Clinical trial NCT05117099: Middle School Success Over Stress
Official title: Supplement: Long-term Effects of the Family Check-up on Depression and Suicide Across Trials and Development
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parenting
Parent-Child Relations
Depression
Self-regulation
Lead sponsor: University of Oregon
Sponsor class: OTHER
Collaborators: name: Case Western Reserve University
First posted: 2021-11-11
Enrollment: 308
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in Parent Mental Health and Well-being (Parent Report)
timeFrame: baseline, 2 months, 4 months, 6 months
measure: Change From Baseline in Parental Stress (Parent Report)
timeFrame: baseline, 2 months, 4 months, 6 months
measure: Change From Baseline in Child Behavior and Emotional Problems (Parent Report)
timeFrame: baseline, 2 months, 4 months, 6 months
measure: Change From Baseline in Youth Depression (Parent Report)
timeFrame: baseline, 2 months, 4 months, 6 months
measure: Change From Baseline in Parenting Skills (Parent Report)
timeFrame: baseline, 2 months, 4 months, 6 months
measure: Change From Baseline in Positive Family Relationships (Parent Report)
timeFrame: baseline, 2 months, 4 months, 6 months
measure: Change From Baseline in Family Conflict (Parent Report)
timeFrame: baseline, 2 months, 4 months, 6 months
measure: Change From Baseline in Youth Depression (Child Report)
timeFrame: baseline, 6 months
measure: Change From Baseline in Positive Family Relationships (Child Report)
timeFrame: baseline, 6 months
measure: Change From Baseline in Family Conflict (Child Report)
timeFrame: baseline, 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: University of Oregon Prevention Science Institute
state: Oregon
Study officials:
affiliation: University of Oregon
name: Elizabeth Stormshak, PhD
role: PRINCIPAL_INVESTIGATOR
References: