Developing Text-based Support for Parents of Adolescents After an Emergency Department Visit

NCT ID: NCT05058664

Last Updated: 2024-05-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-08

Study Completion Date

2022-09-26

Brief Summary

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

Detailed Description

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Participants in the trial included 120 youth-parent dyads (120 youths and 120 parents). As the ultimate focus of the intervention is on improving youth outcomes, participant-related descriptives are provided for youth participants, except where noted specifically to be parent-related data.

Conditions

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Suicide

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

There are 3 arms: control and 2 intervention arms. One of the intervention arms includes further twice daily (within-person) randomizations.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control (standard care)

Group Type NO_INTERVENTION

No interventions assigned to this group

A-F texting component

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

Group Type EXPERIMENTAL

A-F texting component

Intervention Type BEHAVIORAL

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

A-F texting plus P-F texting component

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.

Group Type EXPERIMENTAL

A-F texting component

Intervention Type BEHAVIORAL

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

P-F texting component

Intervention Type BEHAVIORAL

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)

Interventions

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A-F texting component

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

Intervention Type BEHAVIORAL

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)

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Parent of eligible teen


* Recent suicidal ideation (within last 2 weeks) and/or suicide attempt within the last month.

Exclusion Criteria

* Not owning a cell phone with text messaging capability.

Teen eligibility:


* 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
Minimum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Ewa Czyz

Assistant Professor, Department of Psychiatry, University of Michigan

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ewa Czyz

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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The University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 40354273 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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1R34MH124767-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM00184110

Identifier Type: -

Identifier Source: org_study_id

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