Middle School Success Over Stress

NCT05117099 | Completed Results

• 1 other identifier: 3R01MH122213-01S1
• Study Type: interventional
• Target: 308
• Locations: 1 country
• Sites: 1

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.

Conditions

Parenting; Parent-Child Relations; Depression; Self-regulation

Outcome Measures

Primary Outcomes (10)

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

  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.

  baseline, 2 months, 4 months, 6 months

• Change From Baseline in Parental Stress (Parent Report)

  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.

  baseline, 2 months, 4 months, 6 months

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

  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.

  baseline, 2 months, 4 months, 6 months

• Change From Baseline in Youth Depression (Parent Report)

  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.

  baseline, 2 months, 4 months, 6 months

• Change From Baseline in Parenting Skills (Parent Report)

  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.

  baseline, 2 months, 4 months, 6 months

• Change From Baseline in Positive Family Relationships (Parent Report)

  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.

  baseline, 2 months, 4 months, 6 months

• Change From Baseline in Family Conflict (Parent Report)

  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.

  baseline, 2 months, 4 months, 6 months

• Change From Baseline in Youth Depression (Child Report)

  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.

  baseline, 6 months

• Change From Baseline in Positive Family Relationships (Child Report)

  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.

  baseline, 6 months

• Change From Baseline in Family Conflict (Child Report)

  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.

  baseline, 6 months

Study Arms (2)

FCU Online + Coach

EXPERIMENTAL

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

Waitlist Control

NO INTERVENTION

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).

Interventions

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.

FCU Online + Coach

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oregon: lead
• Case Western Reserve University: collaborator

Study Sites (1)

University of Oregon Prevention Science Institute

Portland, Oregon, 97209, United States

Location

Related Publications (2)

• Stormshak E, Connell A, Mauricio AM, McLaughlin M, Caruthers A. Digital Health Delivery of Parenting Skills to Improve Conduct Problems in Middle School Youth Across Two Distinct Randomized Trials. Prev Sci. 2025 May;26(4):582-591. doi: 10.1007/s11121-024-01750-2. Epub 2024 Nov 18.

  PMID: 39556238 DERIVED

• Mauricio AM, Hails KA, Caruthers AS, Connell AM, Stormshak EA. Family Check-Up Online: Effects of a Virtual Randomized Trial on Parent Stress, Parenting, and Child Outcomes in Early Adolescence. Prev Sci. 2024 Sep 24. doi: 10.1007/s11121-024-01725-3. Online ahead of print.

  PMID: 39316242 DERIVED

MeSH Terms

Conditions

Depression; Self-Control

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Social Behavior

Results Point of Contact

• Title: Dr. Allison Caruthers
• Organization: University of Oregon Prevention Science Institute

ascaru@uoregon.edu

503-412-3770

Study Officials

• Elizabeth Stormshak, PhD

  University of Oregon

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 1, 2021
• First Posted: November 11, 2021
• Study Start: October 11, 2021
• Primary Completion: January 23, 2023
• Study Completion: January 23, 2023
• Last Updated: April 18, 2024
• Results First Posted: April 18, 2024

Record last verified: 2024-01

Locations

US (1)