The Families and Middle School Success Project

NCT05400564 | Active Not Recruiting

• 1 other identifier: STUDY00000404
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Parenting; Parent-Child Relations; Self-regulation; Problem Behavior in School; School Adjustment; Depression

Outcome Measures

Primary Outcomes (12)

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

  Measured with the CASEY

  baseline, 3 months, 6 months, 12 months, 24 months

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

  Measured with the CASEY

  baseline, 3 months, 6 months, 12 months, 24 months

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

  Measured with the SSRS

  baseline, 3 months, 6 months, 12 months, 24 months

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

  Measured with the school participation measure

  baseline, 3 months, 6 months, 12 months, 24 months

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

  Obtained via school records

  baseline, 3 months, 6 months, 12 months, 24 months

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

  Obtained via school records

  baseline, 3 months, 6 months, 12 months, 24 months

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

  Obtained via school records

  baseline, 3 months, 6 months, 12 months, 24 months

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

  Measured by the SDQ

  baseline, 3 months, 6 months, 12 months, 24 months

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

  Measured by the SDQ

  baseline, 3 months, 6 months, 12 months, 24 months

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

  Measured by the SDQ

  baseline, 3 months, 6 months, 12 months, 24 months

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

  Measured by the PASA

  baseline, 3 months, 6 months, 12 months, 24 months

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

  Obtained via school records

  baseline, 3 months, 6 months, 12 months, 24 months

Secondary Outcomes (7)

• 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 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 positive parenting behaviors (parent report)

  baseline, 3 months, 6 months, 12 months, 24 months

Study Arms (2)

FCU Online + Coach

EXPERIMENTAL

Parents in this arm will receive access to the FCU app and telehealth coaching/ support provided by a trained mental health provider. The FCU app 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

Control

NO INTERVENTION

Parents in this arm will receive school support as usual.

Interventions

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.

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 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).

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

Sponsors & Collaborators

• University of Oregon: lead

Study Sites (1)

University of Oregon Prevention Science Institute

Portland, Oregon, 97209, United States

Location

MeSH Terms

Conditions

Self-Control; Depression

Condition Hierarchy (Ancestors)

Social Behavior; Behavior; Behavioral Symptoms

Study Officials

• Elizabeth Stormshak, Ph.D.

  University of Oregon

  PRINCIPAL INVESTIGATOR

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. 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.

Study Record Dates

• First Submitted: May 27, 2022
• First Posted: June 1, 2022
• Study Start: May 1, 2022
• Primary Completion: March 31, 2025
• Study Completion: December 31, 2025
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will be shared at the end of the grant.
• Access Criteria: In order to access these data, the ICPSR Data Archive will require a data use agreement (DUA), which will provide for (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed. The data sharing agreement will also assure that the analysis being proposed is appropriate given the design and data available. This data will be shared with ICPSR and approved scientists without additional informed consent from the research participants.

Locations

US (1)