- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06574633
ACEs Referral From PED
Adverse Childhood Experiences (ACEs) Resource Referral Process in the Pediatric Emergency Department
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Georgia
-
Atlanta, Georgia, United States, 30322
- Children's Healthcare of Atlanta at Egleston
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Atlanta, Georgia, United States, 30303
- Children's Healthcare of Atlanta at Hughes Spalding
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Atlanta, Georgia, United States, 30322
- Children's Healthcare of Atlanta (CHOA)
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Atlanta, Georgia, United States, 30329
- Arthur M. Blank Hospital | Children's Healthcare of Atlanta
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients aged 12-17 years seen in the PED who read and speak English
Exclusion Criteria:
- Patients already enrolled in outpatient therapy resources,
- Critically ill patients
- Patients with significant developmental delays impeding their ability to participate in therapy.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Telehealth
|
Participants will be referred to telehealth therapy services when facilitating referral resources by a dedicated behavioral mental health specialist (BMHS).
|
|
Active Comparator: In-person therapy
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Participants will be referred to in-person therapy services when facilitating referral resources by a dedicated behavioral mental health specialist (BMHS).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of attendance between groups after Behavioral Mental Health Specialist (BMHS) referral.
Time Frame: Within 24 weeks after scheduled appointment date
|
Researchers will ask the therapy offices and participants if they were able to make it to the therapy appointment that was scheduled.
|
Within 24 weeks after scheduled appointment date
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Positive Childhood Experiences (PCEs) scores between groups
Time Frame: Baseline and Within 24 weeks after scheduled appointment date
|
Research has determined 7 specific Positive Childhood Experiences, or PCEs, that could be linked to a higher likelihood of positive health outcomes and a reduction in the negative outcomes associated with ACEs or toxic stress. Thinking about your life / your child's life, do you agree with the following statements? (yes/no)
Individuals with high PCE scores have a higher ability to seek social and emotional support and better follow-up rates for therapy services |
Baseline and Within 24 weeks after scheduled appointment date
|
|
Child-reported and caregiver-reported Adverse Childhood Experiences (ACEs) and PCEs
Time Frame: Baseline
|
Adverse childhood experiences (ACEs) are traumatic events that happen between ages 1 and 17. Researchers will use the Pediatric ACEs and Related Life Events Screener (PEARLS). The PEARLS includes an ACE screen (Part 1) as well as a social determinants of health (SDOH) screen (Part 2). ACE screen-10 questions (yes/no) that screen for a history of abuse, neglect, and household dysfunction. The ACE score refers to the total number of ACE categories experienced, rather than the severity or frequency of any one category. The total score ranges between 0 and 10. PEARLS adolescent tool, for ages 12-19, to be completed by a caregiver, and PEARLS for adolescent self-report tool, for ages 12-19, to be completed by the adolescent. Comparison between child-reported ACEs and PCEs and caregiver-reported ACEs and PCEs of their child to determine if there is variability. |
Baseline
|
|
ACEs prevalence by zip code between groups
Time Frame: Baseline
|
Adverse childhood experiences, or ACEs, are potentially traumatic events that occur in childhood (0-17 years).
Researchers will use the Pediatric ACEs and Related Life Events Screener (PEARLS).
The PEARLS includes an ACE screen (yes/no).
The ACE score refers to the total number of ACE categories experienced, rather than the severity or frequency of any one category.
The total score ranges between 0 and 10.
Investigators will analyze the total scores using the zip codes provided by participants.
|
Baseline
|
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Community Resources by zip code
Time Frame: Baseline
|
Community Resources by zip code between groups.
Investigators will analyze the available community resources along with the ACE prevalence in the area using the zip codes provided by participants and compare between groups.
|
Baseline
|
|
Child opportunity index (COI)
Time Frame: Baseline
|
The COI is a composite index of children's neighborhood opportunity that contains data for every neighborhood (census tract) in the United States from every year from 2012 through 2021. It is comprised of 44 indicators in three domains (education, health and environment, and social and economic) and 14 subdomains. . ACEs prevalence with Community Resources and Child Opportunity Index (COI) by zip code Community Resources by zip code between groups. The COI is a composite index of children's neighborhood opportunity that contains data for every neighborhood (census tract) in the United States from every year from 2012 through 2021. It is comprised of 44 indicators in three domains (education, health and environment, and social and economic) and 14 subdomains. Investigators will analyze COI along with ACE prevalence in the area using the zip codes provided by participants and compare between groups. |
Baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Karli S. Okeson, DO, Emory University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- STUDY00008134
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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