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Self Injurious BehaviorNCT07913425

Examining the Effectiveness of a Brief Therapeutic Intervention for Reducing Self-Harm Among Adolescents

A study testing Cutting Down Program - a three-month cognitive-behavioral psychotherapy focused on reducing self-injury urges and behaviors in adolescents in people with Self Injurious Behavior and Self Injurious Behavior Without Suicidal Intent, run by University of Haifa at 1 site in Israel.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Non-suicidal self-injury (NSSI), defined as deliberate self-inflicted destruction of body tissue without intent to die, is particularly prevalent during mid-adolescence, with prevalence estimated around 16-22% in community samples. Although distinct from suicidality, NSSI is a strong predictor of suicidal attempts. Read more about this study

Who is it for?
Ages 12 to 18 years
What is being tested?
Cutting Down Program - a three-month cognitive-behavioral psychotherapy focused on reducing self-injury urges and behaviors in adolescents
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteIsrael
Study dates
10 Nov 2026to 30 Sep 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 12 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • At least one active self-injurious behavior during the past 6 months, prior to beginning of treatment.
  • Both adolescent and participating parent are fluent in Hebrew

Who cannot join

  • Active psychosis
  • Substance use disorder
  • Cognitive impairments precluding understanding of consent or research questions or adhering to the treatment.
  • Altered levels of consciousness
  • Linguistic limitations precluding understanding of consent or research questions or adhering to the treatment.
  • Patients whose parents/legal guardians cannot comply with study requirements.
Show all 10Show fewer
  • Necessity of psychiatric treatment due to depression/suicidality
  • Severe suicidality (active suicidal intents)
  • Severe depression
  • A history of mental health diagnoses and/or hospitalizations.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Adva Eichengreen, PhD contact

972-506044818

adva.eichengreen@gmail.com

Israel1 site
  • Psychological and Counseling Services (SHEFI)

    Tel Aviv

    Yael Shahar National Coordinator for Depression and Suicide Prevent, +972-50-744-0071, yaelshahars@gmail.com

Other trials in Israel

About this study

Official title: Examining the Effectiveness of a Brief Therapeutic Intervention for Reducing Self-harm Among Adolescents

Non-suicidal self-injury (NSSI), defined as deliberate self-inflicted destruction of body tissue without intent to die, is particularly prevalent during mid-adolescence, with prevalence estimated around 16-22% in community samples. Although distinct from suicidality, NSSI is a strong predictor of suicidal attempts. Yet intervention studies addressing self-injury urges and behaviors in youth remain scarce. The Cutting Down Program (CDP) is currently one of the most promising interventions for adolescents who self-harm. This three-month intervention, evidenced in a randomized controlled trial, integrates techniques from cognitive-behavioral (CBT) and dialectic-behavioral (DBT) therapies. Recently, an updated CDP protocol was developed to more directly address suicidality and involve parents in the treatment. This study will test the updated protocol with a sample of adolescents who self-harm, recruited from schools and treated by educational psychologists of the Israeli Psychological and Counseling Services (SHEFI). We will examine the intervention's effects on mental health outcomes (e.g., self-injury) and on potential mediators (emotion regulation and parental emotion socialization), to clarify its mechanisms of change.

Read the detailed description

The intervention's effects will be assessed in a pilot sample of 40 adolescents aged 12-18. Adolescents identified by school counselors as engaging in self-injury will be referred to SHEFI nationwide, as part of routine assessment and treatment procedures. Twenty expert educational psychologists trained in the CDP will each treat two adolescents. Following an initial intake, the adapted CDP includes 14 weekly sessions over three months: 12 with the adolescent and 3 with the parents. A final follow-up session (session 15) will be held with the adolescent and their parents three months after the end of treatment. Adolescents and one parent (the same parent throughout) will complete self-report questionnaires at four time points: before treatment, after the second parent session (2 months), towards the end of treatment (3 months), and at follow-up (6 months).

All therapists in the study are expert educational psychologists. They will complete a two-day training led by the principal investigator (senior researcher and a clinical psychology experienced with the CDP) and an educational psychologist experienced in the CDP. Following this training, they will take part in year-long group supervision in small groups every two weeks, led by clinical or educational psychologists experienced with the CDP, which will serve as a space for consultation. All training and supervision will be conducted online to allow nationwide participation. Treatment sessions will take place in person at local SHEFI branches.

Being tested
Cutting Down Program - a three-month cognitive-behavioral psychotherapy focused on reducing self-injury urges and behaviors in adolescents
Keywords
self injury, suicidality, depressive symptoms, adolescents, emotion regulation, parental emotion socialization
Medical subject headings
Self-Injurious Behavior, Suicidal Ideation, Depression, Emotional Regulation

What participants receive

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

  • Cutting Down Program - a three-month cognitive-behavioral psychotherapy focused on reducing self-injury urges and behaviors in adolescentsBehavioural

    The CDP protocol in this project consists of 12 weekly individual 50-minute sessions, three parents sessions and one follow-up meeting with the family. Modules include: 1. Psychoeducation about self-injury, understanding personalized functions of self-injury, discussing motivation for change, risk assessment for suicidality and safety plan. 2. Emotional identification and management, activities scheduling, identifying and managing negative thoughts and self-judgment, and committing to goals. 3. Coping strategies, including problem solving, assertiveness, management of anxiety, anger or hopelessness, mindfulness, emotion regulation and alternatives for self-injury. 4. Progress review, identifying triggers and reinforcing coping strategies to maintain progress and post-treatment. Parents meetings focus on psychoeducation about self-injury and skills for emotion validation and support of alternatives to self-injury. The third session involves both parents and adolescents, emphasizing pare

Study groups in NCT07913425
Study groupRoleWhat they receive
Cutting Down ProgramExperimentalPsychotherapeutic treatment
Receives: Behavioral: Cutting Down Program - a three-month cognitive-behavioral psychotherapy focused on reducing self-injury urges and behaviors in adolescents

What is being measured

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

  1. Self injury behaviors

    Deliberate Self-Harm Inventory (DSHI): A 6-item self-report assessing the frequency of different types of non-suicidal self-injury behaviors adapted for the last month. The items are rated from 1 (not at all) to 5 (5 times or more), with the request to enter the exact number of self harm behaviors if participant selected any option that is more than 1. The minimum sum score is 6, and the maximun depends on the exact number of self harm behaviors the participant reports, with higher number indicates higher fequency of non-suicidal self injurious behaviors.

    The scale will also be administered one time before the beginning of the treatment asking about the last 6 months, using only the 1-5 item rating (min sum score: 6, max sum score: 30).

    The version asking about the last month will be administered at four time points as described in the Time Frame.

    Measured: (1) Before the first treatment meeting (2) 2 months after the treatment starts (after the 2nd parent session), (3) 3 months after the treatment starts (towards the end of the treatment), (4) 3 months after the end of the treatment (follow up).

  2. Self injury thoughts

    Alexian Brothers Urge to Self-Injure Scale (ABUSI). A 5-item self-report addressing frequency and intensity of urges to self-injure in the past week. Each item is rated from 1 (not at all) to 7 (almost all the time/strong intensity of urges). The minimal sum score is 5 and the maximal is 35, with higher scores indicating higher frequency and intensity of urges to self-injure.

    Measured: (1) Before the first treatment meeting (2) 2 months after the treatment starts (after the 2nd parent session), (3) 3 months after the treatment starts (towards the end of the treatment), (4) 3 months after the end of the treatment (follow up).

Secondary outcomes (4)
  1. Suicidal thoughts and behaviors

    Columbia Suicide Severity Rating Scale, Child Version (C-SSRS). A 7-item self-report assessing incidence and severity of suicidal thoughts and behaviors. The first six items, scored as 0 (no) or 1 (yes), ask about the last two weeks, and the seventh item is an open question asking about the number of suicidal behaviors in the last month. The scale's score is the highest item endorsed among the first six items. Minimum score is 0 and maximum score is 6, with higher score indicating greater severity of suicidal thoughts and behaviors.

    Measured: (1) Before the first treatment meeting (2) 2 months after the treatment starts (after the 2nd parent session), (3) 3 months after the treatment starts (towards the end of the treatment), (4) 3 months after the end of the treatment (follow up).

  2. Depressive symptoms

    Short Mood and Feelings Questionnaire (SMFQ); A 13-item self report assessing the the respondent's recent feelings and behaviors, focusing on depressive symptoms in the last two weeks. Each item is rated from 0 (untrue) to 2 (true). The sum score can range from 0 to 26, with higher score indicating more depressive symptoms.

    Measured: (1) Before the first treatment meeting (2) 2 months after the treatment starts (after the 2nd parent session), (3) 3 months after the treatment starts (towards the end of the treatment), (4) 3 months after the end of the treatment (follow up).

  3. Emotion dysregulation

    Difficulties in Emotion Regulation Scale (DERS) - short version. An 18-item self-report assessing difficulties in regulating emotional distress. Key dimensions include nonacceptance of emotions, and difficulties in goal-directed behavior, impulse control, emotion awareness and clarity, and in use of regulation strategies. Each item is rated from 1 (almost never) to 5 (almost always). The sum score can range from 18 to 90, with higher score indicating more emotion dysregulation.

    Measured: (1) Before the first treatment meeting (2) 2 months after the treatment starts (after the 2nd parent session), (3) 3 months after the treatment starts (towards the end of the treatment), (4) 3 months after the end of the treatment (follow up).

  4. Parental emotion socialization

    Coping with Children's Negative Emotions Scale, measured in two versions: a. Adolescents' Perceptions of Parent (CCNES-APP). b. CCNES-A parent's perception. Each version includes the same nine scenarios depicting adolescents' emotional distress, for which respondents select the parent's responses. Responses range from validating, expressive encouragement, emotion- focus reactions and problem-focus reactions, to distress , minimizing or punitive reactions. There are seven possible parental responses to each of the 9 scenarios, with each response rated from 1 (very unlikely) to 7 (very likely). The final score is divided into two average scores: supportive responses and unsupportive responses. Each score can range from 1 to 7, with higher score indicating greater likelihood that parents use this type of responses. Parents and adolescent versions will be computed separately to create distinct informant scores on parental emotion socialization.

    Measured: (1) Before the first treatment meeting (2) 2 months after the treatment starts (after the 2nd parent session), (3) 3 months after the treatment starts (towards the end of the treatment), (4) 3 months after the end of the treatment (follow up).

Timeline

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

  1. First posted3 Nov 2026
  2. Study start10 Nov 2026 (estimated)
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Sep 2027 (estimated)

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
Not applicable
Intervention model
Single group
Model description
Single-arm pre-post design with a three-month follow-up
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07913425
Sponsor's protocol ID
083-25
Status last verified
Nov 2026
First submitted
26 Oct 2026
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Only IPD used in the results publication - upon request or through the university repository. Study design and planned statistical analyses will be registered in OSF on Nov. 2026

Publications

  • Plener PL, Schumacher TS, Munz LM, Groschwitz RC. The longitudinal course of non-suicidal self-injury and deliberate self-harm: a systematic review of the literature. Borderline Personal Disord Emot Dysregul. 2015 Jan 30;2:2. doi: 10.1186/s40479-014-0024-3. eCollection 2015.

    PubMed 26401305
  • Ohlis A, Li L, Kuja-Halkola R, Lundstrom S, D'Onofrio BM, Hellner C, Lichtenstein P, Cederlof M, Chang Z, Bjureberg J. Genetic and environmental aetiologies of the transition from nonsuicidal self-injury to suicide attempt: a longitudinal twin study. Mol Psychiatry. 2025 Dec;30(12):5828-5832. doi: 10.1038/s41380-025-03165-z. Epub 2025 Aug 22.

    PubMed 40847004
  • Moloney F, Amini J, Sinyor M, Schaffer A, Lanctot KL, Mitchell RHB. Sex Differences in the Global Prevalence of Nonsuicidal Self-Injury in Adolescents: A Meta-Analysis. JAMA Netw Open. 2024 Jun 3;7(6):e2415436. doi: 10.1001/jamanetworkopen.2024.15436.

    PubMed 38874927
  • Farkas BF, Takacs ZK, Kollarovics N, Balazs J. The prevalence of self-injury in adolescence: a systematic review and meta-analysis. Eur Child Adolesc Psychiatry. 2024 Oct;33(10):3439-3458. doi: 10.1007/s00787-023-02264-y. Epub 2023 Jul 24.

    PubMed 37486387
  • Clareus B, Lundh LG, Wangby-Lundh M, Bjarehed J, Daukantaite D. Time trends in non-suicidal self-injury, disordered eating, and mental health problems between 2007 and 2025: a comparison of two Swedish adolescent cohorts. Eur Child Adolesc Psychiatry. 2026 Oct;35(10):3325-3334. doi: 10.1007/s00787-026-03105-4. Epub 2026 Jun 22.

    PubMed 42329373
  • Taylor, L., Simic, M., & Schmidt, U. (2022). Cutting Down: An Evidence-based CBT Workbook for Treating Young People Who Self-Harm. Routledge.

  • Kaess M, Edinger A, Fischer-Waldschmidt G, Parzer P, Brunner R, Resch F. Effectiveness of a brief psychotherapeutic intervention compared with treatment as usual for adolescent nonsuicidal self-injury: a single-centre, randomised controlled trial. Eur Child Adolesc Psychiatry. 2020 Jun;29(6):881-891. doi: 10.1007/s00787-019-01399-1. Epub 2019 Sep 11.

    PubMed 31512050
  • Taylor LM, Oldershaw A, Richards C, Davidson K, Schmidt U, Simic M. Development and pilot evaluation of a manualized cognitive-behavioural treatment package for adolescent self-harm. Behav Cogn Psychother. 2011 Oct;39(5):619-25. doi: 10.1017/S1352465811000075. Epub 2011 Mar 11.

    PubMed 21392417

Questions about this trial

What is this clinical trial studying?

A study testing Cutting Down Program - a three-month cognitive-behavioral psychotherapy focused on reducing self-injury urges and behaviors in adolescents in people with Self Injurious Behavior and Self Injurious Behavior Without Suicidal Intent, run by University of Haifa at 1 site in Israel.

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 2 inclusion and 10 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: opening soon, as of the sponsor's last update on 3 Nov 2026. 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 Israel. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Adva Eichengreen, PhD (972-506044818, adva.eichengreen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Self injury behaviors (time frame: (1) Before the first treatment meeting (2) 2 months after the treatment starts (after the 2nd parent session), (3) 3 months after the treatment starts (towards the end of the treatment), (4) 3 months after the end of the treatment (follow up).). The study lists 2 primary outcomes in all. 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 NCT07913425, which also lists 8 linked publications.

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 3 Nov 2026.

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