Trial Outcomes & Findings for Developing Text-based Support for Parents of Adolescents After an Emergency Department Visit (NCT NCT05058664)
NCT ID: NCT05058664
Last Updated: 2024-05-16
Results Overview
Data represent participant dyads who were eligible and approached about study participation, and who agreed to take part in the study.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
240 participants
Primary outcome timeframe
At the time of youth Emergency Department visit
Results posted on
2024-05-16
Participant Flow
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.
Participant milestones
| Measure |
Control (Standard Care)
Standard Emergency Department services (usual care)
|
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.
|
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)
|
|---|---|---|---|
|
Overall Study
STARTED
|
37
|
42
|
41
|
|
Overall Study
COMPLETED
|
33
|
42
|
38
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
3
|
Reasons for withdrawal
| Measure |
Control (Standard Care)
Standard Emergency Department services (usual care)
|
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.
|
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)
|
|---|---|---|---|
|
Overall Study
No follow-up data provided
|
4
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
Baseline Characteristics
Developing Text-based Support for Parents of Adolescents After an Emergency Department Visit
Baseline characteristics by cohort
| Measure |
Control (Standard Care)
n=37 Participants
Standard Emergency Department services (usual care)
|
A-F Texting Component
n=42 Participants
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.
|
A-F Texting Plus P-F Texting Component
n=41 Participants
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)
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
Age of adolescent members of dyads
|
15.03 years
STANDARD_DEVIATION 1.42 • n=5 Participants
|
14.55 years
STANDARD_DEVIATION 1.43 • n=7 Participants
|
14.98 years
STANDARD_DEVIATION 1.19 • n=5 Participants
|
14.84 years
STANDARD_DEVIATION 1.36 • n=4 Participants
|
|
Age, Continuous
Age of caregiver members of dyads
|
45.03 years
STANDARD_DEVIATION 8.15 • n=5 Participants
|
43.74 years
STANDARD_DEVIATION 5.89 • n=7 Participants
|
45.20 years
STANDARD_DEVIATION 6.15 • n=5 Participants
|
44.63 years
STANDARD_DEVIATION 6.69 • n=4 Participants
|
|
Sex: Female, Male
Sex of adolescent members of dyads · Female
|
23 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
79 Participants
n=4 Participants
|
|
Sex: Female, Male
Sex of adolescent members of dyads · Male
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Sex: Female, Male
Sex of caregiver members of dyads · Female
|
31 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
106 Participants
n=4 Participants
|
|
Sex: Female, Male
Sex of caregiver members of dyads · Male
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Ethnicity of adolescent members of dyads · Hispanic or Latino
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Ethnicity of adolescent members of dyads · Not Hispanic or Latino
|
28 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
96 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Ethnicity of adolescent members of dyads · Unknown or Not Reported
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Ethnicity of caregiver members of dyads (not collected) · Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Ethnicity of caregiver members of dyads (not collected) · Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Ethnicity of caregiver members of dyads (not collected) · Unknown or Not Reported
|
37 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
120 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Race of adolescent members of dyads · American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Race of adolescent members of dyads · Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Race of adolescent members of dyads · Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Race of adolescent members of dyads · Black or African American
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Race of adolescent members of dyads · White
|
25 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
90 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Race of adolescent members of dyads · More than one race
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Race of adolescent members of dyads · Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Race of caregiver members of dyads · American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Race of caregiver members of dyads · Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Race of caregiver members of dyads · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Race of caregiver members of dyads · Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Race of caregiver members of dyads · White
|
32 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
107 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Race of caregiver members of dyads · More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Race of caregiver members of dyads · Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
37 dyads
n=5 Participants
|
42 dyads
n=7 Participants
|
41 dyads
n=5 Participants
|
120 dyads
n=4 Participants
|
PRIMARY outcome
Timeframe: At the time of youth Emergency Department visitPopulation: The data shown here represent potential youth participants who were eligible, as indicators of the dyad because they were the focus of the study.
Data represent participant dyads who were eligible and approached about study participation, and who agreed to take part in the study.
Outcome measures
| Measure |
Participants Consented
n=207 Parent-youth dyads
Eligible individuals who were approached about study participation and who agreed to take part in the study
|
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.
|
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)
|
|---|---|---|---|
|
Percentage of Eligible Youth-Parent Dyads Who Agree to Participate in the Study,
|
125 Parent-youth dyads
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 12 weeksData 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.
Outcome measures
| Measure |
Participants Consented
n=37 Responses from dyad members
Eligible individuals who were approached about study participation and who agreed to take part in the study
|
A-F Texting Component
n=42 Responses from dyad members
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.
|
A-F Texting Plus P-F Texting Component
n=41 Responses from dyad members
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)
|
|---|---|---|---|
|
Participant Dyads Who Completed Follow-up Assessments
Count of Parent responses
|
33 Responses from dyad members
|
42 Responses from dyad members
|
38 Responses from dyad members
|
|
Participant Dyads Who Completed Follow-up Assessments
Count of Adolescent Responses
|
29 Responses from dyad members
|
35 Responses from dyad members
|
27 Responses from dyad members
|
PRIMARY outcome
Timeframe: Up to 6 weeksResults represent parent participants who did not request stopping the intervention (i.e., did not request to stop receiving messages).
Outcome measures
| Measure |
Participants Consented
n=42 Participants
Eligible individuals who were approached about study participation and who agreed to take part in the study
|
A-F Texting Component
n=41 Participants
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.
|
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)
|
|---|---|---|---|
|
Percentage of Participants Randomized to the Intervention Who Remained Active (Texting Arms Only)
|
42 Participants
|
39 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to 6 weeksMeasured 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).
Outcome measures
| Measure |
Participants Consented
n=39 Participants
Eligible individuals who were approached about study participation and who agreed to take part in the study
|
A-F Texting Component
n=35 Participants
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.
|
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)
|
|---|---|---|---|
|
Participating Parents' Satisfaction With the Intervention (Texting Arms Only)
Recommend to a friend
|
3.56 score on a scale
Standard Deviation 0.55
|
3.43 score on a scale
Standard Deviation 0.66
|
—
|
|
Participating Parents' Satisfaction With the Intervention (Texting Arms Only)
Overall satisfaction
|
3.51 score on a scale
Standard Deviation 0.56
|
3.37 score on a scale
Standard Deviation 0.60
|
—
|
PRIMARY outcome
Timeframe: Up to 12 weeksParent 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.
Outcome measures
| Measure |
Participants Consented
n=37 Participants
Eligible individuals who were approached about study participation and who agreed to take part in the study
|
A-F Texting Component
n=39 Participants
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.
|
A-F Texting Plus P-F Texting Component
n=35 Participants
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)
|
|---|---|---|---|
|
Number of and Reasons for Active Withdrawals
|
0 Participants
|
0 Participants
|
1 Participants
|
Adverse Events
Control
Serious events: 5 serious events
Other events: 0 other events
Deaths: 0 deaths
A-F Texting Component
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
A-F Texting Plus P-F Texting Component
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Control
n=21 participants at risk
Standard care
|
A-F Texting Component
n=26 participants at risk
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.
|
A-F Texting Plus P-F Texting Component
n=23 participants at 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.
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)
|
|---|---|---|---|
|
Psychiatric disorders
Suicide attempt
|
23.8%
5/21 • 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.
|
7.7%
2/26 • 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.
|
4.3%
1/23 • 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.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place