Telephone-Based Care Coordination for Services Addressing Childhood Adversity
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 778
- 主要终点
- Receipt of ACEs-related services
研究概览
简要总结
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:
- Does telephone-based screening and care coordination for children experiencing ACEs increase child receipt of ACEs-related services?
- Does telephone-based screening and care coordination for children experiencing ACEs improve parent health and wellbeing?
- 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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Care Provider)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Receipt of ACEs-related services
时间窗: Between enrollment and follow-up surveys 6-9 months after enrollment
Assessed by whether a child receives an ACEs-related service by 6 months (i.e., at least 1 specific service appointment made and kept, per parent report). We will primarily consider referrals to mental health (child, adult, and family), child development (preschool, early intervention, and specific developmental services), and material resources (e.g., food, housing, income, transportation), although we may include other categories as appropriate, such as services that support psychosocial wellbeing (e.g., school tutoring, sports, exposure to nature) or access to healthcare.
Parent health and Wellbeing: Global Physical Health
时间窗: Between enrollment and follow-up surveys 12-15 months after enrollment
Assessed by Patient-Reported Outcomes Measurement Information System 10 (PROMIS 10) Global Health Scale v1.2.52, which is a general health measure with mental and physical health subscales. Global Physical Health subscale score (calculated from 4 items), T-score range 16.2-67.7, higher score indicates better outcome.
Parent Health and Wellbeing - Global Mental Health
时间窗: Time Frame: Between enrollment and follow-up surveys 12-15 months after enrollment
Assessed by Patient-Reported Outcomes Measurement Information System 10 (PROMIS 10) Global Health Scale v1.2.52, which is a general health measure with mental and physical health subscales. Global Mental Health subscale score (calculated from 4 items), T score range 21.2-67.6, higher score indicates better outcome.
Child social-emotional wellbeing, under the age of 3
时间窗: Between enrollment and follow-up surveys 12-15 months after enrollment
This outcome will be assessed by Ages and Stages Questionnaire: Social-Emotional, 2nd Edition (ASQ:SE) for children under age 3, which assesses children's social-emotional health across domains of self-regulation, compliance, social-communication, adaptive functioning, autonomy, affect, and interaction with people. Range is 0-525 (for the 36 month questionnaire); higher score indicates worse outcome. We will compare the 12-month outcome scores (ASQ:SE Total Score) in the intervention group against the 12-month outcome scores in the control group, controlling for the baseline outcome score, and we may conduct other analyses for this outcome as appropriate.
Child Social-Emotional Wellbeing, ages 3 and older
时间窗: Between enrollment and follow-up surveys 12-15 months after enrollment
This outcome will be assessed by the Strengths and Difficulties Questionnaire (SDQ) for children 3 years and older, which assesses children's wellbeing across domains of emotional, conduct, hyperactivity/inattention, and peer problems, as well as prosocial behavior. Total Difficulties Score Range is 0-40 with higher score indicating worse outcome. We will compare the 12-month outcome scores (SDQ Total Difficulties Score and ASQ:SE Total Score) in the intervention group against the 12-month outcome scores in the control group, controlling for the baseline outcome score, and we may conduct other analyses for this outcome as appropriate.
次要结局
- Receipt of ACEs-related referrals(Between enrollment and follow-up surveys 6-9 months after enrollment)
- Number of ACEs-related referrals per family(By the time of the 6-9 month and 12-15 month follow-up surveys)
- Number of ACEs-related services received per family(By the time of the 6-9 month and 12-15 month follow-up surveys)
- Parent Emotional Wellbeing: Psychological Distress(Longitudinal data collected at baseline, 6-9 months after enrollment, and 12-15 months after enrollment.)
- Parent Emotional Wellbeing: Perceived Stress(Longitudinal data collected at baseline, 6-9 months after enrollment, and 12-15 months after enrollment.)
- Parent Emotional Wellbeing: Parental Stress(Longitudinal data collected at baseline, 6-9 months after enrollment, and 12-15 months after enrollment.)
- Child School Functioning: Attendance(Between enrollment and follow-up surveys 12-15 months after enrollment)
- Child School Functioning: School Readiness, Ages 2-4 years(Between enrollment and follow-up surveys 12-15 months after enrollment)
- Child School Functioning: School Performance, Ages 4 and older(Between enrollment and follow-up surveys 12-15 months after enrollment)
- Child School Functioning: School Relationships, Ages 4 and older(Between enrollment and follow-up surveys 12-15 months after enrollment)
- Family Functioning and Material Resources: Family Health(Longitudinal data collected at baseline, 6-9 months after enrollment, and 12-15 months after enrollment.)
- Family Functioning and Material Resources: Financial Wellbeing(Longitudinal data collected at baseline, 6-9 months after enrollment, and 12-15 months after enrollment.)
- Family Functioning and Material Resources: Hunger(Longitudinal data collected at baseline, 6-9 months after enrollment, and 12-15 months after enrollment.)
- Family Function and Material Resources: Basic Needs(Longitudinal data collected at baseline, 6-9 months after enrollment, and 12-15 months after enrollment.)
研究者
Paul Chung
Professor and Chair, Department of Health Systems Science, Kaiser Permanente Bernard J. Tyson School of Medicine
Kaiser Permanente