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Adaptive Intervention for Adolescents Following Inpatient Psychiatric Care

Primary Purpose

Suicide, Suicide, Attempted, Suicidal Ideation

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MI- Safety Plan
Texts messages
Monitoring
Portal follow-up
Booster call
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicide focused on measuring Adaptive Intervention, Technology-based interventions, In-patient, Sequential, Multiple Assignment, Randomized Trial (SMART), Adolescent, Safety planning, Mobile technology

Eligibility Criteria

13 Years - 17 Years (Child)All SexesDoes not accept 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.

Sites / Locations

  • University of Michigan's (Child and Adolescent Psychiatric Inpatient Program)Recruiting
  • Henry Ford Health System (Kingwood Hospital)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

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

MI-SP + monitoring (Sequence D)

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

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

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

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

Arm 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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

The Columbia-Suicide Severity Rating Scale (C-SSRS)
This is a semi-structured interview and will be used to assess suicidal behavior (actual, interrupted, aborted suicide attempts).

Secondary Outcome Measures

C-SSRS will be used to assess the secondary outcome of time-to-suicidal behavior within 6 months of discharge
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)
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).

Full Information

First Posted
March 7, 2022
Last Updated
December 2, 2022
Sponsor
University of Michigan
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT05282225
Brief Title
Adaptive Intervention for Adolescents Following Inpatient Psychiatric Care
Official Title
Adaptive Intervention to Prevent Adolescent Suicidal Behavior Following Psychiatric Hospitalization
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 7, 2022 (Actual)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide, Suicide, Attempted, Suicidal Ideation, Self Harm
Keywords
Adaptive Intervention, Technology-based interventions, In-patient, Sequential, Multiple Assignment, Randomized Trial (SMART), Adolescent, Safety planning, Mobile technology

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Sequential, multiple assignment, randomized trial (SMART) design of an adjunctive, multi-component intervention.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MI-SP +supportive Texts + monitoring (Sequence A)
Arm Type
Experimental
Arm 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.
Arm Title
MI-SP + monitoring (Sequence D)
Arm Type
Experimental
Arm 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.
Arm Title
MI-SP + supportive Texts + monitoring + portal follow-up for non-responders (Sequence B).
Arm Type
Experimental
Arm 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.
Arm Title
MI-SP + supportive Texts + monitoring + booster call for non-responders (Sequence C)
Arm Type
Experimental
Arm 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.
Arm Title
MI-SP + monitoring + portal follow-up for non-responders (Sequence E)
Arm Type
Experimental
Arm 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.
Arm Title
MI-SP + monitoring + booster call for non-responders (Sequence F)
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
MI- Safety Plan
Intervention Description
The MI-enhanced safety plan (MI-SP) component is delivered during hospitalization and includes an individual and family meetings. The goal of the individual meeting with the adolescent is to develop an individualized safety plan for use during a suicidal crisis. This "best practices" approach of safety planning is augmented with Motivational Interviewing (MI) as a core strategy to explicitly elicit adolescents' motivation and commitment to behavior change (i.e. use safety plan; adaptive coping), address barriers or ambivalence, and strengthen self-efficacy. The focus of the family meeting, which is similarly guided by MI, is to prepare parents/guardians, with input from the adolescent, for how they may support the adolescent in implementing the individualized safety plan after discharge and on strengthening parents' commitment and self-efficacy
Intervention Type
Behavioral
Intervention Name(s)
Texts messages
Intervention Description
For participants randomized to receive supportive text messages (Texts), text messages will be sent daily for 4 weeks. The messages will be tailored to encourage use of individualized coping strategies identified as part of safety planning at hospitalization and will include additional adaptive coping tools and resources. The text message content and tone will be consistent with principles of MI.
Intervention Type
Behavioral
Intervention Name(s)
Monitoring
Intervention Description
Adolescent participants will complete daily surveys for 4 weeks (including assessment of suicidal ideation, behavior, and other relevant risk and protective factors) and these will be monitored daily to identify presence of heightened suicidal ideation and presence of suicidal behavior. In addition, daily surveys will be used to determine if adolescents are sufficient responders to Phase 1 intervention.
Intervention Type
Behavioral
Intervention Name(s)
Portal follow-up
Intervention Description
This will be part of Phase 2. The portal follow-up will similarly address content offered in the booster call. For the adolescent, the focus will be on revisiting and adjusting the safety plan, addressing barriers to safety plan adherence, as well as enhancing motivation and self-efficacy to use healthy coping. For the parent, portal communication will focus on revisiting safety recommendations provided as part of MI-SP, addressing barriers in implementing safety recommendations and in supporting the adolescent's safety plan use, as well as enhancing parents' motivation and self-efficacy in these areas. The portal will enable additional asynchronous contacts up to 3 weeks to provide added support and problem solving, based on identified barriers and concerns, to promote post-discharge behavior change. Counselors will initiate approximately 6 contacts with adolescents and, separately, with parents over 3 weeks as soon as non-response is detected.
Intervention Type
Behavioral
Intervention Name(s)
Booster call
Intervention Description
The focus of the post-discharge booster phone call with adolescent and with parent, each conducted separately, is to further adjust the safety plan to better meet post-discharge needs, to further enhance adolescents' motivation and commitment to use coping strategies, and to further support adolescents' and parents' self-efficacy to manage suicidal crises.
Primary Outcome Measure Information:
Title
The Columbia-Suicide Severity Rating Scale (C-SSRS)
Description
This is a semi-structured interview and will be used to assess suicidal behavior (actual, interrupted, aborted suicide attempts).
Time Frame
up to 3 months after discharge
Secondary Outcome Measure Information:
Title
C-SSRS will be used to assess the secondary outcome of time-to-suicidal behavior within 6 months of discharge
Description
The Columbia-Suicide Severity Rating Scale (C-SSRS), a semi-structured interview, will be used to assess suicidal behavior (actual, interrupted, aborted suicide attempts).
Time Frame
up to 6 months
Title
Suicidal Ideation Questionnaire-Junior (SIQ-JR)
Description
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).
Time Frame
up to 6 months after discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ewa Czyz
Phone
734-764-9466
Email
ewac@umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ewa Czyz
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan's (Child and Adolescent Psychiatric Inpatient Program)
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Renaud, LMSW, MSW
Email
lfrenaud@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Ewa Czyz, Ph.D.
Email
ewac@umich.edu
First Name & Middle Initial & Last Name & Degree
Ewa Czyz, PhD
Facility Name
Henry Ford Health System (Kingwood Hospital)
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jordan Braciszewski, PhD
Phone
313-874-6248
First Name & Middle Initial & Last Name & Degree
Celeste Zabel, MPH
Phone
313-556-7853
First Name & Middle Initial & Last Name & Degree
Jordan Braciszewski, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Adaptive Intervention for Adolescents Following Inpatient Psychiatric Care

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