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| ID | Type | Description | Link |
|---|---|---|---|
| 1R34MH124767-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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The researchers seek to develop a text message intervention for caregivers of adolescents at elevated suicide risk following discharge from emergency department (ED) care.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A-F texting component | Behavioral | Over the course of the 6-week intervention parents in the A-F condition will receive 1 message each day. |
|
| 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 |
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Parent eligibility:
Inclusion Criteria:
Exclusion Criteria:
Teen eligibility:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ewa Czyz | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40354273 | Derived | 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. |
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Unless indicated otherwise, the data shown below represent youth participants, as they were the object of the study.
Of 125 youth participants consented, 5 were removed due to administrative issues. 4 participants were not randomized due to a platform glitch, and 1 consented participant turned out to be ineligible. These 5 were not included in the analysis, so 120 dyads are included in the trial.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control (Standard Care) | Standard Emergency Department services (usual care) |
| FG001 | 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. A-F texting component: Over the course of the 6-week intervention parents in the A-F condition will receive 1 message each day. |
| FG002 | 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. 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) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control (Standard Care) | Standard Emergency Department services (usual care) |
| BG001 | 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. A-F texting component: Over the course of the 6-week intervention parents in the A-F condition will receive 1 message each day. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The data shown here represent potential youth participants who were eligible, as indicators of the dyad because they were the focus of the study. | Posted | Count of Units | Parent-youth dyads | At the time of youth Emergency Department visit | Parent-youth dyads | Parent-youth dyads |
|
Up to 12 weeks
Since all youth participants were enrolled because of emergency dept. visit for suicide risk (ideation or attempts), those who were unreachable at follow-up were not included in denominators of suicide attempts, as they could not be presumed to have or not to have attempted suicide. Thus it is most accurate to report only known data that is based on collected AEs. Non-serious Adverse Events were not collected.
Deaths and Adverse Events were not assessed/monitored in Parents.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Standard care | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicide attempt | Psychiatric disorders | Systematic Assessment | As noted above, those who were unreachable at follow-up were not included in denominators of suicide attempts, as they could not be presumed to have or not to have attempted suicide. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ewa Czyz | University of Michigan | 734 764-9466 | ewac@med.umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 2, 2024 | Mar 18, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 26, 2022 | Oct 25, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D013405 | Suicide |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D020969 | Disease Attributes |
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There are 3 arms: control and 2 intervention arms. One of the intervention arms includes further twice daily (within-person) randomizations.
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| P-F texting component | Behavioral | 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) |
|
| BG002 | 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. 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) |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | dyads |
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| Units |
|---|
| Counts |
|---|
| Participants |
|
| Parent-youth dyads |
|
|
| 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. | Posted | Count of Units | Responses from dyad members | Up to 12 weeks | Responses from dyad members | Responses from dyad members |
|
|
|
| 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). | Posted | Count of Participants | Participants | 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). | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Count of Participants | Participants | Up to 12 weeks |
|
|
|
| 37 |
| 5 |
| 21 |
| 0 |
| 0 |
| EG001 | 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. A-F texting component: Over the course of the 6-week intervention parents in the A-F condition will receive 1 message each day. | 0 | 42 | 2 | 26 | 0 | 0 |
| EG002 | 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. 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) | 0 | 41 | 1 | 23 | 0 | 0 |
|
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| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
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| Unknown or Not Reported |
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