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Active, Not Recruiting

NCT Number: NCT05400564

The Families and Middle School Success Project

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Parenting Behavior Behavioral Symptoms Depression Parent-Child Relations Problem Behavior in School School Adjustment 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 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

Treatment and study plan

Family Check-Up

Behavioral

This intervention includes access to the Family Check-Up app and telehealth coaching provided by trained mental health providers. Parents can contact their Coach as often as they like and a minimum of 3 coaching sessions will be scheduled.

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

Secondary outcomes

  1. change from baseline in parent depression and anxiety (parent report)

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

    Measured by the PHQ-9

  2. change from baseline in parental stress (parent report)

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

    Measured by the PSS

  3. change from baseline in youth depression (parent and child report)

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

    Measured by the PHQ-9

  4. change from baseline in parental sense of competency (parent report)

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

    Measured by the PSOC

  5. change from baseline in positive parenting behaviors (parent report)

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

    Measured by the PCA

  6. change from baseline in limit setting and supervision skills (parent report)

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

    Measured by the PCA

  7. change from baseline in parenting involvement at school (parent report)

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

    Measured by a modified version of the home-based learning factor of the FIQ-EC

Sponsors and collaborators

Lead sponsor

University of Oregon

Other

Registry information

Official study title

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

Acronym: FMSS

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jun 1, 2022
Registry last updated
Oct 15, 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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