NCT06660199

Brief Summary

The goal of this study is to determine the effectiveness of an adaptive text-based intervention for parents of adolescents seeking emergency department services for suicide risk concerns.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
420

participants targeted

Target at P75+ for not_applicable

Timeline
25mo left

Started Dec 2025

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress18%
Dec 2025Jul 2028

First Submitted

Initial submission to the registry

October 23, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 28, 2024

Completed
1.1 years until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

December 15, 2025

Status Verified

December 1, 2025

Enrollment Period

2.6 years

First QC Date

October 23, 2024

Last Update Submit

December 12, 2025

Conditions

Keywords

TextSuicidal IdeationSuicide Attempt

Outcome Measures

Primary Outcomes (2)

  • Aim 1 (primary aim): likelihood of suicidal behavior (actual, interrupted, or aborted attempts)

    Suicidal behavior encompasses actual, interrupted, and aborted suicide attempts. Measured with the behavioral subscale of the Columbia-Suicide Severity Rating Scale (C-SSRS),and supplemented with available medical chart data.

    12-week follow-up

  • Aim 2 (secondary aim) severity of parental stress

    Measured with twice daily surveys over the 6-week intervention

    Up to 6 weeks

Secondary Outcomes (4)

  • Aim 1 (primary aim): -time- to- suicidal behavior (actual, interrupted, or aborted suicide attempts

    24-week follow-up

  • Aim 1 (primary aim): time- to- return ED visit

    24-week follow-up.

  • Aim 2 (secondary aim): parental negative affect

    Up to 6 weeks

  • Aim 2 (secondary aim) parental positive affect

    Up to 6 weeks

Study Arms (2)

Standard ED care

NO INTERVENTION

Standard ED care with a text-based intervention

EXPERIMENTAL

This arm incorporates adolescent-centered (A-C) and parent-centered (P-C) texting components Parents in the intervention arm will receive up to 3 text messages per day over six weeks after ED discharge: daily A-C text and up to two P-C messages. The P-C component includes an embedded micro-randomized trial (MRT), and parents will be randomized twice each day over the six-week intervention to either receive or not receive a P-C message.

Behavioral: Text-based intervention

Interventions

Parents randomized to the texting intervention will receive up to 3 messages each day for 6 weeks: The intervention is comprised of adolescent-centered (A-C) texts focusing on parental adherence to recommended suicide prevention strategies to promote adolescents' safety and parent-centered (P-C) texts focused on improving parents' own well-being.

Standard ED care with a text-based intervention

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Adolescent (13-17 years old) who present to Emergency Department (ED) due to (1) last-week suicidal ideation and/or (2) last-month suicide attempt, and their caregiver.

You may not qualify if:

  • Adolescents who are:
  • medically unstable
  • presenting with severe cognitive impairment, altered mental status, severe aggression/agitation
  • presenting without a legal guardian
  • whose parent does not own a cell phone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Hurley Medical Center

Flint, Michigan, 48503, United States

RECRUITING

MeSH Terms

Conditions

SuicideSuicidal IdeationSuicide, Attempted

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • Ewa Czyz, Ph.D.

    University of Michigan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ewa Czyz, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Psychiatry

Study Record Dates

First Submitted

October 23, 2024

First Posted

October 28, 2024

Study Start

December 1, 2025

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2028

Last Updated

December 15, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations