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

Suicide Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05058664
• Other study ID #: HUM00184110
• Secondary ID: 1R34MH124767-01
• Status: Completed
• Phase: N/A
• Start date: November 8, 2021
• Est. completion date: September 26, 2022

Study information

• Verified date: April 2024
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: September 26, 2022
• Est. primary completion date: September 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Suicide

Intervention

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.
• 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)

Locations

Country	Name	City	State
United States	The 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 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
Primary	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
Primary	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
Primary	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
Primary	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