Preventing Suicide With Safe Alternatives for Teens and Youths (SAFETY) (SAFETYF2022)

Region Stockholm

Status: Completed

Conditions: Suicide and Self-harm

Treatments: Behavioral: Supportive Therapy; Behavioral: Safe Alternatives for Teens and Youths (SAFETY)

Study type: Interventional

Funder types: Other

Identifiers

NCT05537623

SAFETY

Details and patient eligibility

About

Suicide is the leading cause of death in the age span 10-19 years in Sweden. The most robust predictor of future suicide attempt and suicide death is prior suicide attempt. Yet, most youths presenting with suicidal behavior to the Child and Adolescent Mental Health Services (CAMHS) in Stockholm, Sweden are not offered evidence-based care directly targeting suicide risk. Safe Alternatives for Teens and Youths (SAFETY) is a novel scalable suicide prevention program designed to fill this critical gap. SAFETY is a cognitive behavioral family treatment incorporating elements from Dialectical Behavior Therapy and Multisystemic Therapy. SAFETY has shown promise in reducing suicide attempts in two small-N trials. In a randomized controlled feasibility trial, the investigators will examine the feasibility of SAFETY and an active control condition named Supportive Therapy at post-treatment, 3 and 12 months after treatment on youth suicidal behavior. Evaluations of feasibility, acceptability, and safety based on data from this pilot trial will guide and inform the design of a full-scale randomized controlled trial.

Full description

Research questions:

1. Is it feasible (operationalized as participation in treatment, completed homework assignments, reported adverse events) to offer SAFETY to youths with suicidal behavior and their caregivers within the CAMHS?
2. Is it feasible (operationalized as participation in treatment, completed homework assignments, reported adverse events) to offer Supportive Therapy as an active control treatment to youths with suicidal behavior and their caregivers within the CAMHS?
3. Is the planned procedure and design (recruitment, blinded assessors, randomization and data attrition) of the study feasible?
4. What are the proportions of suicidal behavior in the group randomized to SAFETY group and the group randomized to Supportive Therapy, respectively?
5. Is participation in SAFETY and Supportive Therapy associated with improved emotion regulation, perceived social support, and family function, and how large are the effects (suggested treatment processes)?
6. Is participation in SAFETY and Supportive Therapy associated with improvements in nonsuicidal self-injury, depression, anxiety, and other outcomes, and how large are the effects (outcomes)?
7. How do the youths and caregivers experience participation in SAFETY and Supportive Therapy, respectively?

Enrollment: 30 patients

Sex: All

Ages: 10 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Suicidal behavior (defined as suicide attempt, interrupted suicide attempt, aborted suicide attempt, or preparatory behavior) in the last 3 months
• Age 10-17 years
• At least one primary caregiver willing to participate in treatment

Exclusion criteria

• Symptoms requiring other immediate treatment (e.g. psychosis, severe anorexia nervosa)
• Ongoing treatment with DBT
• Individual or life circumstances that could complicate or make treatment participation impossible, or that require immediate intervention (e.g., violence in close relationships; intellectual disability)
• Insufficient understanding of the Swedish language

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Safe Alternatives for Teens and Youths (SAFETY)

Experimental group

Description:

SAFETY is a transdiagnostic cognitive-behavioral family treatment informed by Dialectical Behavior Therapy (DBT) and Multisystemic Therapy (MST). The twelve week long treatment is principle based, structured in phases, and individually tailored based on a cognitive-behavioral fit analysis that specifies key risk and protective processes. Each session contains one individual component for youth and parents respectively, and one family component where youth and parents work together with therapists to practice skills identified as critical for preventing future suicidal behavior. Treatment targets are arranged in a SAFETY Pyramid, consisting of (a) safe settings; (b) safe people; (c) safe activities and actions; (d) safe thought; and (e) safe stress reactions, emphasizing strengthening protective support and validation within the family and/or social environment surrounding the youth.

Treatment:

Behavioral: Safe Alternatives for Teens and Youths (SAFETY)

Supportive Therapy

Active Comparator group

Description:

Supportive Therapy is a manualized client-centered therapy. The Supportive Therapy will be adapted to match SAFETY to control for nonspecific treatment factors such as therapist characteristics, time, and treatment exposure. The Supportive Therapy program consists of twelve weekly individual sessions with the youth, focusing on the therapeutic supporting relationship between the therapist and the youth, and follow-ups with parents. Therapeutic strategies include acceptance and validation, to increase feelings of connectedness and belonging and counteract thwarted belongingness, helplessness, and hopelessness. Cognitive-behavioral techniques (e.g., active modeling, problem-solving training, cognitive restructuring) are not allowed.

Treatment:

Behavioral: Supportive Therapy