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Provider Training for ACE Discussions in Child Development

N/A
Waitlist Available
Led By Abigail Lott, PhD, ABPP
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1 week post-intervention, 6 months follow up, 18 months follow up
Awards & highlights

Study Summary

This trial will test whether provider-led discussions about caregivers' own ACEs can lead to improved child health.

Who is the study for?
This study is for caregivers bringing children to specific well-child checkups (4, 6, 9, 15, or 18 months) at the MCC. Participants should be able to speak and read English or Spanish fluently. Caregivers under age 18 or previously enrolled with another child are excluded.Check my eligibility
What is being tested?
The trial tests if caregiver training on Adverse Childhood Experiences (ACEs) can reduce their children's emergency visits and missed appointments by increasing awareness of ACEs' impact on child health.See study design
What are the potential side effects?
Since this trial involves educational training rather than medical interventions, traditional side effects are not applicable. However, discussing ACEs may cause emotional discomfort.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1 week post-intervention, 6 months follow up, 18 months follow up
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 week post-intervention, 6 months follow up, 18 months follow up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of emergency department (ED) visits documented in chart at 18 months post-intervention
Number of medical visits at Mercy Care at 18 months post-intervention
Number or urgent care (UC) visits documented in chart at 18 months post-intervention
Secondary outcome measures
Attendance at well child check (WCC) visits at 18 months post-intervention
Change in Brief Resilience Scale score from baseline
Change in Parenting Questionnaire (PQ) warmth subscale (PQ-warmth) score from Baseline
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention ArmExperimental Treatment1 Intervention
Intervention providers will undergo training for ACEs screening and discussion. Eligible families will be enrolled into the study at the intake of their child's 4-month, 6-month, 9-month, 15-month, or 18-month well child check. Caregivers will complete the intake surveys including demographics, caregiver ACEs, resilience, warmth, PTSD, and depression. The providers will lead a discussion regarding the impact of caregiver ACEs. Patients will be contacted 1-week, 6-months, and 18-months following their enrollment to obtain repeat measures of the survey instruments. At the 18-month time point, the electronic medical record (EMR) will be queried to obtain outcome measures.
Group II: Standard of Care ArmActive Control1 Intervention
During the study period, standard of care providers will continue to provide standard of care treatment(s); however, families receiving care from the standard of care providers will complete all study surveys. Instead of ACEs training, standard of care providers will undergo training on study procedures including obtaining survey instruments from caregivers and proper storage of survey instruments. This training will stress the importance of not reviewing caregiver ACE scores and minimizing possible treatment contamination. However, standard of care providers will still be able to provide resources to the families as part of standard of care.

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Who is running the clinical trial?

Emory UniversityLead Sponsor
1,627 Previous Clinical Trials
2,560,584 Total Patients Enrolled
Centers for Disease Control and PreventionFED
873 Previous Clinical Trials
22,467,399 Total Patients Enrolled
Abigail Lott, PhD, ABPPPrincipal InvestigatorEmory University

Media Library

Training for ACEs and study procedures Clinical Trial Eligibility Overview. Trial Name: NCT05013138 — N/A
Child Development Research Study Groups: Standard of Care Arm, Intervention Arm
Child Development Clinical Trial 2023: Training for ACEs and study procedures Highlights & Side Effects. Trial Name: NCT05013138 — N/A
Training for ACEs and study procedures 2023 Treatment Timeline for Medical Study. Trial Name: NCT05013138 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are actively involved in this research?

"Affirmative. The clinicaltrial.gov website demonstrates that this experiment is presently recruiting participants, with an initial posted date of April 29th 2022 and most recent update occurring on the same day. 840 individuals must be enrolled from a single medical facility to complete the study."

Answered by AI

Is registration open for this clinical experiment currently?

"Affirmative. As indicated on clinicialtrials.gov, this medical experiment was initially posted April 29th of 2022 and most recently altered that same day. 840 individuals need to be recruited across a single medical centre for the trial to move forward."

Answered by AI

What is the purpose of this clinical research endeavor?

"The primary goal of this investigation, which will be tracked over an 18 month period after the introduction of the intervention, is to measure the number of emergency department visits noted in medical charts. Secondary objectives include analyzing changes in a Brief Resilience Score (BRS) from baseline, measuring variations in parental warmth through a 13-item subscale (PQ-warmth), and ascertaining how many patients are referred to Division of Family and Child Services during follow up."

Answered by AI

Who else is applying?

What state do they live in?
Georgia
What site did they apply to?
Mercy Care Chamblee
What portion of applicants met pre-screening criteria?
Did not meet criteria
~32 spots leftby Sep 2024