., number of days)
Standard Deviation 29.94
|
|
Suicide Ideation
SI Frequency for Past 3 Months (follow-up)
|
35.73 suicidal thought (i.e., number of days)
Standard Deviation 29.14
|
31.54 suicidal thought (i.e., number of days)
Standard Deviation 26.95
|
Adverse Events
Project SAVE ("Stop Adolescent Violence Everywhere") SSI
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Supportive Therapy ("Share Your Feelings") SSI
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place