Abuse Domestic, Abuse Mental, Abuse Physical, Abuse Verbal, Adolescent Behavior, Emergency Department, HEART, Intimate Partner Violence
Conditions
Brief summary
This is a single-site, randomized, controlled trial. Investigators will evaluate feasibility of the Emergency Department Healthcare Education Assessment and Response for Teen Relationships (ED-HEART) intervention among adolescents age 14-19 years receiving care in the Children's Mercy emergency department.
Detailed description
This study is a mixed methods feasibility evaluation that will use a randomized controlled trial to assess feasibility of Emergency Department Healthcare Education Assessment and Response for Teen Relationships (ED-HEART) (intervention arm: ED-HEART + teen resource list; control arm: enhanced standard care \[standard care + teen resource list\]). Adolescents age 14-19 years will be recruited and enrolled during an emergency department visit. Investigators will evaluate feasibility using the eight Bowen model feasibility constructs: acceptability, demand, implementation, practicality, adaptation, integration, expansion, and limited-efficacy testing. Investigators will also examine theory of planned behavior constructs (attitudes, beliefs, perceived behavioral control, intention) to facilitate exploratory analysis of factors that may contribute to differential outcomes.
Interventions
BEHAVIORALED-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.
Sponsors
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Children's Mercy Hospital Kansas City
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Adolescents will be enrolled in one of two arms: Emergency Department Healthcare Education Assessment and Response for Teen Relationships (ED-HEART) (intervention arm) or Enhanced Usual Care (control arm). Adolescents will complete study surveys at baseline (Baseline Survey; intervention and control arms), immediately post-intervention (Exit Survey, intervention arm), and 12 weeks after intervention delivery (Follow-up Survey, intervention and control arms).
Eligibility
Sex/Gender
ALL
Age
14 Years to 19 Years
Healthy volunteers
Yes
Inclusion criteria
* emergency department (ED) patient 14-19 years of age.
Exclusion criteria
* Developmental delay, severe illness, or cognitive impairment precluding informed consent/assent or completion of study activities, as determined by ED team or study team. * Current ED evaluation for acute sexual assault/abuse. * Current mental or behavioral health symptoms precluding completion of study activities, as determined by ED team or study team. * Caregiver declines to step out to allow assent/consent in private or adolescent declines for caregiver to step out to allow assent/consent or participation in private. * Adolescent is non-English speaking. * Parent is non-English or non-Spanish speaking.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant Acceptability Ratings for Healthcare Provider Discussions on Relationships in ED-Heart Intervention Arm | 12 weeks | 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) |
| Participant Acceptability Ratings for ED-based Relationship Intervention in ED-Heart Intervention Arm | 12 weeks | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ARA Victimization | 12 weeks | 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. |
| Recognition of Abusive Behaviors | 12 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 88 |
| 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. | 87 |
| Total | 175 |
Baseline characteristics
| Characteristic | ED-HEART (Intervention Arm) | Enhanced Standard Care (Control Arm) | Total |
|---|---|---|---|
| Age, Continuous | 16.1 years STANDARD_DEVIATION 1.5 | 15.7 years STANDARD_DEVIATION 1.3 | 15.9 years STANDARD_DEVIATION 1.4 |
| Commercial Insurance | 24 Participants | 31 Participants | 55 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 26 Participants | 26 Participants | 52 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 62 Participants | 60 Participants | 122 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| History of adolescent relationship abuse | 15 Participants | 16 Participants | 31 Participants |
| History of dating History of dating | 76 Participants | 72 Participants | 148 Participants |
| History of dating No history of dating | 12 Participants | 15 Participants | 27 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 24 Participants | 28 Participants | 52 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 5 Participants | 9 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 20 Participants | 17 Participants | 37 Participants |
| Race (NIH/OMB) White | 38 Participants | 34 Participants | 72 Participants |
| Region of Enrollment United States | 88 participants | 87 participants | 175 participants |
| Sex: Female, Male Female | 50 Participants | 51 Participants | 101 Participants |
| Sex: Female, Male Male | 38 Participants | 36 Participants | 74 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 88 | 0 / 87 |
| other Total, other adverse events | 0 / 88 | 0 / 87 |
| serious Total, serious adverse events | 0 / 88 | 0 / 87 |
Outcome results
Primary
Participant Acceptability Ratings for ED-based Relationship Intervention in ED-Heart Intervention Arm
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)
Time frame: 12 weeks
Population: Intervention participants answering follow up survey acceptability of ED-based adolescent relationship intervention
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ED-HEART (Intervention Arm) | Participant Acceptability Ratings for ED-based Relationship Intervention in ED-Heart Intervention Arm | Strongly agree/agree | 34 Participants |
| ED-HEART (Intervention Arm) | Participant Acceptability Ratings for ED-based Relationship Intervention in ED-Heart Intervention Arm | Strongly disagree/disagree/neutral | 11 Participants |
Comparison: Our null hypothesis for the acceptabnility of the ED-Heart was P0 great than or equal to 85% vs. the alternative P0 less than 85%. Acceptability responses were dichotomized to include neutral with strongly disagree/disagree.p-value: 0.038one sample test of proportions
Primary
Participant Acceptability Ratings for Healthcare Provider Discussions on Relationships in ED-Heart Intervention Arm
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)
Time frame: 12 weeks
Population: Intervention participants answering acceptability item 1 on follow up survey
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ED-HEART (Intervention Arm) | Participant Acceptability Ratings for Healthcare Provider Discussions on Relationships in ED-Heart Intervention Arm | Strongly agree/agree | 39 Participants |
| ED-HEART (Intervention Arm) | Participant Acceptability Ratings for Healthcare Provider Discussions on Relationships in ED-Heart Intervention Arm | Strongly disagree/disagree/neutral | 6 Participants |
Comparison: Our null hypothesis for the acceptability was P0 great than or equal to 85% vs. the alternative P0 less than 85%. Acceptability responses were dichotomized to include neutral with strongly disagree/disagree.p-value: 0.622one-sample test of proportions
Secondary
ARA Victimization
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.
Time frame: 12 weeks
Population: Intervention and control arm participants who completed follow up surveys
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ED-HEART (Intervention Arm) | ARA Victimization | 1 Participants |
| Enhanced Standard Care (Control Arm) | ARA Victimization | 5 Participants |
Secondary
Recognition of Abusive Behaviors
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.
Time frame: 12 weeks
Population: Intervention and control arm participants who completed follow up surveys
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ED-HEART (Intervention Arm) | Recognition of Abusive Behaviors | 4.18 score on a scale | Standard Deviation 0.66 |
| Enhanced Standard Care (Control Arm) | Recognition of Abusive Behaviors | 4.26 score on a scale | Standard Deviation 0.54 |