Summary

Healthy Volunteers
healthy people welcome
Dates
study started
study ends around
Principal Investigator
by Rebecca N Dudovitz, MD, MS

Description

Summary

The goal of this study is to learn how telephone-based screening and care coordination impacts children experiencing adverse childhood events (ACEs). The main questions are:

  1. Does telephone-based screening and care coordination for children experiencing ACEs increase child receipt of ACEs-related services?
  2. Does telephone-based screening and care coordination for children experiencing ACEs improve parent health and wellbeing?
  3. Does telephone-based screening and care coordination for children experiencing ACEs improve child social and emotional health?

Researchers will compare families who have been randomly selected to receive telephone-based screening and care coordination with those who will receive usual care at their clinic.

Participants will:

  • Be randomly assigned to receive usual care or usual care plus telephone-based screening and care coordination (the intervention)
  • If selected for the intervention, be connected to 211 Los Angeles to receive screening and care coordination for up to 6 months
  • Complete four surveys via interview; surveys will be done at enrollment and 1 month, 6 months, and 12 months following enrollment
  • Agree to allow researchers to review their child's medical records to collect information about their child's health, screenings, diagnoses, and referrals.

Details

Throughout the recruitment period, clinic partners will send an opt-out letter or text message to all families with an upcoming well-child visit in the next month, providing instructions for how families can opt out of study recruitment efforts. Those who do not opt out may be contacted by phone by the study team. Potential participants will be selected for contact from a clinic's appointment list utilizing a random number generator roughly one month prior to their scheduled well-child visit to invite them to participate. Invitations will continue until weekly quotas for enrollment are met. Upon contacting the family, the study team Research Associate will screen for eligibility and explain the study.

If the child is eligible and the family is interested in participating, the RA will obtain electronic parent permission and consent for study participation and electronic HIPAA authorization for research for the study team to obtain information from the medical chart.

Following the consent process, the research team will administer the baseline survey over the phone. The survey will include socio-demographic characteristics as well as measures for family functioning and material resources and parent and child health and wellbeing.

Following baseline survey completion, children will be individually randomized to the intervention or control group. Randomization will be stratified by clinic system to ensure even representation across intervention and control groups in each clinic system. To determine group assignment, the RA will enter the clinic in REDCap, which will reveal the assigned group (intervention or control) using a permuted block randomization list generated by the statistician. The RA will provide the participant with their group assignment at this time as well as briefly describe the intervention further for the intervention group.

After randomization is complete, those in the intervention group will be connected to 211 LA via warm transfer phone call or by providing the family's contact information to 211 LA. Once connected to the parent, the 211 LA Care Coordination specialist will conduct ACEs screening over the phone using the PEARLS Part 1 and Part 2 questionnaire. Based on the ACEs screening results, 211 LA will provide information about and connection to relevant evaluations and services, with specific attention to mental health, child development, and material needs and services. The care coordinator specialist will stay in touch with the family (contacting families 1 or 2 times per month based on coordinator-assessed need) for up to 6 months, until the parent wishes to discontinue contact, or the child is enrolled in all desired services. Families are encouraged to call 211 LA with additional questions or concerns.

Both intervention and control group families will receive usual well-child care and ACEs screening using the PEARLS in the clinic. Providers will provide referrals and care coordination per their current practices and will be blinded as to study group assignment during the intervention.

In addition to the baseline survey, participants will be contacted by the research team via phone roughly 1 month following enrollment to learn about any initial referrals the family received through either the clinic or 211 LA. In addition, parents will be asked to complete a follow-up survey over the phone at 6 and 12 months following enrollment, for a total of four surveys. After completion of each survey, parents will receive a monetary incentive to compensate them for their time.

The study team will also obtain intervention group data from 211 LA regarding ACEs screening results, referrals, and referral outcomes. Finally, the study team will review charts 6 months after enrollment for both intervention and control groups regarding clinic-based ACEs screening results, referrals, and services.

Study data will be collected and managed using REDCap (Research Electronic Data Capture), a secure web application designed to support data capture for research studies, providing web-based case report forms, real-time data entry validation, audit trails, and a de-identified data export to common statistical packages.

Keywords

Health Services, Mental Health, Well-being, child health, adverse childhood experiences, care coordination, parent health, parent mental health, child mental health, Psychological Well-Being, Telephone-based Screening and Care Coordination

Eligibility

You can join if…

  • Parent or legal guardian of focal child
  • Comfortable completing surveys in English or Spanish
  • Focal child is less than 12 years of age at enrollment

You CAN'T join if...

  • Focal child participated in the 'UCANN" pilot study
  • Focal child's sibling is enrolled in this study
  • Focal child is currently assigned a DCFS (Department of Child and Family Services) case worker

Lead Scientist at UCLA

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Paul Chung
ID
NCT07686614
Study Type
Interventional
Participants
Expecting 778 study participants
Last Updated