SuicideNCT05058664
Developing Text-based Support for Parents of Adolescents After an Emergency Department Visit
A study testing A-F texting component and P-F texting component in people with Suicide, run by University of Michigan at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Suicide
- What is being tested?
- A-F texting component and P-F texting component
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2021to 26 Sep 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Parent of eligible teen
- Recent suicidal ideation (within last 2 weeks) and/or suicide attempt within the last month.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Michigan
Ann Arbor, Michigan, 48109
About this study
Official title: 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.
Read the 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.
- Conditions
- Suicide
- Being tested
- A-F texting component, P-F texting component
- Keywords
- Emergency Department
- Medical subject headings
- Suicide, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A-F texting componentBehavioural
Over the course of the 6-week intervention parents in the A-F condition will receive 1 message each day.
P-F texting componentBehavioural
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)
| Study group | Role | What they receive |
|---|---|---|
| Control (standard care) | No intervention | Not described |
| 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. Receives: Behavioral: A-F texting component |
| 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. Receives: Behavioral: A-F texting component; Behavioral: P-F texting component |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2021
- Study start8 Nov 2021
- Primary completion26 Sep 2022
- Study completion26 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SuicideStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There are 3 arms: control and 2 intervention arms. One of the intervention arms includes further twice daily (within-person) randomizations.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Ewa Czyz, University of Michigan
- Investigators
- Ewa Czyz, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05058664
- Sponsor's protocol ID
- HUM00184110
- Other IDs
- 1R34MH124767-01
- Status last verified
- Apr 2024
- First submitted
- 16 Sep 2021
- Last updated
- 16 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40354273
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Text-based Support for Parents of Suicidal Adolescents After Emergency Department Visits: A Multi-component Intervention Pilot
- ClinicalTrials.gov ID
- NCT05058664
- Acronym / sponsor ID
- HUM00184110
- Conditions
- Suicide
- Keywords
- Emergency Department
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 8 Nov 2021 (actual)
- Primary completion
- 26 Sep 2022 (actual)
- Study completion
- 26 Sep 2022 (actual)
- First posted
- 28 Sep 2021 (actual)
- Results
- Posted 16 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- There are 3 arms: control and 2 intervention arms. One of the intervention arms includes further twice daily (within-person) randomizations.
| Arm | Type | Receives |
|---|---|---|
| Control (standard care) | No intervention | – |
| A-F texting component | Experimental | Behavioral: A-F texting componentThe 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 | Experimental | Behavioral: A-F texting component, Behavioral: P-F texting componentA-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. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Parent of eligible teen
- Recent suicidal ideation (within last 2 weeks) and/or suicide attempt within the last month.
Key exclusion criteria (5 listed)
- Not owning a cell phone with text messaging capability.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A-F texting componentOver the course of the 6-week intervention parents in the A-F condition will receive 1 message each day. | Behavioural | A-F texting component, A-F texting plus P-F texting component |
| P-F texting componentOver the course of the 6 week intervention, parents will receive between 1-2 messages, depending on randomization (in addition to A-F component messages) | Behavioural | A-F texting plus P-F texting component |
Primary outcome
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.
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.
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).
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).
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40354273Czyz 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ewa Czyz principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A-F texting component and P-F texting component in people with Suicide, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Eligible Youth-Parent Dyads Who Agree to Participate in the Study, (time frame: At the time of youth Emergency Department visit). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05058664, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.