ParentingFMSSNCT05400564
The Families and Middle School Success Project
A study testing Family Check-Up in people with Parenting and Parent-Child Relations, run by University of Oregon at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Parenting, Parent-Child Relations, Self-regulation
- What is being tested?
- Family Check-Up
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2022to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Oregon Prevention Science Institute
Portland, Oregon, 97209
About this study
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
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
- Being tested
- Family Check-Up
- Medical subject headings
- Self-Control, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Check-UpBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Family Check-Up |
| Control | No intervention | Parents in this arm will receive school support as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline in family conflict (parent and child report)
Measured with the CASEY
Measured: baseline, 3 months, 6 months, 12 months, 24 months
change from baseline in family relationships (parent and child report)
Measured with the CASEY
Measured: 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
Measured: 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
Measured: baseline, 3 months, 6 months, 12 months, 24 months
change from baseline in child's school grades (school report)
Obtained via school records
Measured: 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
Measured: baseline, 3 months, 6 months, 12 months, 24 months
change from baseline in child's school attendance (school report)
Obtained via school records
Measured: 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
Measured: 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
Measured: baseline, 3 months, 6 months, 12 months, 24 months
change from baseline in youth self regulation (parent, and child report)
Measured by the SDQ
Measured: 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
Measured: baseline, 3 months, 6 months, 12 months, 24 months
change from baseline in child's discipline referrals (school report)
Obtained via school records
Measured: baseline, 3 months, 6 months, 12 months, 24 months
Secondary outcomes (7)
change from baseline in parent depression and anxiety (parent report)
Measured by the PHQ-9
Measured: baseline, 3 months, 6 months, 12 months, 24 months
change from baseline in parental stress (parent report)
Measured by the PSS
Measured: baseline, 3 months, 6 months, 12 months, 24 months
change from baseline in youth depression (parent and child report)
Measured by the PHQ-9
Measured: baseline, 3 months, 6 months, 12 months, 24 months
change from baseline in parental sense of competency (parent report)
Measured by the PSOC
Measured: baseline, 3 months, 6 months, 12 months, 24 months
change from baseline in positive parenting behaviors (parent report)
Measured by the PCA
Measured: baseline, 3 months, 6 months, 12 months, 24 months
change from baseline in limit setting and supervision skills (parent report)
Measured by the PCA
Measured: baseline, 3 months, 6 months, 12 months, 24 months
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
Measured: baseline, 3 months, 6 months, 12 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start1 May 2022
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParentingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oregon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth Stormshak, Ph.D., Principal investigator, University of Oregon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05400564
- Sponsor's protocol ID
- STUDY00000404
- Acronym
- FMSS
- Status last verified
- Oct 2024
- First submitted
- 27 May 2022
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05400564
- Acronym / sponsor ID
- FMSS / STUDY00000404
- Conditions
- Parenting, Parent-Child Relations, Self-regulation, Problem Behavior in School, School Adjustment, Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of OregonUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 1 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| FCU Online + Coach | Experimental | Behavioral: Family Check-UpParents 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. |
| Control | No intervention | –Parents in this arm will receive school support as usual. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family Check-UpThis 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. | Behavioural | FCU Online + Coach |
Primary outcome
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 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 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 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 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's school attendance (school report)
Time frame: baseline, 3 months, 6 months, 12 months, 24 months
Obtained via school records
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 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 self regulation (parent, and child 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 child's discipline referrals (school report)
Time frame: baseline, 3 months, 6 months, 12 months, 24 months
Obtained via school records
7 secondary outcomes
change from baseline in parent depression and anxiety (parent report)
Time frame: baseline, 3 months, 6 months, 12 months, 24 months
change from baseline in parental stress (parent report)
Time frame: baseline, 3 months, 6 months, 12 months, 24 months
change from baseline in youth depression (parent and child report)
Time frame: baseline, 3 months, 6 months, 12 months, 24 months
change from baseline in parental sense of competency (parent report)
Time frame: baseline, 3 months, 6 months, 12 months, 24 months
change from baseline in positive parenting behaviors (parent report)
Time frame: baseline, 3 months, 6 months, 12 months, 24 months
change from baseline in limit setting and supervision skills (parent report)
Time frame: baseline, 3 months, 6 months, 12 months, 24 months
change from baseline in parenting involvement at school (parent report)
Time frame: baseline, 3 months, 6 months, 12 months, 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Stormshak, Ph.D. principal investigator
University of Oregon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Check-Up in people with Parenting and Parent-Child Relations, run by University of Oregon at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline in family conflict (parent and child report) (time frame: baseline, 3 months, 6 months, 12 months, 24 months). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.