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Recruiting NCT05078970

Advancing Suicide Intervention Strategies for Teens During High Risk Periods

No phase Interventional Suicide Attempts Suicidal Ideation Suicide and Self-harm Suicide Threat

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Safety Planning Intervention+ (SPI+), Collaborative Assessment and Management of Suicidality (CAMS), Treatment As Usual.
Who it may be relevant to
Registry conditions: Suicide Attempts, Suicidal Ideation, Suicide and Self-harm, Suicide Threat. Basic parameters: 11 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

To inform the effective management of adolescent suicide risk by evaluating promising treatments and developing the evidence-base for interventions that are well suited for widespread adoption, sustained quality, and impact.

Detailed description

The current study aims to evaluate Safety Planning Intervention with follow-up (SPI+), Collaborative Assessment and Management of Suicidality (CAMS) and usual care. Adolescents, parents, and clinicians will participate in the project to advance to following Research Aims: 1) Assess the comparative effectiveness of CAMS and SPI+ compared to usual care, 2) Evaluate the mechanism of change accounting for the therapeutic effects of the interventions 3) Identify moderators of treatment effects. Participants and their parents will receive study assessments at baseline, 2-week, 1-month, 2-month, 6-month, and 12-month timepoints. Study assessments will ask about participant demographics (sample characterization), suicide attempts, suicidal ideation, non-suicidal self-injury, service utilization, self-assessed risk, treatment integrity, sleep, family cohesion, and social experiences. Youth participants and their legal guardian both consent to participate in the research procedures.

Interventions

  • Behavioral Safety Planning Intervention+ (SPI+)
    SPI is focused on how the risk of suicidal crisis waxes and wanes over time. At times of heightened risk, a pre-specified and individualized plan targets the internal warning signs that become the cue to use the safety plan. SPI+ strategies focus on patient's narrative of the suicidal crisis and identifying solutions that are antithetical to progressing in a suicidal crisis. The brief structured intervention is conducted in six key steps. Youth in this condition will be offered weekly follow-up,
  • Behavioral Collaborative Assessment and Management of Suicidality (CAMS)
    CAMS strategies focus on collaborative deconstruction and treatment of the patient-defined drivers- the problems that make suicide compelling to the patient- and utilizes these problem-focused treatment sessions to treat the drivers as directly related to wish to die. Participants will be assigned to CAMS for a minimum of 4 sessions and maximum of eight sessions. This time frame, based on initial data from our pilot work with adolescents and emerging adults (18-25), suggests that a subset of par
  • Behavioral Treatment As Usual
    This assigned condition tracks the care received in typical circumstances.

Primary outcome measures

  • Suicidal events [Time frame: Suicidal events at 12 months]
Secondary outcome measures (2)
  • Suicide attempts [Time frame: Suicide attempts at 12 months]
  • Suicidal Ideation [Time frame: Change in score from baseline to 12 months]

Eligibility criteria

Inclusion criteria

  • Provision of signed and dated informed consent form
  • Youth, aged 11-17
  • Endorse suicidal ideation and/or behavior
  • Admitted to acute care (emergency, inpatient medical or inpatient psychiatric) due to suicidality

Exclusion criteria

  • Presence of psychosis, intellectual disability, autism spectrum disorder, eating disorder with unstable vitals
  • Limited English proficiency that would interfere with the ability to complete study assessments

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 2 centers
  • Nationwide Children's — Columbus
  • Seattle Children's — Seattle

Publications

  • Adrian M, McCauley E, Gallop R, Stevens J, Jobes DA, Crumlish J, Stanley B, Brown GK, Green KL, Hughes JL, Bridge JA. Advancing Suicide Intervention Strategies for Teens (ASSIST): study protocol for a multisite randomised controlled trial. BMJ Open. 2023 Dec 12;13(12):e074116. doi: 10.1136/bmjopen-2023-074116. PMID 38086585

Identifiers

NCT: NCT05078970 · 1R01MH123442

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗