Trial Outcomes & Findings for Emergency Department Healthcare Education Assessment and Response for Teen Relationships: A Pilot Feasibility Study (NCT NCT05194202)
NCT ID: NCT05194202
Last Updated: 2024-11-06
Results Overview
1 survey item (investigator-developed) on acceptability of healthcare providers discussing healthy/unhealthy relationships, rated using 5-point Likert scale (strongly disagree/1 to strongly agree/5)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
175 participants
Primary outcome timeframe
12 weeks
Results posted on
2024-11-06
Participant Flow
Participant milestones
| Measure |
ED-HEART (Intervention Arm)
All adolescents take a baseline survey in the Emergency Department (ED), receive Emergency Department Healthcare Education Assessment and Response for Teen Relationships (ED HEART) by a trained health educator, complete an exit survey while in the ED, complete a 6-week check-in to confirm contact information and aid retention, and complete a 12-week follow up survey.
ED-HEART: Behavioral intervention that addresses 1) healthy and unhealthy relationship behaviors, 2) conversation with partners around boundaries within relationships, 3) harm reduction strategies, and 4) resources for Adolescent Relationship Abuse (ARA) and related concerns, including Point of Care (POC) Reproductive and Sexual Health (RSH) harm reduction resources.
|
Enhanced Standard Care (Control Arm)
All adolescents take a baseline survey in the Emergency Department (ED), receive enhanced standard care (i.e., standard care + teen resource list), complete a 6-week check in to confirm contact information and aid retention, and complete a 12-week follow up survey.
|
|---|---|---|
|
Overall Study
STARTED
|
88
|
87
|
|
Overall Study
COMPLETED
|
39
|
39
|
|
Overall Study
NOT COMPLETED
|
49
|
48
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Emergency Department Healthcare Education Assessment and Response for Teen Relationships: A Pilot Feasibility Study
Baseline characteristics by cohort
| Measure |
ED-HEART (Intervention Arm)
n=88 Participants
All adolescents take a baseline survey in the Emergency Department (ED), receive Emergency Department Healthcare Education Assessment and Response for Teen Relationships (ED HEART) by a trained health educator, complete an exit survey while in the ED, complete a 6-week check-in to confirm contact information and aid retention, and complete a 12-week follow up survey.
ED-HEART: Behavioral intervention that addresses 1) healthy and unhealthy relationship behaviors, 2) conversation with partners around boundaries within relationships, 3) harm reduction strategies, and 4) resources for Adolescent Relationship Abuse (ARA) and related concerns, including Point of Care (POC) Reproductive and Sexual Health (RSH) harm reduction resources.
|
Enhanced Standard Care (Control Arm)
n=87 Participants
All adolescents take a baseline survey in the Emergency Department (ED), receive enhanced standard care (i.e., standard care + teen resource list), complete a 6-week check in to confirm contact information and aid retention, and complete a 12-week follow up survey.
|
Total
n=175 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
16.1 years
STANDARD_DEVIATION 1.5 • n=5 Participants
|
15.7 years
STANDARD_DEVIATION 1.3 • n=7 Participants
|
15.9 years
STANDARD_DEVIATION 1.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
26 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
62 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
24 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
20 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
88 participants
n=5 Participants
|
87 participants
n=7 Participants
|
175 participants
n=5 Participants
|
|
Commercial Insurance
|
24 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
History of adolescent relationship abuse
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
History of dating
History of dating
|
76 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
148 Participants
n=5 Participants
|
|
History of dating
No history of dating
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Intervention participants answering acceptability item 1 on follow up survey
1 survey item (investigator-developed) on acceptability of healthcare providers discussing healthy/unhealthy relationships, rated using 5-point Likert scale (strongly disagree/1 to strongly agree/5)
Outcome measures
| Measure |
ED-HEART (Intervention Arm)
n=45 Participants
All adolescents take a baseline survey in the Emergency Department (ED), receive Emergency Department Healthcare Education Assessment and Response for Teen Relationships (ED HEART) by a trained health educator, complete an exit survey while in the ED, complete a 6-week check-in to confirm contact information and aid retention, and complete a 12-week follow up survey.
ED-HEART: Behavioral intervention that assesses 1) healthy and unhealthy relationship behaviors, 2) conversation with partners around boundaries within relationships, 3) harm reduction strategies, and 4) resources for Adolescent Relationship Abuse (ARA) and related concerns, including Point of Care (POC) Reproductive and Sexual Health (RSH) harm reduction resources.
|
Enhanced Standard Care (Control Arm)
All adolescents take a baseline survey in the Emergency Department (ED), receive enhanced standard care (i.e., standard care + teen resource list), complete a 6-week check in to confirm contact information and aid retention, and complete a 12-week follow up survey.
|
|---|---|---|
|
Participant Acceptability Ratings for Healthcare Provider Discussions on Relationships in ED-Heart Intervention Arm
Strongly agree/agree
|
39 Participants
|
—
|
|
Participant Acceptability Ratings for Healthcare Provider Discussions on Relationships in ED-Heart Intervention Arm
Strongly disagree/disagree/neutral
|
6 Participants
|
—
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Intervention participants answering follow up survey acceptability of ED-based adolescent relationship intervention
1 survey item (investigator-developed) on acceptability of emergency department based healthy/unhealthy relationships intervention, rated using 5-point Likert scale (strongly disagree/1 to strongly agree/5)
Outcome measures
| Measure |
ED-HEART (Intervention Arm)
n=45 Participants
All adolescents take a baseline survey in the Emergency Department (ED), receive Emergency Department Healthcare Education Assessment and Response for Teen Relationships (ED HEART) by a trained health educator, complete an exit survey while in the ED, complete a 6-week check-in to confirm contact information and aid retention, and complete a 12-week follow up survey.
ED-HEART: Behavioral intervention that assesses 1) healthy and unhealthy relationship behaviors, 2) conversation with partners around boundaries within relationships, 3) harm reduction strategies, and 4) resources for Adolescent Relationship Abuse (ARA) and related concerns, including Point of Care (POC) Reproductive and Sexual Health (RSH) harm reduction resources.
|
Enhanced Standard Care (Control Arm)
All adolescents take a baseline survey in the Emergency Department (ED), receive enhanced standard care (i.e., standard care + teen resource list), complete a 6-week check in to confirm contact information and aid retention, and complete a 12-week follow up survey.
|
|---|---|---|
|
Participant Acceptability Ratings for ED-based Relationship Intervention in ED-Heart Intervention Arm
Strongly agree/agree
|
34 Participants
|
—
|
|
Participant Acceptability Ratings for ED-based Relationship Intervention in ED-Heart Intervention Arm
Strongly disagree/disagree/neutral
|
11 Participants
|
—
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Intervention and control arm participants who completed follow up surveys
Report of ARA victimization will be considered positive for any positive answer to one or more of six survey items assessing physical ARA, sexual ARA, sexual exploitation within a dating relationship, and (among females) reproductive coercion.
Outcome measures
| Measure |
ED-HEART (Intervention Arm)
n=47 Participants
All adolescents take a baseline survey in the Emergency Department (ED), receive Emergency Department Healthcare Education Assessment and Response for Teen Relationships (ED HEART) by a trained health educator, complete an exit survey while in the ED, complete a 6-week check-in to confirm contact information and aid retention, and complete a 12-week follow up survey.
ED-HEART: Behavioral intervention that assesses 1) healthy and unhealthy relationship behaviors, 2) conversation with partners around boundaries within relationships, 3) harm reduction strategies, and 4) resources for Adolescent Relationship Abuse (ARA) and related concerns, including Point of Care (POC) Reproductive and Sexual Health (RSH) harm reduction resources.
|
Enhanced Standard Care (Control Arm)
n=54 Participants
All adolescents take a baseline survey in the Emergency Department (ED), receive enhanced standard care (i.e., standard care + teen resource list), complete a 6-week check in to confirm contact information and aid retention, and complete a 12-week follow up survey.
|
|---|---|---|
|
ARA Victimization
|
1 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Intervention and control arm participants who completed follow up surveys
19 survey items, adapted from the Recognition of ARA Scale. Each item answered with 5-point Likert scale that categorizes each behavior from not abusive (1) to extremely abusive (5). Scored as mean; higher score indicates increased recognition of behaviors as abusive.
Outcome measures
| Measure |
ED-HEART (Intervention Arm)
n=47 Participants
All adolescents take a baseline survey in the Emergency Department (ED), receive Emergency Department Healthcare Education Assessment and Response for Teen Relationships (ED HEART) by a trained health educator, complete an exit survey while in the ED, complete a 6-week check-in to confirm contact information and aid retention, and complete a 12-week follow up survey.
ED-HEART: Behavioral intervention that assesses 1) healthy and unhealthy relationship behaviors, 2) conversation with partners around boundaries within relationships, 3) harm reduction strategies, and 4) resources for Adolescent Relationship Abuse (ARA) and related concerns, including Point of Care (POC) Reproductive and Sexual Health (RSH) harm reduction resources.
|
Enhanced Standard Care (Control Arm)
n=54 Participants
All adolescents take a baseline survey in the Emergency Department (ED), receive enhanced standard care (i.e., standard care + teen resource list), complete a 6-week check in to confirm contact information and aid retention, and complete a 12-week follow up survey.
|
|---|---|---|
|
Recognition of Abusive Behaviors
|
4.18 score on a scale
Standard Deviation 0.66
|
4.26 score on a scale
Standard Deviation 0.54
|
Adverse Events
ED-HEART (Intervention Arm)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Enhanced Standard Care (Control Arm)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place