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Completed

NCT Number: NCT05117099

Middle School Success Over Stress

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.

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Key information

Conditions

Parenting Behavior Behavioral Symptoms Depression Parent-Child Relations Self-Control Self-regulation Social Behavior

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Oregon Prevention Science Institute

Portland, Oregon, 97209, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Family Check-Up

Behavioral

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.

Primary outcomes

  1. Change From Baseline in Parent Mental Health and Well-being (Parent Report)

    Time frame: baseline, 2 months, 4 months, 6 months

    Parents reported on their depressive symptoms using the Patient Health Questionnaire (PHQ-9), a 9-item brief depression screening questionnaire. Parents were asked to indicate the extent to which statements were true of their mood in the past two weeks using a 4-pt scale (not at all, several days, more than half the days, nearly every day). Scores ranged from 0-3. High scores indicate greater depressive symptoms.

  2. Change From Baseline in Parental Stress (Parent Report)

    Time frame: baseline, 2 months, 4 months, 6 months

    Parents reported on their parenting stress using the Parenting Stress Index (PSI), a 14-item questionnaire. Parents were asked to indicate the extent to which statements were true of their experience in the past month using a 5-pt scale (never, almost never, sometimes, fairly often, very often). Scores ranged from 0-4. High scores indicate greater parenting stress.

  3. Change From Baseline in Child Behavior and Emotional Problems (Parent Report)

    Time frame: baseline, 2 months, 4 months, 6 months

    Parents reported on their child's problem behavior using the Strengths and Difficulties Questionnaire (SDQ), a 25-item brief behavioral screening questionnaire that consists of 5 subscales with 5 questions each. The 5 subscales are conduct problems, emotional problems, hyperactivity, peer problems, and prosocial behavior. Parents were asked to indicate the extent to which statements were true of their child's behavior in the past month using a 3-pt scale (not true, somewhat true, and certainly true). Response options for each item ranged from 0-2. Subscale totals were created by summing responses for a possible range of 0-10 for each subscale. The sums from each subscale were summed to create a composite score. High scores indicate greater conduct problems.

  4. Change From Baseline in Youth Depression (Parent Report)

    Time frame: baseline, 2 months, 4 months, 6 months

    Parents reported on their child's depressive symptoms using the Patient Health Questionnaire (PHQ-9), a 9-item brief depression screening questionnaire. Parents were asked to indicate the extent to which statements were true of their child's mood in the past two weeks using a 4-pt scale (not at all, several days, more than half the days, nearly every day). Scores ranged from 0-3. High scores indicate greater depressive symptoms.

  5. Change From Baseline in Parenting Skills (Parent Report)

    Time frame: baseline, 2 months, 4 months, 6 months

    Parents reported on their parenting skills using a version of the Parenting Young Children Questionnaire (PARYC). The PARYC version adapted for this study was a 21-item questionnaire. Parents were asked to indicate the extent to which statements were true of their child's behavior in the past month using a 5-pt scale (never, rarely, sometimes, often, and very often). Scores for each item ranged from 0-4, and scores were averaged to create a total score. High scores indicate greater parenting skills.

  6. Change From Baseline in Positive Family Relationships (Parent Report)

    Time frame: baseline, 2 months, 4 months, 6 months

    Parents reported on their family relationships using a "family togetherness" scale adapted from the Community Action for Successful Youth (CASEY) questionnaire. The scale used for this study consisted of 3 items. Parents were asked to indicate the extent to which statements were true of their experience in the past month using a 5-pt scale (never true, sometimes true, true about half the time, often true, and always true). Scores ranged from 1-5. High scores indicate greater positive family relationships.

  7. Change From Baseline in Family Conflict (Parent Report)

    Time frame: baseline, 2 months, 4 months, 6 months

    Parents reported on their family conflict using a "family conflict" scale adapted from the Community Action for Successful Youth (CASEY) questionnaire. The scale used for this study consisted of 4 items. Parents were asked to indicate the extent to which statements were true of their experience in the past month using a 7-pt scale (never, once, twice, 3 times, 4 or 5 times, 6 or 7 times and more than 7 times). Scores for each item ranged from 0-6, and scores were averaged to create a total score. High scores indicate increased family conflict.

  8. Change From Baseline in Youth Depression (Child Report)

    Time frame: baseline, 6 months

    Youth reported on their depressive symptoms using the Patient Health Questionnaire (PHQ-9), a 9-item brief depression screening questionnaire modified for teen use. Youth were asked to indicate the extent to which statements were true of their mood in the past two weeks using a 4-pt scale (not at all, several days, more than half the days, nearly every day). Scores for each item ranged from 1-4, and scores were averaged to create a total score. High scores indicate greater depressive symptoms.

  9. Change From Baseline in Positive Family Relationships (Child Report)

    Time frame: baseline, 6 months

    Youth reported on their family relationships using a "family togetherness" scale adapted from the Community Action for Successful Youth (CASEY) questionnaire. The scale used for this study consisted of 3 items. Youth were asked to indicate the extent to which statements were true of their experience in the past month using a 5-pt scale (never true, sometimes true, true about half the time, often true, and always true). Scores ranged from 1-5. High scores indicate greater positive family relationships.

  10. Change From Baseline in Family Conflict (Child Report)

    Time frame: baseline, 6 months

    Youth reported on their family conflict using a "family conflict" scale adapted from the Community Action for Successful Youth (CASEY) questionnaire. The scale used for this study consisted of 4 items. Youth were asked to indicate the extent to which statements were true of their experience in the past month using a 7-pt scale (never, once, twice, 3 times, 4 or 5 times, 6 or 7 times and more than 7 times). Scores ranged from 1-7. High scores indicate increased family conflict.

Sponsors and collaborators

Lead sponsor

University of Oregon

Other

Collaborators

  • Case Western Reserve University

Registry information

Official study title

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

Acronym: MSSOS

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Nov 11, 2021
Registry last updated
Apr 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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