Suicide
Conditions
Keywords
Emergency Department
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.
Interventions
BEHAVIORALA-F texting component
Over the course of the 6-week intervention parents in the A-F condition will receive 1 message each day.
BEHAVIORALP-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)
Sponsors
National Institute of Mental Health (NIMH)
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Intervention model description
There are 3 arms: control and 2 intervention arms. One of the intervention arms includes further twice daily (within-person) randomizations.
Eligibility
Sex/Gender
ALL
Age
13 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Eligible Youth-Parent Dyads Who Agree to Participate in the Study, | 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 | 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) | 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) | 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 | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Control (Standard Care) Standard Emergency Department services (usual care) | 37 |
| 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. | 42 |
| 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) | 41 |
| Total | 120 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | No follow-up data provided | 4 | 0 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Control (Standard Care) | A-F Texting Component | A-F Texting Plus P-F Texting Component | Total |
|---|---|---|---|---|
| Age, Continuous Age of adolescent members of dyads | 15.03 years STANDARD_DEVIATION 1.42 | 14.55 years STANDARD_DEVIATION 1.43 | 14.98 years STANDARD_DEVIATION 1.19 | 14.84 years STANDARD_DEVIATION 1.36 |
| Age, Continuous Age of caregiver members of dyads | 45.03 years STANDARD_DEVIATION 8.15 | 43.74 years STANDARD_DEVIATION 5.89 | 45.20 years STANDARD_DEVIATION 6.15 | 44.63 years STANDARD_DEVIATION 6.69 |
| Ethnicity (NIH/OMB) Ethnicity of adolescent members of dyads Hispanic or Latino | 4 Participants | 2 Participants | 3 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Ethnicity of adolescent members of dyads Not Hispanic or Latino | 28 Participants | 36 Participants | 32 Participants | 96 Participants |
| Ethnicity (NIH/OMB) Ethnicity of adolescent members of dyads Unknown or Not Reported | 5 Participants | 4 Participants | 6 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Ethnicity of caregiver members of dyads (not collected) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Ethnicity of caregiver members of dyads (not collected) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Ethnicity of caregiver members of dyads (not collected) Unknown or Not Reported | 37 Participants | 42 Participants | 41 Participants | 120 Participants |
| Race (NIH/OMB) Race of adolescent members of dyads American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Race of adolescent members of dyads Asian | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Race of adolescent members of dyads Black or African American | 2 Participants | 4 Participants | 3 Participants | 9 Participants |
| Race (NIH/OMB) Race of adolescent members of dyads More than one race | 4 Participants | 4 Participants | 1 Participants | 9 Participants |
| Race (NIH/OMB) Race of adolescent members of dyads Native Hawaiian or Other Pacific Islander | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Race of adolescent members of dyads Unknown or Not Reported | 2 Participants | 0 Participants | 4 Participants | 6 Participants |
| Race (NIH/OMB) Race of adolescent members of dyads White | 25 Participants | 34 Participants | 31 Participants | 90 Participants |
| Race (NIH/OMB) Race of caregiver members of dyads American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Race of caregiver members of dyads Asian | 2 Participants | 0 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Race of caregiver members of dyads Black or African American | 2 Participants | 2 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) Race of caregiver members of dyads More than one race | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Race of caregiver members of dyads Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Race of caregiver members of dyads Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Race of caregiver members of dyads White | 32 Participants | 38 Participants | 37 Participants | 107 Participants |
| Region of Enrollment United States | 37 dyads | 42 dyads | 41 dyads | 120 dyads |
| Sex: Female, Male Sex of adolescent members of dyads Female | 23 Participants | 29 Participants | 27 Participants | 79 Participants |
| Sex: Female, Male Sex of adolescent members of dyads Male | 14 Participants | 13 Participants | 14 Participants | 41 Participants |
| Sex: Female, Male Sex of caregiver members of dyads Female | 31 Participants | 38 Participants | 37 Participants | 106 Participants |
| Sex: Female, Male Sex of caregiver members of dyads Male | 6 Participants | 4 Participants | 4 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 37 | 0 / 42 | 0 / 41 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 5 / 21 | 2 / 26 | 1 / 23 |
Outcome results
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.
Time frame: Up to 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants Consented | Number of and Reasons for Active Withdrawals | 0 Participants |
| A-F Texting Component | Number of and Reasons for Active Withdrawals | 0 Participants |
| A-F Texting Plus P-F Texting Component | Number of and Reasons for Active Withdrawals | 1 Participants |
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.
Time frame: Up to 12 weeks
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Participants Consented | Participant Dyads Who Completed Follow-up Assessments | Count of Adolescent Responses | 29 Responses from dyad members |
| Participants Consented | Participant Dyads Who Completed Follow-up Assessments | Count of Parent responses | 33 Responses from dyad members |
| A-F Texting Component | Participant Dyads Who Completed Follow-up Assessments | Count of Adolescent Responses | 35 Responses from dyad members |
| A-F Texting Component | Participant Dyads Who Completed Follow-up Assessments | Count of Parent responses | 42 Responses from dyad members |
| A-F Texting Plus P-F Texting Component | Participant Dyads Who Completed Follow-up Assessments | Count of Parent responses | 38 Responses from dyad members |
| A-F Texting Plus P-F Texting Component | Participant Dyads Who Completed Follow-up Assessments | Count of Adolescent Responses | 27 Responses from dyad members |
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).
Time frame: Up to 6 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Consented | Participating Parents' Satisfaction With the Intervention (Texting Arms Only) | Overall satisfaction | 3.51 score on a scale | Standard Deviation 0.56 |
| Participants Consented | Participating Parents' Satisfaction With the Intervention (Texting Arms Only) | Recommend to a friend | 3.56 score on a scale | Standard Deviation 0.55 |
| A-F Texting Component | Participating Parents' Satisfaction With the Intervention (Texting Arms Only) | Recommend to a friend | 3.43 score on a scale | Standard Deviation 0.66 |
| A-F Texting Component | Participating Parents' Satisfaction With the Intervention (Texting Arms Only) | Overall satisfaction | 3.37 score on a scale | Standard Deviation 0.6 |
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.
Time frame: At the time of youth Emergency Department visit
Population: The data shown here represent potential youth participants who were eligible, as indicators of the dyad because they were the focus of the study.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Participants Consented | Percentage of Eligible Youth-Parent Dyads Who Agree to Participate in the Study, | 125 Parent-youth dyads |
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).
Time frame: Up to 6 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants Consented | Percentage of Participants Randomized to the Intervention Who Remained Active (Texting Arms Only) | 42 Participants |
| A-F Texting Component | Percentage of Participants Randomized to the Intervention Who Remained Active (Texting Arms Only) | 39 Participants |