AzTrials
AzTrials

Nonsuicidal Self InjuryProject SAVENCT04498143

Single-Session Intervention Targeting Self-Injurious Behavior in Adolescents

A study testing Project SAVE ("Stop Adolescent Violence Everywhere") SSI and Active Comparator: Supportive Therapy ("Share Your Feelings") SSI in people with Nonsuicidal Self Injury and Self Hatred, run by University of Denver at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 13 to 16 yearsHealthy volunteers can take part
What is being tested?
Project SAVE ("Stop Adolescent Violence Everywhere") SSI and Active Comparator: Supportive Therapy ("Share Your Feelings") SSI
Could I receive a placebo?
No, everyone receives an active treatment
How many people
565 participants
Where
1 siteUnited States
Study dates
18 Aug 2020to 14 Apr 2021
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 16 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 11Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Denver (though recruitment takes place online)

    Denver, Colorado, 80210

Other trials in United States

About this study

Official title: Evaluating an Online, Single-Session Intervention Targeting Self-Injurious Behavior in Adolescents

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]
Read the 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 relatively rare during childhood but increase significantly during the transition to adolescence. Self-injurious thoughts and behaviors (SITBs), which include suicidal thoughts and behaviors and nonsuicidal self-injury (NSSI; intentional self-harm enacted without suicidal intent), are among the best predictors of future suicidal thoughts and attempts in the current state of literature on the topic. There is also significant escalation from suicidal thoughts to suicidal behaviors during this developmental period. Most youth who transition from suicidal thoughts to suicidal behaviors will do so within 1-2 years after the onset of suicide ideation, which tends to begin in adolescents. Taken together, adolescence is a key developmental period for effective depression and suicide intervention and prevention. The goal of these studies is to test Single Session Interventions (SSIs) (defined below) that are designed to boost coping and resilience in adolescents. The investigators hope that this research will be valuable in ensuring that these SSIs are accessible to more adolescents.

Despite significant strides in the development of psychosocial treatments for youth mental health problems, up to 80% of youth in the United States with mental health needs receive no services at all. Even when services are accessed, the definition of "treatment" is incredibly broad, with evidence-based interventions being the exception, not the rule. More typically, "treatment" may involve a single, unstructured contact with a medical doctor, counselor, emergency hotline, religious leader, or other health professional (e.g., occupational therapist), the benefits of which are unknown.

This reality poses a critical challenge to the field of clinical intervention science-one that has been articulated many times before. Eight years ago, Kazdin and Blase (2011) called for a "rebooting" of psychotherapy research and practice, stating that "mental health professionals are not likely to reduce the prevalence, incidence, and burden of mental illness without a major shift in intervention research and clinical practice" via a portfolio of novel approaches to service delivery. Yet again, Kazdin (2019) asked us to reconsider how psychotherapy can and should be delivered: He argues that without removing requirements of a face-to-face format, an 'expert' with years of training, and a physical office, the need-to-access gap will likely stay stagnant. Indeed, Kazdin (2019) asserts the need to think about therapeutic action through an entirely new lens, asserting that "interventions may or may not rely on the psychological treatments that continue to dominate research."

Any action-focused path to reducing the need-to-access gap will require moving beyond the dominant settings, formats, and systems that have constrained intervention delivery to date. Indeed, as Chorpita (2019) asserts, "it may well be time we move past thinking about 'treatments' as our only form of solutions" (p. 475), with "treatments" referencing the dominant design of current psychosocial therapies: weekly, clinician-delivered interventions in brick-and mortar clinical settings, which are too often inaccessible to those they are designed to serve.

Brief, online interventions:

Even among youths who do access services, treatment is often brief: U.S. youths who begin therapy attend an average of ~4 sessions, and the modal number of sessions attended is one. This creates a need to quantify and capitalize on what can be accomplished, given appropriate targeting and structure, in a short period of time.

Single-session interventions (SSIs) have been found to benefit youth and help reduce depression symptoms. SSIs are brief and could be easily accessed online, thus, potentially limiting barriers to accessing treatment. Therefore, SSIs could markedly increase the capacity to address teen mental illness and SITBs in a cost-effective manner (Barak \& Grohol, 2011). Indeed, SSIs can successfully reduce mental health problems: In a meta-analysis of 50 randomized trials including 10,508 youth participants (ages 4-19) SSIs significantly reduced psychopathology of multiple types (mean g = 0.32), including self-administered SSIs-those that did not involve a therapist (e.g., online SSIs; mean g = 0.32). To date, two types of SSIs have been shown to reduce depressive symptoms in adolescents and/or young adults. However, only one of these two SSIs is designed for online administration (the other is administered by a therapist and therefore more challenging to disseminate). In the present series of studies, the investigators aim to test the efficacy of SSIs self-administered online to reduce depression and SITBs in a large sample of teenagers.

The Current Research

The goal of this study is to test single session interventions (SSIs) that are designed to boost coping and resilience in adolescents. Specifically, participants (aged 13-16) will be randomized to: (1) an online, active control group program encouraging feelings disclosure (i.e. supportive therapy SSI), or (2) an online program targeting nonsuicidal self-injurious behavior (i.e. Project "SAVE"-Stop Adolescent Violence Everywhere-SSI).

The investigators will test whether participants randomized to the SAVE SSI report:

  1. Lower self-reported likelihood of future NSSI immediately post-intervention
  2. Lower self-reported frequency of non-suicidal self-injury (in the past 3 months) at 3 month follow-up
  3. Lower self-reported frequency of suicide ideation (in the past 3 months) at 3 month follow-up
Being tested
Project SAVE ("Stop Adolescent Violence Everywhere") SSI, Active Comparator: Supportive Therapy ("Share Your Feelings") SSI
Keywords
adolescents, online
Medical subject headings
Self-Injurious Behavior, Suicidal Ideation, Suicide, Attempted

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Project SAVE ("Stop Adolescent Violence Everywhere") SSIOther

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

  • Active Comparator: Supportive Therapy ("Share Your Feelings") SSIOther

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

Study groups in NCT04498143
Study groupRoleWhat they receive
Project SAVE ("Stop Adolescent Violence Everywhere") SSIExperimentalSAVE 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.
Receives: Other: Project SAVE ("Stop Adolescent Violence Everywhere") SSI
Supportive Therapy ("Share Your Feelings") SSIActive comparatorSupportive 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.
Receives: Other: Active Comparator: Supportive Therapy ("Share Your Feelings") SSI

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Baseline & 3 months post-intervention

Secondary outcomes (2)
  1. Likelihood of Future NSSI (Mean Difference From Pre- to Post-intervention).

    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").

    Measured: baseline & immediately post-intervention

  2. Suicide Ideation

    We 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).

    Measured: Baseline & 3 months post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2020
  2. Study start18 Aug 2020
  3. Primary completion15 Jan 2021
  4. Study completion14 Apr 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
565 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04498143
Sponsor's protocol ID
1505797-4
Acronym
Project SAVE
Status last verified
Dec 2024
First submitted
30 Jul 2020
Last updated
10 Dec 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The data will be de-identified both by removing identifying information and any other procedures necessary to keep the data from being re-identified using known methods. The independent and dependent variables relevant to the primary outcomes will be shared

Publications

  • 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.

    PubMed 34688102

Questions about this trial

What is this clinical trial studying?

A study testing Project SAVE ("Stop Adolescent Violence Everywhere") SSI and Active Comparator: Supportive Therapy ("Share Your Feelings") SSI in people with Nonsuicidal Self Injury and Self Hatred, run by University of Denver at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Nonsuicidal Self-injury Frequency in the Past 3 Months (time frame: Baseline & 3 months post-intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04498143, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in