NCT05058664

Brief Summary

The researchers seek to develop a text message intervention for caregivers of adolescents at elevated suicide risk following discharge from emergency department (ED) care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 28, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

November 8, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 26, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 26, 2022

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

May 16, 2024

Completed
Last Updated

May 16, 2024

Status Verified

April 1, 2024

Enrollment Period

11 months

First QC Date

September 16, 2021

Results QC Date

February 2, 2024

Last Update Submit

April 18, 2024

Conditions

Keywords

Emergency Department

Outcome Measures

Primary Outcomes (5)

  • Percentage of Eligible Youth-Parent Dyads Who Agree to Participate in the Study,

    Data represent participant dyads who were eligible and approached about study participation, and who agreed to take part in the study.

    At the time of youth Emergency Department visit

  • Participant Dyads Who Completed Follow-up Assessments

    Data was used to determine retention rate among the participant dyads. We report on follow up completion for both adolescent and caregiver members of the dyad.

    Up to 12 weeks

  • Percentage of Participants Randomized to the Intervention Who Remained Active (Texting Arms Only)

    Results represent parent participants who did not request stopping the intervention (i.e., did not request to stop receiving messages).

    Up to 6 weeks

  • Participating Parents' Satisfaction With the Intervention (Texting Arms Only)

    Measured using the Modified Client Satisfaction Questionnaire (CSQ), which was a 2-question survey. Each question had a range of 1-4. Adult participants were asked to rate both their overall satisfaction (1 meaning not satisfied to 4 meaning highly satisfied), and the likelihood that they would recommend their particular assigned intervention to a friend (1 meaning highly unlikely to 4 meaning highly likely).

    Up to 6 weeks

  • Number of and Reasons for Active Withdrawals

    Parent participant request to withdraw from the study. Study intention was to collect the number of and reasons for withdrawals, but the sole withdrawal did not provide a reason.

    Up to 12 weeks

Study Arms (3)

Control (standard care)

NO INTERVENTION

A-F texting component

EXPERIMENTAL

The A-F texting component will include content consistent with best-practice recommendations for parents to buffer youth against suicide risk.

Behavioral: A-F texting component

A-F texting plus P-F texting component

EXPERIMENTAL

A-F texting plus P-F texting component arm includes the A-F component, as above, and P-F component. The P-F component includes an embedded micro-randomized trial (MRT) involving two daily randomizations to P-F message vs. no message conditions for the duration of the 6-week intervention. Participants who are randomized to this arm will be randomized twice each day (morning and evening) to either receive or not receive the P-F message at each randomization.

Behavioral: A-F texting componentBehavioral: P-F texting component

Interventions

Over the course of the 6-week intervention parents in the A-F condition will receive 1 message each day.

A-F texting componentA-F texting plus P-F texting component

Over the course of the 6 week intervention, parents will receive between 1-2 messages, depending on randomization (in addition to A-F component messages)

A-F texting plus P-F texting component

Eligibility Criteria

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

You may qualify if:

  • Parent of eligible teen

You may not qualify if:

  • Not owning a cell phone with text messaging capability.
  • Teen eligibility:
  • Recent suicidal ideation (within last 2 weeks) and/or suicide attempt within the last month.
  • Youth with severe cognitive impairment or altered mental status (e.g., psychosis, manic state)
  • Youth with severe aggression/agitation
  • No availability of a legal guardian

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

  • Czyz E, Nahum-Shani I, Ewell Foster C, Micol V, Jiang A, Al-Dajani N, Arango A, Walton M, Hong V, Ahamed SI, King C. Building toward a text-based intervention for parents of suicidal adolescents seeking emergency department care: A pilot randomized controlled trial. J Consult Clin Psychol. 2025 May;93(5):382-389. doi: 10.1037/ccp0000950.

MeSH Terms

Conditions

SuicideEmergencies

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehaviorDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Ewa Czyz
Organization
University of Michigan

Study Officials

  • Ewa Czyz

    University of Michigan

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: There are 3 arms: control and 2 intervention arms. One of the intervention arms includes further twice daily (within-person) randomizations.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Department of Psychiatry, University of Michigan

Study Record Dates

First Submitted

September 16, 2021

First Posted

September 28, 2021

Study Start

November 8, 2021

Primary Completion

September 26, 2022

Study Completion

September 26, 2022

Last Updated

May 16, 2024

Results First Posted

May 16, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations