N/A
N=308
Middle School Success Over Stress
Parenting · Parent-Child Relations · Depression · Self-regulation
Bottom Line
View on ClinicalTrials.gov: NCT05117099 ↗Enrolled (actual)
308
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcome: Primary: Change From Baseline in Parent Mental Health and Well-being (Parent Report) — .7442; .7523; .6484; .5571 score on a scale — p=.548
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Family Check-Up (Behavioral)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- University of Oregon
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Parent Mental Health and Well-being (Parent Report) |
.7442; .7523; .6484; .5571; .6182; .4903 | .548 |
| PRIMARY Change From Baseline in Parental Stress (Parent Report) |
1.8205; 1.8341; 1.8033; 1.5365; 1.7616; 1.5351 | — |
| PRIMARY Change From Baseline in Child Behavior and Emotional Problems (Parent Report) |
13.2184; 14.2568; 12.8630; 12.2143; 11.6056; 12.1587 | .915 |
| PRIMARY Change From Baseline in Youth Depression (Parent Report) |
.6092; .6937; .5219; .5423; .4589; .4925 | .663 |
| PRIMARY Change From Baseline in Parenting Skills (Parent Report) |
2.9253; 2.9122; 2.8611; 3.1286; 2.9155; 3.1532 | .138 |
| PRIMARY Change From Baseline in Positive Family Relationships (Parent Report) |
3.3798; 3.4189; 3.3014; 3.6833; 3.4437; 3.7566 | .114 |
| PRIMARY Change From Baseline in Family Conflict (Parent Report) |
1.8046; 1.8559; 1.7637; 1.5202; 1.6725; 1.3254 | .065 |
| PRIMARY Change From Baseline in Youth Depression (Child Report) |
1.7708; 1.6029; 1.8070; 1.7596 | .394 |
| PRIMARY Change From Baseline in Positive Family Relationships (Child Report) |
3.6061; 3.5699; 3.4453; 3.4909 | .388 |
| PRIMARY Change From Baseline in Family Conflict (Child Report) |
2.6184; 2.8640; 2.5323; 2.6636 | .332 |
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.
Data sourced from ClinicalTrials.gov (NCT05117099). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.