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Clinical Trials/NCT05058664
NCT05058664CompletedNot Applicable

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

University of Michigan1 site in 1 country240 target enrollmentStarted: November 8, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
240
Locations
1
Primary Endpoint
Participant Dyads Who Completed Follow-up Assessments

Study Overview

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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
13 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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

Arms & Interventions

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.

Intervention: A-F texting component (Behavioral)

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.

Intervention: A-F texting component (Behavioral)

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.

Intervention: P-F texting component (Behavioral)

Outcomes

Primary Outcomes

Participant Dyads Who Completed Follow-up Assessments

Time Frame: Up to 12 weeks

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.

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

Time Frame: Up to 6 weeks

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).

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

Time Frame: Up to 6 weeks

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

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

Time Frame: At the time of youth Emergency Department visit

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

Number of and Reasons for Active Withdrawals

Time Frame: Up to 12 weeks

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ewa Czyz

Assistant Professor, Department of Psychiatry, University of Michigan

University of Michigan

Study Sites (1)

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