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The Families and Middle School Success Project (FMSS)

Primary Purpose

Parenting, Parent-Child Relations, Self-regulation

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Family Check-Up
Sponsored by
University of Oregon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Parenting

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Oregon Prevention Science InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

FCU Online + Coach

Control

Arm Description

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.

Parents in this arm will receive school support as usual.

Outcomes

Primary Outcome Measures

change from baseline in family conflict (parent and child report)
Measured with the CASEY
change from baseline in family relationships (parent and child report)
Measured with the CASEY
change from baseline in child academic competence (parent, child and teacher report)
Measured with the SSRS
change from baseline in child school engagement (parent, child and teacher report)
Measured with the school participation measure
change from baseline in child's school grades (school report)
Obtained via school records
change from baseline in child's achievement test scores/school records/IEP (school report)
Obtained via school records
change from baseline in child's school attendance (school report)
Obtained via school records
change from baseline in youth emotional problems (parent, child and teacher report)
Measured by the SDQ
change from baseline in youth behavior problems (parent, child and teacher report)
Measured by the SDQ
change from baseline in youth self regulation (parent, and child report)
Measured by the SDQ
change from baseline in youth social/peer relationships (parent and child report)
Measured by the PASA
change from baseline in child's discipline referrals (school report)
Obtained via school records

Secondary Outcome Measures

change from baseline in parent depression and anxiety (parent report)
Measured by the PHQ-9
change from baseline in parental stress (parent report)
Measured by the PSS
change from baseline in youth depression (parent and child report)
Measured by the PHQ-9
change from baseline in parental sense of competency (parent report)
Measured by the PSOC
change from baseline in positive parenting behaviors (parent report)
Measured by the PCA
change from baseline in limit setting and supervision skills (parent report)
Measured by the PCA
change from baseline in parenting involvement at school (parent report)
Measured by a modified version of the home-based learning factor of the FIQ-EC

Full Information

First Posted
May 27, 2022
Last Updated
August 24, 2023
Sponsor
University of Oregon
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1. Study Identification

Unique Protocol Identification Number
NCT05400564
Brief Title
The Families and Middle School Success Project
Acronym
FMSS
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
March 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oregon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parenting, Parent-Child Relations, Self-regulation, Problem Behavior in School, School Adjustment, Depression

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FCU Online + Coach
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Parents in this arm will receive school support as usual.
Intervention Type
Behavioral
Intervention Name(s)
Family Check-Up
Intervention Description
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 Outcome Measure Information:
Title
change from baseline in family conflict (parent and child report)
Description
Measured with the CASEY
Time Frame
baseline, 3 months, 6 months, 12 months, 24 months
Title
change from baseline in family relationships (parent and child report)
Description
Measured with the CASEY
Time Frame
baseline, 3 months, 6 months, 12 months, 24 months
Title
change from baseline in child academic competence (parent, child and teacher report)
Description
Measured with the SSRS
Time Frame
baseline, 3 months, 6 months, 12 months, 24 months
Title
change from baseline in child school engagement (parent, child and teacher report)
Description
Measured with the school participation measure
Time Frame
baseline, 3 months, 6 months, 12 months, 24 months
Title
change from baseline in child's school grades (school report)
Description
Obtained via school records
Time Frame
baseline, 3 months, 6 months, 12 months, 24 months
Title
change from baseline in child's achievement test scores/school records/IEP (school report)
Description
Obtained via school records
Time Frame
baseline, 3 months, 6 months, 12 months, 24 months
Title
change from baseline in child's school attendance (school report)
Description
Obtained via school records
Time Frame
baseline, 3 months, 6 months, 12 months, 24 months
Title
change from baseline in youth emotional problems (parent, child and teacher report)
Description
Measured by the SDQ
Time Frame
baseline, 3 months, 6 months, 12 months, 24 months
Title
change from baseline in youth behavior problems (parent, child and teacher report)
Description
Measured by the SDQ
Time Frame
baseline, 3 months, 6 months, 12 months, 24 months
Title
change from baseline in youth self regulation (parent, and child report)
Description
Measured by the SDQ
Time Frame
baseline, 3 months, 6 months, 12 months, 24 months
Title
change from baseline in youth social/peer relationships (parent and child report)
Description
Measured by the PASA
Time Frame
baseline, 3 months, 6 months, 12 months, 24 months
Title
change from baseline in child's discipline referrals (school report)
Description
Obtained via school records
Time Frame
baseline, 3 months, 6 months, 12 months, 24 months
Secondary Outcome Measure Information:
Title
change from baseline in parent depression and anxiety (parent report)
Description
Measured by the PHQ-9
Time Frame
baseline, 3 months, 6 months, 12 months, 24 months
Title
change from baseline in parental stress (parent report)
Description
Measured by the PSS
Time Frame
baseline, 3 months, 6 months, 12 months, 24 months
Title
change from baseline in youth depression (parent and child report)
Description
Measured by the PHQ-9
Time Frame
baseline, 3 months, 6 months, 12 months, 24 months
Title
change from baseline in parental sense of competency (parent report)
Description
Measured by the PSOC
Time Frame
baseline, 3 months, 6 months, 12 months, 24 months
Title
change from baseline in positive parenting behaviors (parent report)
Description
Measured by the PCA
Time Frame
baseline, 3 months, 6 months, 12 months, 24 months
Title
change from baseline in limit setting and supervision skills (parent report)
Description
Measured by the PCA
Time Frame
baseline, 3 months, 6 months, 12 months, 24 months
Title
change from baseline in parenting involvement at school (parent report)
Description
Measured by a modified version of the home-based learning factor of the FIQ-EC
Time Frame
baseline, 3 months, 6 months, 12 months, 24 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Allison Caruthers, Ph.D.
Phone
503-412-3770
Email
ascaru@uoregon.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Stormshak, Ph.D.
Organizational Affiliation
University of Oregon
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Oregon Prevention Science Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97209
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Assessment Coordinator (English)
Phone
971-219-2025
Email
msparenting@uoregon.edu
First Name & Middle Initial & Last Name & Degree
Assessment Coordinator (Spanish)
Phone
971-645-3516
Email
crianza@uoregon.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Per the terms of the funding contract from IES, de-identified study data will eventually be deposited at a public repository, Inter-university Consortium for Political and Social Research (ICPSR), to increase its utility to qualified individuals within the scientific community. Direct requests for data from other researchers and the public will be also considered, and data will be made available in accordance with local institution policies, IRB recommendations, local/state/federal laws and regulations, and considerations for publication. Any applicable data sharing will follow HIPAA rules.
IPD Sharing Time Frame
Data will be shared at the end of the grant.
IPD Sharing 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.
IPD Sharing URL
https://www.icpsr.umich.edu/

Learn more about this trial

The Families and Middle School Success Project

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