Clinical trial NCT05400564: The Families and Middle School Success Project
Official 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Parenting
Parent-Child Relations
Self-regulation
Problem Behavior in School
School Adjustment
Depression
Lead sponsor: University of Oregon
Sponsor class: OTHER
First posted: 2022-06-01
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Families will be assigned to treatment vs. a school as usual control. The investigators will assess families at baseline and at 3-, 6-, 12- and 24- month follow ups. Families in the treatment condition will receive the intervention between baseline and the 3-month follow-up.
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: change from baseline in family conflict (parent and child report)
timeFrame: baseline, 3 months, 6 months, 12 months, 24 months
measure: change from baseline in family relationships (parent and child report)
timeFrame: baseline, 3 months, 6 months, 12 months, 24 months
measure: change from baseline in child academic competence (parent, child and teacher report)
timeFrame: baseline, 3 months, 6 months, 12 months, 24 months
measure: change from baseline in child school engagement (parent, child and teacher report)
timeFrame: baseline, 3 months, 6 months, 12 months, 24 months
measure: change from baseline in child's school grades (school report)
timeFrame: baseline, 3 months, 6 months, 12 months, 24 months
measure: change from baseline in child's achievement test scores/school records/IEP (school report)
timeFrame: baseline, 3 months, 6 months, 12 months, 24 months
measure: change from baseline in child's school attendance (school report)
timeFrame: baseline, 3 months, 6 months, 12 months, 24 months
measure: change from baseline in youth emotional problems (parent, child and teacher report)
timeFrame: baseline, 3 months, 6 months, 12 months, 24 months
measure: change from baseline in youth behavior problems (parent, child and teacher report)
timeFrame: baseline, 3 months, 6 months, 12 months, 24 months
measure: change from baseline in youth self regulation (parent, and child report)
timeFrame: baseline, 3 months, 6 months, 12 months, 24 months
measure: change from baseline in youth social/peer relationships (parent and child report)
timeFrame: baseline, 3 months, 6 months, 12 months, 24 months
measure: change from baseline in child's discipline referrals (school report)
timeFrame: baseline, 3 months, 6 months, 12 months, 24 months
Secondary outcomes:
measure: change from baseline in parent depression and anxiety (parent report)
timeFrame: baseline, 3 months, 6 months, 12 months, 24 months
measure: change from baseline in parental stress (parent report)
timeFrame: baseline, 3 months, 6 months, 12 months, 24 months
measure: change from baseline in youth depression (parent and child report)
timeFrame: baseline, 3 months, 6 months, 12 months, 24 months
measure: change from baseline in parental sense of competency (parent report)
timeFrame: baseline, 3 months, 6 months, 12 months, 24 months
measure: change from baseline in positive parenting behaviors (parent report)
timeFrame: baseline, 3 months, 6 months, 12 months, 24 months
measure: change from baseline in limit setting and supervision skills (parent report)
timeFrame: baseline, 3 months, 6 months, 12 months, 24 months
measure: change from baseline in parenting involvement at school (parent report)
timeFrame: baseline, 3 months, 6 months, 12 months, 24 months
Other outcomes:
Locations:
city: Portland
country: United States
facility: University of Oregon Prevention Science Institute
state: Oregon
Study officials:
affiliation: University of Oregon
name: Elizabeth Stormshak, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: