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

Developing Text-based Support for Parents of Suicidal Adolescents After Emergency Department Visits: A Multi-component Intervention Pilot

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

Study Overview

• Status: Completed
• Conditions: Suicide
• Intervention / Treatment: Behavioral: A-F texting component; Behavioral: P-F texting component

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • The University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Parent eligibility:

Inclusion Criteria:

• Parent of eligible teen

Exclusion Criteria:

• Not owning a cell phone with text messaging capability.

Teen eligibility:

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control (standard care)
Experimental: 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.	Behavioral: A-F texting component; Over the course of the 6-week intervention parents in the A-F condition will receive 1 message each day.
Experimental: 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.	Behavioral: A-F texting component; Over the course of the 6-week intervention parents in the A-F condition will receive 1 message each day.; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Ewa Czyz, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2021
• Primary Completion (Actual): September 26, 2022
• Study Completion (Actual): September 26, 2022

Study Registration Dates

• First Submitted: September 16, 2021
• First Submitted That Met QC Criteria: September 16, 2021
• First Posted (Actual): September 28, 2021

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Emergency Department
• Additional Relevant MeSH Terms: Behavioral Symptoms; Pathologic Processes; Disease Attributes; Self-Injurious Behavior; Emergencies; Suicide
• Other Study ID Numbers: HUM00184110; 1R34MH124767-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No