Middle School Success Over Stress

Study Overview
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Brief Summary
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It is clear that the COVID-19 pandemic has impacted families adversely in multiple ways, including economic stressors, mental health-related functioning, social/familial functioning, as well as responses to mandated safety measures (e.g. social distancing, stay-at-home orders, mask-wearing). Furthermore, families of school-age children have had to navigate online instruction and home schooling in the context of these difficult circumstances with little preparation for doing so effectively. School districts have varied widely in their ability to support parents during this crisis. These stressors are likely to have disproportionately adverse effects on lower-income and racial/ ethnic minority populations, for whom economic, academic, and family-level challenges were already pronounced. For instance, health effects of COVID-19 have hit African American and Latinx populations with disproportionate severity, including higher rates of hospitalization and death. Given the scale of pandemic impacts for families with school-aged children, the identification of effective family-focused interventions that target core mechanisms of change with a broad range of benefits for parents and youth across diverse populations, and that can be brought to scale rapidly and with fidelity, represent critical public health goals. In this research study the investigators will adapt and test the efficacy of the Family Check-Up Online as a treatment to foster resilient family functioning in response to the COVID-19 pandemic. The investigators will test the effects of the adapted FCU Online program on key mechanisms of change that are predicted to directly impact child and family functioning: parenting skills, parental depression, and parent and child self-regulation. The investigators predict that changes in these key targets of the intervention will impact participant's response to the COVID-19 pandemic, including youth depression and behavior problems, the ability to cope with pandemic-focused stressors, and social/familial functioning.

Official Title
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Supplement: Long-term Effects of the Family Check-up on Depression and Suicide Across Trials and Development

Conditions
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Parenting, Parent-Child Relations, Depression, Self-regulation

Intervention / Treatment
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* Behavioral: Family Check-Up


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A caregiver must have a child between the ages of 10 and 14; the caregiver must be the parent or legal guardian of the participating youth; the caregiver must have a smartphone with text messaging capability and access to email; and the caregiver must score at least 1 or above on the Patient Health Questionnaire-2, or score at least 2 on any item of the Perceived Stress Scale-4. Exclusion Criteria: the caregiver is unable to read in either English or Spanish; the child is unable to complete the survey without parent's help; or the family is already participating in another study of the University of Oregon's Prevention Science Institute.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Families will be assigned to treatment vs. waitlist control. The investigators will assess families at baseline and at 2-, 4-, and 6-month follow-ups. Families in the treatment condition will receive the intervention between baseline and the 2-month follow-up.The control group will receive the intervention following the 4-month assessment.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FCU Online + Coach<br>Parents in this arm will receive access to the FCU Online website and telehealth coaching/ support provided by a trained mental health provider. The FCU Online website includes a brief 5-minute assessment, feedback on parents' responses, and online tools to support parenting in areas that were identified as challenges by the assessment. These tools include videos, animated videos, parenting tips, and interactives to help practice parenting skills.Telehealth coaching sessions will focus on Healthy Behaviors, Positive Parenting, Rules and Consequences, School Support, and Communication. | Behavioral: Family Check-Up<br>* This intervention includes access to the Family Check-Up Online website and telehealth coaching provided by trained mental health providers. A minimum of 5 coaching sessions will be offered.<br>|
| No Intervention: Waitlist Control<br>Parents in this arm will initially serve as the control group but will receive access to the FCU Online website and telehealth coaching after completing three waves of data collection (baseline, 2-mo, and 4-mo follow-up). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline in parent mental health and well-being (parent report) | Parent depression will be measured with the PHQ-9. | baseline, 2 months, 4 months, 6 months | 
| change from baseline in parental stress (parent report) | Parental stress will be measured with the Parenting Stress Index (PSI). | baseline, 2 months, 4 months, 6 months | 
| change from baseline in child behavior and emotional problems (parent report) | Child behavior and emotional problems will be measured with the Strengths and Difficulties Questionnaire (SDQ). | baseline, 2 months, 4 months, 6 months | 
| change from baseline in youth depression (parent report) | Youth depression will be measured with the PHQ-Parent report. | baseline, 2 months, 4 months, 6 months | 
| change from baseline in parenting skills (parent report) | Parenting skills will be measured with the Parenting Young Children Questionnaire (PARYC). | baseline, 2 months, 4 months, 6 months | 
| change from baseline in positive family relationships (parent report) | Positive family relationships will be measured with the CASEY. | baseline, 2 months, 4 months, 6 months | 
| change from baseline in family conflict (parent report) | Family conflict will be measured with the CASEY. | baseline, 2 months, 4 months, 6 months | 
| change from baseline in child self-regulation (parent report) | Child self-regulation will be measured with the Rothbart Child Behavior Questionnaire. | baseline, 2 months, 4 months, 6 months | 
| change from baseline in youth depression (child report) | Youth depression will be measured with the PHQ-9 modified for teens. | baseline, 6 months | 
| change from baseline in child behavior and emotional problems (child report) | Child behavior and emotional problems will be measured with the Strengths and Difficulties Questionnaire (SDQ). | baseline, 6 months | 
| change from baseline in positive family relationships (child report) | Positive family relationships will be measured with the CASEY. | baseline, 6 months | 
| change from baseline in family conflict (child report) | Family conflict will be measured with the CASEY. | baseline, 6 months |