Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03838198
Other study ID # HUM00129173
Secondary ID 1K23MH113776-01
Status Completed
Phase N/A
First received
Last updated
Start date March 14, 2019
Est. completion date April 7, 2020

Study information

Verified date May 2021
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To inform the development of a technology-augmented adaptive intervention for adolescents at risk for suicide, the goal of this study is to conduct a Sequential, Multiple Assignment, Randomized Trial (SMART) pilot of a Motivational Interview (MI)-enhanced safety planning intervention (MI-SafeCope). Findings from this study will provide the groundwork for the construction of a technology-augmented adaptive intervention that could lead to a reduction in suicidal behaviors and related events during the high-risk post-discharge period-an important suicide prevention target.


Recruitment information / eligibility

Status Completed
Enrollment 82
Est. completion date April 7, 2020
Est. primary completion date April 7, 2020
Accepts healthy volunteers No
Gender All
Age group 13 Years to 17 Years
Eligibility Inclusion Criteria: - Suicide attempt (previous month), and/or - Suicidal ideation (previous week) Exclusion Criteria: - Severe cognitive impairment or altered mental status (psychosis, manic state) - Transfer to medical unit or residential placement - No availability of a legal guardian - No cell phone with text messaging capability

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
MI-Enhanced Safety Plan at Hospitalization (1st Component)
The MI-enhanced safety plan intervention 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.
MI-Enhanced Text Boosters (2nd Component)
For participants randomized to receive text boosters, booster 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.
MI-Enhanced Booster Call (3rd Component)
The focus of the post-discharge booster phone call with adolescent and with parent, each conducted separately, will be to 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.

Locations

Country Name City State
United States University of Michigan Ann Arbor Michigan

Sponsors (2)

Lead Sponsor Collaborator
University of Michigan National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Eligible Participants Recruited to the Study Eligible participants were candidates for participation based on medical record review who were approached for consent/assent.
The percentage of eligible participants who consented to the study is presented below.
At time of study enrollment, measured following study consent/assent
Primary Percentage of Randomized Participants Who Complete Intervention Components Will be Used to Assess Feasibility and Acceptability Outcome measure is showing percentage of randomized adolescent participants who complete intervention components to assess feasibility and acceptability Following intervention, measured up to 1 month
Primary Percentage of Participants Who Complete Study Assessments Will be Used to Assess Feasibility and Acceptability Percentage of participants who complete study assessments, including daily surveys, one month and three month follow ups are used to assess feasibility and acceptability Following intervention and follow-up assessment, measured up to 3 months
Primary Satisfaction Ratings Will be Used to Assess Acceptability Satisfaction was scored by responses to two questions: How satisfied were you? on a 4 point scale, where 1 means very dissatisfied and 4 means very satisfied and how likely would you be to recommend this program to a friend in similar circumstances, on the same point scale, where 1 means definitely not and 4 means definitely yes Following intervention and follow-up assessment, measured up to 3 months
See also
  Status Clinical Trial Phase
Completed NCT04127292 - Impact of Clinician Virtual Human Interaction Training in Emotional Self-Awareness on Patients Suicidal Ideation and Suicide Crisis Syndrome N/A
Recruiting NCT06079853 - Nurse Suicide: Physiologic Sleep Health Promotion Trial N/A
Recruiting NCT05423483 - Developing an Intervention to Promote Lethal Means Safety in Suicidal Adolescents Phase 2
Completed NCT03272048 - Identifying Effective Approaches to Counseling on Firearm Safety N/A
Completed NCT05514587 - Meaning of Life Questionnaire (MLQ) in Patients Admitted to the Crisis Centre (MSVCAC)
Enrolling by invitation NCT05639426 - Preventing Youth Violence Through Building Equitable Communities N/A
Completed NCT03703128 - Suicide in People Aged 45-60: A Case-control Psychological Autopsy Study
Completed NCT03646903 - Reducing Help-Seeking Stigma in Young Adults at Elevated Suicide Risk N/A
Not yet recruiting NCT06349915 - A Pilot Evaluation of a Digital Peer Support Intervention for Suicidal Adolescents N/A
Not yet recruiting NCT05558332 - Youth Nominated Support Team N/A
Completed NCT02718248 - Ottawa Suicide Prevention in Men Pilot Study N/A
Completed NCT02094898 - Ketamine for Depression and Suicide Risk Phase 2
Completed NCT01360736 - A Brief Intervention to Reduce Suicide Risk in Military Service Members and Veterans - Study 2 (SAFEMIL) N/A
Completed NCT01594138 - Linguistic Characteristics of Suicidal Patients in the Emergency Department N/A
Completed NCT02228044 - Alcohol, Suicide and HIV Prevention for Teens in Mental Health Treatment N/A
Completed NCT00604097 - Preventing Youth Suicide in Primary Care: A Family Model Phase 3
Completed NCT00387855 - An Evaluation of the SOS (Suicide Prevention) Program N/A
Recruiting NCT03519802 - Evaluation of Cognitive Function in a Suicidal Crisis
Completed NCT05580757 - Pharmacists as Gate Keepers in Suicide Prevention: Needs of Pharmacists
Recruiting NCT03030924 - Wearable Suicidal Early Warning System for Adolescents