Advancing Suicide Intervention Strategies for Teens During High Risk Periods (ASSIST)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT05078970 |
|
Recruitment Status :
Recruiting
First Posted : October 15, 2021
Last Update Posted : May 18, 2023
|
Sponsor:
Seattle Children's Hospital
Collaborator:
Nationwide Children's Hospital
Information provided by (Responsible Party):
Molly Adrian, Seattle Children's Hospital
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Brief Summary:
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Suicide Attempts Suicidal Ideation Suicide and Self-harm Suicide Threat | Behavioral: Safety Planning Intervention+ (SPI+) Behavioral: Collaborative Assessment and Management of Suicidality (CAMS) Behavioral: Treatment As Usual | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 306 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Participants will be randomized in a 1:1:1 ratio to
|
| Masking: | Single (Outcomes Assessor) |
| Masking Description: | Assessors will be blind to treatment assignment. It is not possible for clinicians or families to be blind to treatment procedures in psychotherapy since orientation to the model of care is part of psychotherapy. |
| Primary Purpose: | Treatment |
| Official Title: | Advancing Suicide Intervention Strategies for Teens During High Risk Periods |
| Actual Study Start Date : | August 11, 2022 |
| Estimated Primary Completion Date : | August 1, 2026 |
| Estimated Study Completion Date : | August 1, 2026 |
| Arm | Intervention/treatment |
|---|---|
|
Active Comparator: Treatment As Usual (TAU)
Participants in this group will be studied as they proceed through treatment in the acute care setting and follow the intervention plan laid out in the discharge summary, per usual protocols at each facility. In both settings, the elements of typical care include crisis prevention planning, which outlines potential triggers, skills to use, and people and places to call in crisis, as well as referral to ongoing behavioral health treatment. We will not alter usual care but track recommendations, contacts and care through questionnaires the family completes as well as medical record review in order to understand the impact of the experimental conditions in relation to typical services.
|
Behavioral: Treatment As Usual
This assigned condition tracks the care received in typical circumstances.
Other Name: Usual Care |
|
Active Comparator: 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, 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.
|
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, 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. |
|
Active Comparator: 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 a 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.
|
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 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. |
Primary Outcome Measures :
- 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 Outcome Measures :
- Suicide attempts [ Time Frame: Suicide attempts at 12 months ]Self injurious behavior with intent to die as measured by the C-SSRS
- 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.
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 11 Years to 17 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05078970
Contacts
| Contact: Molly Adrian | 206-987-7183 | molly.adrian@seattlechildrens.org |
Locations
| United States, Ohio | |
| Nationwide Children's | Recruiting |
| Columbus, Ohio, United States, 43205 | |
| Contact: Emily Hart emily.hart@nationwidechildrens.org | |
| Principal Investigator: Jeff Bridge | |
| United States, Washington | |
| Seattle Children's | Recruiting |
| Seattle, Washington, United States, 98115 | |
| Contact: Molly Adrian molly.adrian@seattlechildrens.org | |
| Contact: Assist Study assist@seattlechildrens.org | |
| Principal Investigator: Molly Adrian | |
Sponsors and Collaborators
Seattle Children's Hospital
Nationwide Children's Hospital
Investigators
| Principal Investigator: | Molly Adrian | Seattle Childrens |
| Responsible Party: | Molly Adrian, Associate Professor, Seattle Children's Hospital |
| ClinicalTrials.gov Identifier: | NCT05078970 |
| Other Study ID Numbers: |
1R01MH123442 ( U.S. NIH Grant/Contract ) |
| First Posted: | October 15, 2021 Key Record Dates |
| Last Update Posted: | May 18, 2023 |
| Last Verified: | May 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Data will be submitted to the National Institute of Mental Health Data Repository |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) |
| Time Frame: | Data will be available in the NIMH NDA 1 year from study completion. |
| Access Criteria: | NIMH NDA access criteria applies. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
|
Suicide Suicidal Ideation Suicide, Attempted Self-Injurious Behavior Behavioral Symptoms |