Adaptive Intervention for Adolescents Following Inpatient Psychiatric Care
- Conditions
- Suicide, AttemptedSuicideSuicidal IdeationSelf Harm
- Interventions
- Behavioral: MI- Safety PlanBehavioral: MonitoringBehavioral: Texts messagesBehavioral: Portal follow-upBehavioral: Booster call
- Registration Number
- NCT05282225
- Lead Sponsor
- University of Michigan
- Brief Summary
This study is being completed to examine different combinations of technology-augmented strategies to identify an effective Adaptive intervention (AI) addressing post-discharge suicide risk with high implementation potential.
- Detailed Description
The proposed study is a sequential multiple assignment randomized trial (SMART) to identify an effective adaptive intervention (AI) for adolescents at elevated suicide risk transitioning from acute psychiatric care. Participants will be initially randomized to Motivational Interview (MI)-enhanced safety planning (MI-SP) or to MI-SP with supportive text messages delivered for four weeks after discharge (Texts) (Phase 1 intervention). Adolescents who are classified as Phase 1 non-responders at the end of the first or at the end of the second week post-discharge, based on their responses to daily surveys , will be re-randomized to either added booster call or portal follow-up (Phase 2 intervention). Those classified as Phase 1 responders at the end of the second week post discharge will continue with the initially assigned intervention options. Thus, participants will receive one of six treatment sequences resulting from the different intervention components or their combinations. These six treatment sequences, in turn, will form four AIs.
The study team anticipates that AIs that begin with MI-SP plus text-based support will have:
* lower odds of suicidal behavior 3 months post discharge
* longer time to suicidal behavior over the 6 month follow-up
* less severe suicidal ideation over the 6-month follow-up
Additionally, the study team anticipates that the AI that begins with MI-SP + Texts followed by portal follow-up for non-responders will lead to:
* lowest odds of suicidal behavior within 3 months
* longest time to suicidal behavior over the 6 month follow up
* least severe ideation over the 6-month follow-up
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
- A suicide attempt in the last month or (2) past-week suicidal ideation (based on the Columbia-Suicide Severity Rating Scale (C-SSRS). In the absence of C-SSRS ratings in the chart, attending physician indication in the chart of the presence of suicidal ideation within the last week or the presence of a suicide attempt in the last month will be used.
- Adolescent presenting with severe cognitive impairment or with altered mental status (acute psychosis or acute manic state)
- Transfer to medical unit or residential placement
- No availability of a legal guardian
- Adolescent not owning a cell phone.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description MI-SP + monitoring (Sequence D) Monitoring Sequencing of intervention components (Phase 1 and Phase 2) resulting in Sequence or Group D: Participants will receive the in-person MI-enhanced safety plan (MI-SP) during hospitalization followed by 4 weeks of monitoring post discharge. MI-SP + supportive Texts + monitoring + booster call for non-responders (Sequence C) MI- Safety Plan Sequencing of intervention components (Phase 1 and Phase 2) resulting in Sequence or Group C: Participants will receive the in-person MI-enhanced safety plan (MI-SP) during hospitalization followed by 4 weeks of supportive Texts and monitoring post discharge in addition to the booster call for non-responders. MI-SP +supportive Texts + monitoring (Sequence A) Texts messages Sequencing of intervention components (Phase 1 and Phase 2) resulting in Sequence or Group A: Participants will receive the in-person MI-enhanced safety plan (MI-SP) during hospitalization followed by 4 weeks of supportive Texts and monitoring post discharge. MI-SP +supportive Texts + monitoring (Sequence A) Monitoring Sequencing of intervention components (Phase 1 and Phase 2) resulting in Sequence or Group A: Participants will receive the in-person MI-enhanced safety plan (MI-SP) during hospitalization followed by 4 weeks of supportive Texts and monitoring post discharge. MI-SP +supportive Texts + monitoring (Sequence A) MI- Safety Plan Sequencing of intervention components (Phase 1 and Phase 2) resulting in Sequence or Group A: Participants will receive the in-person MI-enhanced safety plan (MI-SP) during hospitalization followed by 4 weeks of supportive Texts and monitoring post discharge. MI-SP + supportive Texts + monitoring + portal follow-up for non-responders (Sequence B). Monitoring Sequencing of intervention components (Phase 1 and Phase 2) resulting in Sequence or Group B: Participants will receive the in-person MI-enhanced safety plan (MI-SP) during hospitalization followed by 4 weeks of supportive Texts and monitoring post discharge in addition to the portal follow-up for non-responders. MI-SP + supportive Texts + monitoring + booster call for non-responders (Sequence C) Texts messages Sequencing of intervention components (Phase 1 and Phase 2) resulting in Sequence or Group C: Participants will receive the in-person MI-enhanced safety plan (MI-SP) during hospitalization followed by 4 weeks of supportive Texts and monitoring post discharge in addition to the booster call for non-responders. MI-SP + supportive Texts + monitoring + portal follow-up for non-responders (Sequence B). MI- Safety Plan Sequencing of intervention components (Phase 1 and Phase 2) resulting in Sequence or Group B: Participants will receive the in-person MI-enhanced safety plan (MI-SP) during hospitalization followed by 4 weeks of supportive Texts and monitoring post discharge in addition to the portal follow-up for non-responders. MI-SP + supportive Texts + monitoring + portal follow-up for non-responders (Sequence B). Texts messages Sequencing of intervention components (Phase 1 and Phase 2) resulting in Sequence or Group B: Participants will receive the in-person MI-enhanced safety plan (MI-SP) during hospitalization followed by 4 weeks of supportive Texts and monitoring post discharge in addition to the portal follow-up for non-responders. MI-SP + supportive Texts + monitoring + portal follow-up for non-responders (Sequence B). Portal follow-up Sequencing of intervention components (Phase 1 and Phase 2) resulting in Sequence or Group B: Participants will receive the in-person MI-enhanced safety plan (MI-SP) during hospitalization followed by 4 weeks of supportive Texts and monitoring post discharge in addition to the portal follow-up for non-responders. MI-SP + monitoring + portal follow-up for non-responders (Sequence E) Monitoring Sequencing of intervention components (Phase 1 and Phase 2) resulting in Sequence or Group E: Participants will receive the in-person MI-enhanced safety plan (MI-SP) during hospitalization followed by 4 weeks of monitoring post discharge in addition to the portal follow-up for non-responders. MI-SP + monitoring (Sequence D) MI- Safety Plan Sequencing of intervention components (Phase 1 and Phase 2) resulting in Sequence or Group D: Participants will receive the in-person MI-enhanced safety plan (MI-SP) during hospitalization followed by 4 weeks of monitoring post discharge. MI-SP + supportive Texts + monitoring + booster call for non-responders (Sequence C) Booster call Sequencing of intervention components (Phase 1 and Phase 2) resulting in Sequence or Group C: Participants will receive the in-person MI-enhanced safety plan (MI-SP) during hospitalization followed by 4 weeks of supportive Texts and monitoring post discharge in addition to the booster call for non-responders. MI-SP + supportive Texts + monitoring + booster call for non-responders (Sequence C) Monitoring Sequencing of intervention components (Phase 1 and Phase 2) resulting in Sequence or Group C: Participants will receive the in-person MI-enhanced safety plan (MI-SP) during hospitalization followed by 4 weeks of supportive Texts and monitoring post discharge in addition to the booster call for non-responders. MI-SP + monitoring + booster call for non-responders (Sequence F) Monitoring Sequencing of intervention components (Phase 1 and Phase 2) resulting in Sequence or Group F: Participants will receive the in-person MI-enhanced safety plan (MI-SP) during hospitalization followed by 4 weeks of monitoring post discharge in addition to the booster call for non-responders. MI-SP + monitoring + portal follow-up for non-responders (Sequence E) MI- Safety Plan Sequencing of intervention components (Phase 1 and Phase 2) resulting in Sequence or Group E: Participants will receive the in-person MI-enhanced safety plan (MI-SP) during hospitalization followed by 4 weeks of monitoring post discharge in addition to the portal follow-up for non-responders. MI-SP + monitoring + portal follow-up for non-responders (Sequence E) Portal follow-up Sequencing of intervention components (Phase 1 and Phase 2) resulting in Sequence or Group E: Participants will receive the in-person MI-enhanced safety plan (MI-SP) during hospitalization followed by 4 weeks of monitoring post discharge in addition to the portal follow-up for non-responders. MI-SP + monitoring + booster call for non-responders (Sequence F) Booster call Sequencing of intervention components (Phase 1 and Phase 2) resulting in Sequence or Group F: Participants will receive the in-person MI-enhanced safety plan (MI-SP) during hospitalization followed by 4 weeks of monitoring post discharge in addition to the booster call for non-responders. MI-SP + monitoring + booster call for non-responders (Sequence F) MI- Safety Plan Sequencing of intervention components (Phase 1 and Phase 2) resulting in Sequence or Group F: Participants will receive the in-person MI-enhanced safety plan (MI-SP) during hospitalization followed by 4 weeks of monitoring post discharge in addition to the booster call for non-responders.
- Primary Outcome Measures
Name Time Method The Columbia-Suicide Severity Rating Scale (C-SSRS) up to 3 months after discharge This is a semi-structured interview and will be used to assess suicidal behavior (actual, interrupted, aborted suicide attempts).
- Secondary Outcome Measures
Name Time Method C-SSRS will be used to assess the secondary outcome of time-to-suicidal behavior within 6 months of discharge up to 6 months The Columbia-Suicide Severity Rating Scale (C-SSRS), a semi-structured interview, will be used to assess suicidal behavior (actual, interrupted, aborted suicide attempts).
Suicidal Ideation Questionnaire-Junior (SIQ-JR) up to 6 months after discharge Suicide ideation will be measured using the Suicidal Ideation Questionnaire (SIQ-JR), a 15-item measure of adolescents' distress and suicidal intent. Scale scores range from 0 to 90, with higher scores meaning a worse outcome (i.e., greater suicide ideation).
Trial Locations
- Locations (2)
University of Michigan's (Child and Adolescent Psychiatric Inpatient Program)
🇺🇸Ann Arbor, Michigan, United States
Henry Ford Health System (Kingwood Hospital)
🇺🇸Detroit, Michigan, United States