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

Suicide and Self-harm Clinical Trial

— SAFETYF2022  

Official title:

Preventing Suicide With Safe Alternatives for Teens and Youths (SAFETY) - A Randomized Controlled Feasibility Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05537623
• Other study ID #: SAFETY
• Status: Recruiting
• Phase: N/A
• Start date: December 2, 2022
• Est. completion date: December 2, 2024

Study information

• Verified date: December 2022
• Source: Region Stockholm
• Contact: Moa Karemyr, MSc
• Phone: +46 72-395 04 43
• Email: moa.karemyr[@]ki.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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?

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2, 2024
• Est. primary completion date: October 2, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Self-Injurious Behavior
• Suicide
• Suicide and Self-harm

Intervention

Behavioral:
• Safe Alternatives for Teens and Youths (SAFETY)
Please see description of experimental arm (arm one)
• Supportive Therapy
Please see description of active comparator arm (arm two)

Locations

Country	Name	City	State
Sweden	Stockholm Regional Council	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Region Stockholm	Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of completed assessments at week 12	Defined as number of completed assessments at end of intervention (week 12)	week 12
Primary	Number of completed assessments at 3 months follow-up	Defined as number of completed assessments 3 months after end of intervention	3 months follow-up
Primary	Number of completed assessments at 12 months follow-up	Defined as number of completed assessments 12 months after end of intervention	12 months follow-up
Primary	The fraction of eligible participants who consent to inclusion and randomization	The fraction of potential participants will be determined as the number of eligible persons compared to the number of randomized persons.	week 12
Primary	Compliance	Compliance will be defined as number of completed sessions.	week 12
Primary	Credibility/Expectancy Scale (CEQ)	The CEQ is a 6-item measure of treatment credibility and expectancy. Scale points ranges from 0-9 and 0-100%, where a higher score indicates a better outcome.	week 1 (youth and parent reported)
Primary	Client Satisfaction Questionnaire (CSQ)	The CSQ-8 is an 8-item self-rated 4-point scale, measuring different aspects of satisfaction with treatment, e.g. perception of quality of treatment, if the treatment adequately addressed their needs and overall satisfaction. Total range is 8 to 32, with higher values indicating higher satisfaction. Mean in total satisfaction scores on the CSQ-8 for each treatment group at end of treatment will be reported.	week 12 (youth and parent reported)
Primary	Adverse events	Participants are asked to report and rate the discomfort of the eventual adverse events caused by their participation in the treatment.	week 12 (youth and parent reported)
Primary	Columbia Suicide Severity Rating Scale (C-SSRS) as exploratory clinical outcome	The C-SSRS is a 22-item measure assessing the frequency and severity of suicidal ideation, suicidal behaviors, and self-harm. The C-SSRS will be administered as a clinical interview at baseline (week 0).	week 0 (clinician reported)
Primary	Columbia Suicide Severity Rating Scale (C-SSRS) as exploratory clinical outcome	See description above (outcome 9). The C-SSRS will be administered as a self-rated measure for weekly assessments during treatment.	once every week during treatment (week 1-11 after baseline; youth reported)
Primary	Columbia Suicide Severity Rating Scale (C-SSRS) as exploratory clinical outcome	See description above (outcome 9), The C-SSRS will be administered as a clinical interview.	week 12 (end of treatment; clinician reported)
Primary	Columbia Suicide Severity Rating Scale (C-SSRS) as exploratory clinical outcome	See description above (outcome 9), The C-SSRS will be administered as a clinical interview.	3 months after end of treatment (clinician reported)
Primary	Columbia Suicide Severity Rating Scale (C-SSRS) as exploratory clinical outcome	See description above (outcome 9), The C-SSRS will be administered as a clinical interview.	12 months after end of treatment (clinician reported)
Secondary	Difficulties In Emotion Regulation Scale (DERS)	The DERS is a measure of difficulties in emotion regulation, with 36 items rated on a 1-5 Likert scale, with a higher score indicating greater difficulties with emotion regulation.	Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth and parent reported)
Secondary	Brief 16-item Version of the Difficulties In Emotion Regulation Scale (DERS-16)	DERS-16 is a brief 16-item version of the DERS, see description above, with 16 items rated on a 1-5 Likert scale, with a higher score indicating greater difficulties with emotion regulation.	Change from baseline, once every week during treatment (week 1-11; youth reported)
Secondary	Cognitive Emotion Regulation Questionnaire (CERQ)	The CERQ is a measure of cognitive emotion regulation, with 36 items on a Likert scale ranging from 1-5. A higher score indicates greater difficulties with cognitive emotion regulation.	Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported)
Secondary	Behavioral Emotion Regulation Questionnaire (BERQ)	The BERQ is a measure of behavioral emotion regulation, with 20 items on a Likert scale ranging from 1-5. A higher score indicates greater difficulties with behavioral emotion regulation.	Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported)
Secondary	Emotion Beliefs Questionnaire (EBQ)	The EBQ is a measure of emotion beliefs, with 16 items on a Likert scale ranging from 1-7. A higher score indicates more maladaptive beliefs about emotions.	Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported)
Secondary	Perth Alexithymia Questionnaire (PAQ)	The PAQ is a measure of how emotions are perceived and experienced, with 24 items on a Likert scale ranging from 1-7. A higher score indicates greater difficulties related to alexithymia.	Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported)
Secondary	Multidimensional Scale of Perceived Social Support (MSPSS)	The MSPSS is a measure of perceived social support, with 12 items on a Likert scale ranging from 1-7. A higher score indicates higher level of perceived social support.	Change from baseline, once every week during treatment (week 1-11), week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported)
Secondary	Systemic Clinical Outcome and Routine Evaluation, 15 item version (SCORE-15)	The SCORE-15 is a measure of family function, with 15 items on a Likert scale ranging from 1-5. A higher score indicates greater family function.	Change from baseline, once every week during treatment (week 1-11), week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported)
Secondary	Deliberate Self-Harm Inventory - Youth version (DSHI-Y)	The DSHI-Y is a 7-item measure assessing occurrence, method, frequency of deliberate self-harm. A higher score indicates higher frequency and severity of self-harm. The DSHI-Y will be administered as a clinical interview at baseline, post and follow-up, and as a self-rated measure for weekly assessments.	Change from baseline, once every week during treatment (week 1-11), week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported)
Secondary	Revised Children's Anxiety and Depression Scale, short (RCADS-S)	The RCADS-S, a shortened version of the Spence Child Anxiety Scale, is a child self-report measure of anxiety- and depression-related psychopathology. Total range is 0-45, Likert scale ranging from 0-3, with higher values representing a worse outcome.	Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported)
Secondary	Beck's Hopelessness Scale (BHS)	The BHS is a measure of hopelessness, with 20 dichotomous "true/false" items. A higher score indicates greater difficulties related to hopelessness.	Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth and parent reported)
Secondary	1-item version of the Perceived Criticism Measure (PCM - 1 item version)	The PCM - 1 item version is a measure of expressed emotion, consisting of one question on a Likert scale ranging from 0-10, about how critical an emotionally important individual is perceived to be by the rater.	Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported)
Secondary	Borderline Symptom List Supplement (BSL-Supplement)	The BSL-Supplement is a 11-item measure of self-destructive behaviors. Higher score indicates higher frequency of self-destructive behaviors.	Change from baseline, once every week during treatment (week 1-11), week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported)
Secondary	Dialectical Behavior Therapy - Ways of Coping Checklist (DBT-WCCL)	The DBT-WCCL is a measure of use of DBT skills use and dysfunctional ways of coping with emotions. Higher average score in the skills use subscale and lower average scores in the dysfunctional coping subscales indicate greater functional coping.	Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported)
Secondary	CRAFFT	CRAFFT is a 9-item screening measure of alcohol and substance use. A higher score indicates greater difficulties related to substance use.	Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported)
Secondary	Pittsburgh Sleep Quality Index (PSQI)	The PSQI is a 18-item measure of sleep problems. A higher score indicates greater sleep problems.	Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported)
Secondary	The Coping with Children's Negative Emotions Scale - Adolescent Version (CCNES-A)	The CCNES-A is a measure of parental coping responses in response to adolescents' negative emotions. The CCNES-A version used in this trial consists of nine hypothetical scenarios accompanied by six types of responses, rated on a Likert scale ranging from 1-7.	Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (parent reported)
Secondary	Patient Health Questionnaire-9 (PHQ-9)	The PHQ-9 is a measure of depression, with 10 items on a Likert scale ranging from 0-3. Higher score indicates greater depressive symptoms.	Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (parent reported)
Secondary	Generalized anxiety disorder 7-item scale (GAD-7)	The GAD-7 is a measure of anxiety, with 7 items on a Likert scale ranging from 0-3. Higher score indicates greater anxiety symptoms.	Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (parent reported)
Secondary	The Work and Social Adjustment Scale, youth version (WSAS-Y) - adolescent and parent versions	WSAS-Y is a measure of impaired functioning in school, everyday life, friends and social life, recreation and hobbies and family and close relationships. The scale generates a global score ranging from 0 to 40, with higher scores indicating greater impairment.	Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth and parent reported)
Secondary	Trimbos/iMTA questionnaire for Costs associated with Psychiatric illness (TIC-P)	The TIC-P is a 37 item measure assessing healthcare and societal resource use, including for example items on healthcare resource use, medications, school absenteeism, and parental productivity loss. In the present trial no health economic evaluations will be conducted. Rather this instrument is included to gain feasibility data in preparation of a planned larger randomized controlled trial. Therefore, no data on TiC-P will be reported in this trial.	Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (parent reported)
Secondary	Child Health Utility 9D (CHU-9D)	The CHU-9D is a measure of health related quality of life, with 9 items on a Likert scale ranging from 1-5. A higher score indicates greater health-related quality of life.	Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported)
Secondary	Children's Global Assessment Scale (CGAS)	The CGAS is a single item clinician rated 1-100 scale that integrates psychological, social, and academic functioning in children as a measure of psychiatric disturbance. Higher values represent a better outcome.	Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (clinician reported)
Secondary	The Clinical Global Impressions -Severity and Improvement scales (CGI-S; CGI-I)	The CGI-S and CGI-I are clinician rated 1-item scales ranging from 1-7 where higher ratings indicate greater symptom severity (CGI-S), and greater symptom improvement (CGI-I), respectively.	Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (clinician reported)