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NCT Number: NCT05078970

Advancing Suicide Intervention Strategies for Teens During High Risk Periods

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.

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Key information

Conditions

Suicide Attempts Behavior Behavioral Symptoms Self-Injurious Behavior Suicidal Ideation Suicide Suicide Threat Suicide and Self-harm Suicide, Attempted

Age range

11 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nationwide Children's, Columbus, Ohio, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Safety Planning Intervention+ (SPI+)

Behavioral

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, with a minimum of 4 sessions and a maximum of 8 sessions. The goal is to create a crisis response plan to reduce risk when suicidal crises emerge. With adolescents, SPI+ consists of an individual session to elicit crisis narrative and motivation to utilize the safety plan through psychoeducation and follows six steps to achieve the adolescent's goals and return to safety when suicidal urges are high.

Collaborative Assessment and Management of Suicidality (CAMS)

Behavioral

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 participants resolve their STB in six to eight sessions. CAMS is a clinical intervention designed to modify how clinicians engage, assess and plan treatment with suicidal patients.

Treatment as Usual

Behavioral

This assigned condition tracks the care received in typical circumstances.

Other names: Usual Care

Primary outcomes

  1. Suicidal events

    Time frame: Suicidal events at 12 months

    Change the rate of suicidal events as measured by death by suicide, attempted suicide, preparatory acts toward imminent suicidal behavior, or suicidal ideation resulting in a change in treatment plan or emergency evaluation as measured by the C-SSRS.

Secondary outcomes

  1. Suicide attempts

    Time frame: Suicide attempts at 12 months

    Self injurious behavior with intent to die as measured by the C-SSRS

  2. Suicidal Ideation

    Time frame: Change in score from baseline to 12 months

    Severity of suicidal ideation as measured by the total score on the Suicidal Ideation Questionnaire Junior (SIQ-Jr. This 15 item measure is rated on a Likert scale, with scores ranging from 0 to 90, with higher scores reflecting worse outcomes and more severe ideation.

Study contacts

Contact information is provided by the study sponsor or research team.

Molly Adrian

CONTACT

[email protected]

206-987-7183

Sponsors and collaborators

Lead sponsor

Seattle Children's Hospital

Other

Collaborators

  • Nationwide Children's Hospital

Registry information

Acronym: ASSIST

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Oct 15, 2021
Registry last updated
Nov 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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