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Clinical Trials/NCT05400564
NCT05400564
Active, not recruiting
Not Applicable

Preventing Emotional and Behavioral Problems in Middle School Youth At-risk of Disability After the Covid-19 Pandemic With the Family Check-up Online

University of Oregon1 site in 1 country300 target enrollmentStarted: May 1, 2022Last updated:

Overview

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
300
Locations
1
Primary Endpoint
change from baseline in child's school grades (school report)

Overview

Brief Summary

The purpose of the proposed research is to conduct an efficacy trial of the Family Check-Up (FCU) Online to prevent emotional and behavioral disorders among middle-school students at-risk for disability during the transition back to school after the COVID-19 pandemic. Mental health and behavior problems are at epidemic proportions as a result of the COVID-19 pandemic, with the highest rates in adolescents and children with disabilities. We propose to evaluate the efficacy of the FCU Online, a school-based, ecological approach to family intervention and risk reduction, across a group of students at-risk or identified with disability during the middle school years. The FCU Online for middle school youth has been evaluated in a randomized trial in prior research during the development of the program but has never been tested as a large-scale, school-based intervention or delivered by providers working in schools. It has recently been adapted for COVID-19 and includes new modules on coping with stress and home-to-school engagement to support the return to school after COVID-19 for students at-risk. Students in schools will be identified for services using indicators that are natural to the school environment (attendance, office discipline referrals, and grades), and will be followed for 2 years. We predict that engagement in the FCU Online will be associated with student reductions in emotional and behavior problems, improvements in academic skills, and improvements in attendance. Parenting skills such as home-to-school communication, positive parenting, and behavioral routines will be tested as mediators of intervention efficacy.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • A caregiver must have a child between the ages of 11 and 14
  • The child must be a middle school student enrolled at a participating middle school including: Alder Creek Middle School in Milwaukee, Oregon, or Wilbur Rowe Middle School in Milwaukee, Oregon
  • 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
  • The student must have one or more of the following risk factors: 1) two or more office discipline referrals; 2) grades below a 2.5 GPA; 3) poor attendance, i.e., missing more than 10% of school days; 4) IEP for emotional disturbance or related disabilities; or 5) concerns about the child on the behavioral and mental health screener (as indicated by a score of 3 on any one item, or a score of 2 or higher on at least two items).

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
  • The family is already participating in another study of the University of Oregon's Prevention Science Institute

Outcomes

Primary Outcomes

change from baseline in child's school grades (school report)

Time Frame: baseline, 3 months, 6 months, 12 months, 24 months

Obtained via school records

change from baseline in child's school attendance (school report)

Time Frame: baseline, 3 months, 6 months, 12 months, 24 months

Obtained via school records

change from baseline in family conflict (parent and child report)

Time Frame: baseline, 3 months, 6 months, 12 months, 24 months

Measured with the CASEY

change from baseline in family relationships (parent and child report)

Time Frame: baseline, 3 months, 6 months, 12 months, 24 months

Measured with the CASEY

change from baseline in child's achievement test scores/school records/IEP (school report)

Time Frame: baseline, 3 months, 6 months, 12 months, 24 months

Obtained via school records

change from baseline in child school engagement (parent, child and teacher report)

Time Frame: baseline, 3 months, 6 months, 12 months, 24 months

Measured with the school participation measure

change from baseline in child's discipline referrals (school report)

Time Frame: baseline, 3 months, 6 months, 12 months, 24 months

Obtained via school records

change from baseline in child academic competence (parent, child and teacher report)

Time Frame: baseline, 3 months, 6 months, 12 months, 24 months

Measured with the SSRS

change from baseline in youth behavior problems (parent, child and teacher report)

Time Frame: baseline, 3 months, 6 months, 12 months, 24 months

Measured by the SDQ

change from baseline in youth social/peer relationships (parent and child report)

Time Frame: baseline, 3 months, 6 months, 12 months, 24 months

Measured by the PASA

change from baseline in youth emotional problems (parent, child and teacher report)

Time Frame: baseline, 3 months, 6 months, 12 months, 24 months

Measured by the SDQ

change from baseline in youth self regulation (parent, and child report)

Time Frame: baseline, 3 months, 6 months, 12 months, 24 months

Measured by the SDQ

Secondary Outcomes

  • change from baseline in youth depression (parent and child report)(baseline, 3 months, 6 months, 12 months, 24 months)
  • change from baseline in parental sense of competency (parent report)(baseline, 3 months, 6 months, 12 months, 24 months)
  • change from baseline in limit setting and supervision skills (parent report)(baseline, 3 months, 6 months, 12 months, 24 months)
  • change from baseline in parent depression and anxiety (parent report)(baseline, 3 months, 6 months, 12 months, 24 months)
  • change from baseline in parental stress (parent report)(baseline, 3 months, 6 months, 12 months, 24 months)
  • change from baseline in positive parenting behaviors (parent report)(baseline, 3 months, 6 months, 12 months, 24 months)
  • change from baseline in parenting involvement at school (parent report)(baseline, 3 months, 6 months, 12 months, 24 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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