Adaptive Intervention for Adolescents Following Inpatient Psychiatric Care

University of Michigan

Status: Active, not recruiting

Conditions: Suicide, Attempted; Suicidal Ideation; Self Harm; Suicide

Treatments: Behavioral: Portal follow-up; Behavioral: Texts messages; Behavioral: Monitoring; Behavioral: MI- Safety Plan; Behavioral: Booster call

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05282225

1R01MH126871 (U.S. NIH Grant/Contract)

HUM00204329

Details and patient eligibility

About

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.

Full 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

Enrollment: 300 estimated patients

Sex: All

Ages: 13 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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300 participants in 6 patient groups

MI-SP +supportive Texts + monitoring (Sequence A)

Experimental group

Description:

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.

Treatment:

Behavioral: MI- Safety Plan

Behavioral: Monitoring

Behavioral: Texts messages

MI-SP + monitoring (Sequence D)

Experimental group

Description:

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.

Treatment:

Behavioral: MI- Safety Plan

Behavioral: Monitoring

MI-SP + supportive Texts + monitoring + portal follow-up for non-responders (Sequence B).

Experimental group

Description:

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.

Treatment:

Behavioral: MI- Safety Plan

Behavioral: Monitoring

Behavioral: Texts messages

Behavioral: Portal follow-up

MI-SP + supportive Texts + monitoring + booster call for non-responders (Sequence C)

Experimental group

Description:

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.

Treatment:

Behavioral: Booster call

Behavioral: MI- Safety Plan

Behavioral: Monitoring

Behavioral: Texts messages

MI-SP + monitoring + portal follow-up for non-responders (Sequence E)

Experimental group

Description:

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.

Treatment:

Behavioral: MI- Safety Plan

Behavioral: Monitoring

Behavioral: Portal follow-up

MI-SP + monitoring + booster call for non-responders (Sequence F)

Experimental group

Description:

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.

Treatment:

Behavioral: Booster call

Behavioral: MI- Safety Plan

Behavioral: Monitoring