Back to resultsDeveloping Text-based Support for Parents of Adolescents After an Emergency Department Visit
Primary Purpose
Suicide
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
A-F texting component
P-F texting component
Sponsored by
About this trial
This is an interventional supportive care trial for Suicide focused on measuring Emergency Department
Eligibility 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
Sites / Locations
- The University of Michigan
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
Control (standard care)
A-F texting component
A-F texting plus P-F texting component
Arm Description
The A-F texting component will include content consistent with best-practice recommendations for parents to buffer youth against suicide risk.
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.
Outcomes
Primary Outcome Measures
Percentage of eligible participants who agree to participate in the study
Percentage of participants who complete follow-up assessments
Percentages of participants randomized to the intervention who remain active (i.e. do not request to stop receiving messages) (Texting arms only)
Participating parents' satisfaction with the intervention
Measured using the Modified Client Satisfaction Questionnaire (CSQ) with a range of 1-4 with higher scores indicating greater satisfaction
Secondary Outcome Measures
Full Information
NCT ID
NCT05058664
First Posted
September 16, 2021
Last Updated
October 25, 2022
Sponsor
University of Michigan
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT05058664
Brief Title
Developing Text-based Support for Parents of Adolescents After an Emergency Department Visit
Official Title
Developing Text-based Support for Parents of Suicidal Adolescents After Emergency Department Visits: A Multi-component Intervention Pilot
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 8, 2021 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide
Keywords
Emergency Department
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
There are 3 arms: control and 2 intervention arms. One of the intervention arms includes further twice daily (within-person) randomizations.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control (standard care)
Arm Type
No Intervention
Arm Title
A-F texting component
Arm Type
Experimental
Arm Description
The A-F texting component will include content consistent with best-practice recommendations for parents to buffer youth against suicide risk.
Arm Title
A-F texting plus P-F texting component
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
A-F texting component
Intervention Description
Over the course of the 6-week intervention parents in the A-F condition will receive 1 message each day.
Intervention Type
Behavioral
Intervention Name(s)
P-F texting component
Intervention Description
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)
Primary Outcome Measure Information:
Title
Percentage of eligible participants who agree to participate in the study
Time Frame
Baseline
Title
Percentage of participants who complete follow-up assessments
Time Frame
Up to 12 weeks
Title
Percentages of participants randomized to the intervention who remain active (i.e. do not request to stop receiving messages) (Texting arms only)
Time Frame
Up to 12 weeks
Title
Participating parents' satisfaction with the intervention
Description
Measured using the Modified Client Satisfaction Questionnaire (CSQ) with a range of 1-4 with higher scores indicating greater satisfaction
Time Frame
Up to 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ewa Czyz
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Developing Text-based Support for Parents of Adolescents After an Emergency Department Visit
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