Advancing Suicide Intervention Strategies for Teens (ASSIST): study protocol for a multisite randomised controlled trial.
Molly Adrian, Elizabeth McCauley, Robert Gallop...
https://pubmed.ncbi.nlm.nih.gov/38086585/Actively Recruiting
Led by Seattle Children's Hospital · Updated on 2025-11-14
306
Participants Needed
2
Research Sites
N/A
Total Duration
Researchers are evaluating strategies to improve the management of suicide risk in adolescents aged 11 to 17 who are experiencing suicidal thoughts or behaviors. The study aims to compare two specific behavioral interventions, Safety Planning Intervention with follow-up SPI and Collaborative Assessment and Management of Suicidality CAMS, against usual care. The goal is to develop evidence supporting treatments that can be widely adopted, maintained with quality, and have lasting impact on preventing suicidal events. The study involves three groups one receiving usual care which includes crisis prevention planning and referrals one receiving SPI, a brief intervention with weekly follow-ups between 4 and 8 sessions focusing on recognizing suicidal crisis triggers and creating personalized safety plans and one receiving CAMS, a problem-focused treatment targeting the reasons behind suicidal thoughts with 4 to 8 sessions. Both SPI and CAMS are structured interventions designed to engage adolescents and clinicians in collaborative treatment planning. Participants and their parents will be assessed at baseline and multiple follow-up points over 12 months, including 2 weeks, 1 month, 2 months, 6 months, and 12 months. Assessments will cover demographics, suicidal behaviors and thoughts, self-injury, treatment use, risk perception, sleep, family relationships, and social experiences. The primary outcome is the occurrence of suicidal events at 12 months. Safety and treatment integrity will be monitored throughout, with the study conducted under the oversight of Seattle Childrens Hospital.
CONDITIONS
Advancing Suicide Intervention Strategies for Teens During High Risk Periods
M
Molly Adrian
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Seattle Children's Hospital
Lead Sponsor
Nationwide Children's Hospital
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | SPI+ | CAMS | Enhanced Usual Care |
|---|---|---|---|
| What it is | A structured behavioral intervention that includes a six‑step crisis response plan with weekly follow‑up sessions (4 to 8 sessions) | A clinician‑led behavioral intervention targeting patient‑defined drivers of suicidality with 4 to 8 sessions | Care that would typically follow acute care admission for suicidality |
| Role in study | One of two investigational behavioral treatments being tested | One of two investigational behavioral treatments being tested | Represents the typical post‑acute follow‑up care for adolescents after suicidal crisis |
| Purpose | To develop a personalized safety response plan and support during high‑risk periods | To collaboratively assess and address the underlying drivers of suicidal thoughts and behaviors | To provide the existing standard follow‑up care after acute suicidal crisis |
| How it is performed | Up to eight weekly individual sessions covering six structured steps | Between four and eight clinician‑led treatment sessions | Varies according to usual clinical practice after discharge |
| Evidence status | Not yet established; effectiveness under study | Not yet established; being evaluated in trial | Clinical outcomes based on standard care practices |
| Important risks | No established safety profile yet | No established safety profile yet | Based on standard clinical follow‑up; known safety depends on care providers |
| Important limitations | Effectiveness and safety not yet known | Effectiveness and safety not yet known | May vary widely across settings; not standardized in trial |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 4 to 8 weeks
Participants receive one of three interventions: Safety Planning Intervention+ (SPI+), Collaborative Assessment and Management of Suicidality (CAMS), or Treatment As Usual. SPI+ and CAMS involve weekly behavioral therapy sessions, with 4 to 8 sessions aimed at reducing suicidal crises. Treatment As Usual follows typical acute care protocols without alteration by the study.
Weekly visits for 4 to 8 weeks
Duration - Up to 12 months
Participants and their parents complete study assessments to monitor suicidal ideation, suicide attempts, and other behavioral and social factors at multiple timepoints after treatment.
Visits at 2 weeks, 1 month, 2 months, 6 months, and 12 months after treatment starts
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Molly Adrian, Elizabeth McCauley, Robert Gallop...
https://pubmed.ncbi.nlm.nih.gov/38086585/Seattle Children's Hospital
Lead Sponsor
Nationwide Children's Hospital
Collaborating Sponsor