Families of Middle School Students at Title 1 SchoolsFCONCT06161597
Family Check-Up Online
A study testing Family Check-Up Online in people with Families of Middle School Students at Title 1 Schools, run by Arizona State University at 1 site in United States.
Trial summary
The goal of this clinical trial is to test the benefits of the Family Check-Up Online Program for parents of middle school students in Arizona. Participants will complete an online pre-survey, gain access to the online parenting program Family Check-Up, and have the option to meet with a coach to discuss the program. Read more about this study
- Who is it for?
- Ages 10 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Families of Middle School Students at Title 1 Schools
- What is being tested?
- Family Check-Up Online
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2023to 30 Sep 2024
- 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 10 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All parents with a child enrolled in grades 6-8 at participating Title 1 public schools will be invited to take part in the study.
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Family Check-Up Online for Middle School Parents
The goal of this clinical trial is to test the benefits of the Family Check-Up Online Program for parents of middle school students in Arizona. Participants will complete an online pre-survey, gain access to the online parenting program Family Check-Up, and have the option to meet with a coach to discuss the program. The participants will also complete a post-survey 3 months after enrollment.
Read the detailed description
The lingering impact of the COVID-19 pandemic has impacted families adversely in multiple ways, including economic stressors, mental health-related functioning, and social/familial functioning. Given the scale of the pandemic's impact on families with school-aged children, the implementation of effective family-focused programs that target core mechanisms of change with a broad range of benefits for parents and youth across diverse populations, and that can be brought to scale rapidly and with fidelity, represents critical public health goals.
Toward this end, this project is designed to further examine the efficacy of a web-based version of the universal Family Check-Up prevention program, which is an empirically-supported, parent-focused program designed to promote resilience and improve family functioning among parents of middle school-aged youth (grades 6-8th). A randomized control trial conducted through the University of Oregon found that parents who completed the Family Check-up Online program (FCO) either with or without supplemental support coaching exhibited significant increases in confidence and effortful control related to implementing skills and strategies that promote positive emotional and behavioral health among teens. This suggests that parents who complete the program feel more empowered to help guide their child's positive decision making and more effectively manage family challenges.
This project will examine whether the FCO program produces improvements in positive parenting practices, reductions in parental emotional distress, and reductions in youth emotional/behavioral problems when delivered as a universal prevention program targeting parents of 6-8th grade students attending Title 1 public schools (>50% students eligible for free/reduced lunch). The investigators will also examine whether the structured parent coaching support component of the program (i.e., Guidance Coaching) helps to improve the program's effectiveness relative to a parent-initiated informational support condition.
- Being tested
- Family Check-Up Online
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Check-Up OnlineBehavioural
Families will be provided with access to the FCO program, available in English or Spanish. Parents complete a tutorial and five different modules focused on distinct parenting skills. Each module starts with a survey and feedback to help identify relative strengths and challenges with the targeted parenting skills. Parents are then guided through various online activities including videos that model right and wrong ways to handle comm on situations and explanations of parental self-management and problem-solving strategies. Parents are complete activities to practice the parenting skills taught. Parents will have access to the online program for 8 and they are encouraged to practice the program strategies during this time period. At the end of the 8 weeks, parent re-complete the brief questions that they filled out at the beginning of each module and then receive feedback indicating which of the parent's domain scores have improved since they completed each module.
| Study group | Role | What they receive |
|---|---|---|
| Informational Support | Experimental | Parents will be told that they have the option of contacting an informational support specialist any point while completing the program to address questions and discuss the program. Parents will be informed that their questions can be addressed via e-mail or alternatively they can schedule a time to talk with their coach via phone or Zoom. The informational support specialist will not initiate contact with parents in this condition. Receives: Behavioral: Family Check-Up Online |
| Guidance Coaching | Experimental | Parents will be informed that they have been assigned a guidance coach who will contact them via email to schedule 1-3 check-in meetings over the phone or via Zoom while they complete the online program. These meetings are structured to help establish parental goals for the program, offer emotional support, and help motivate parents to implement new parenting skills. During these contacts, coaches use motivational interviewing techniques to help promote and support behavioral change. These coaching contacts are designed to be brief and focused, and typically last for less than 30 minutes. Coach contacts are scheduled based on the parents' availability and interest, and additional coaching sessions can be requested by the parent at any point during the program. Receives: Behavioral: Family Check-Up Online |
What is being measured
The primary outcome is the main question the study is designed to answer.
Active Parental Monitoring
Parent self-report of monitoring, range 1-5, higher values = better outcome
Measured: 3 months
Positive Parenting
Parent self-report of positive parenting practices, range 1-5, higher values = better outcome
Measured: 3 months
Harsh Parenting
Parent self-report of harsh parenting, range 1-5, higher values = worse outcome
Measured: 3 months
Parental Confidence
Parent self-report of confidence with various parenting strategies, range 1-5, higher values = better outcome
Measured: 3 months
Child Anger
Parent report of their child's anger, range 1-5, higher values = worse outcome
Measured: 3 months
Child Oppositional Defiance
Parent report of their child's oppositional defiant behavior, range 1-5, higher values = worse outcome
Measured: 3 months
Child Callous-Unemotional Traits
Parent report of their child's callousness, range 1-5, higher values = worse outcome
Measured: 3 months
Child Aggression
Parent report of their child's aggression, range 1-5, higher values = worse outcome
Measured: 3 months
Child School Performance
Parent report of their child's school performance, range 1-5, higher values = better outcome
Measured: 3 months
Child Stress
Parent report of child's stress with PROMIS scale, range 1-5, higher values = worse outcome
Measured: 3 months
Child Anxiety
Parent report of child's anxiety with PROMIS scale, range 1-5, higher values = worse outcome
Measured: 3 months
Child Depression
Parent report of child's depression with PROMIS scale, range 1-5, higher values = worse outcome
Measured: 3 months
Family Conflict
Parent report of family conflict including arguing and fighting, range 1-5, higher values = worse outcomes
Measured: 3 months
Secondary outcomes (3)
Parent Anxiety
Parent self-report of anxiety with PROMIS scale, range 1-5, higher values = worse outcome
Measured: 3 months
Parent Depression
Parent self-report of depression with PROMIS scale, range 1-5, higher values = worse outcome
Measured: 3 months
Parent Stress
Parent self-report of stress with PROMIS scale, range 1-5, higher values = worse outcome
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start25 Oct 2023
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Families of Middle School Students at Title 1 SchoolsStudies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe sponsor's other registered studies.
- 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
- All participants will receive the primary intervention: The Family Check-Up Online. Participants will then be randomly assigned to a specific coaching condition.
- Masking
- None (open label)
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Collaborators
- Arizona Health Care Cost Containment System
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06161597
- Sponsor's protocol ID
- STUDY00017956
- Acronym
- FCO
- Status last verified
- Jul 2026
- First submitted
- 22 Nov 2023
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Check-Up Online for Middle School Parents
- ClinicalTrials.gov ID
- NCT06161597
- Acronym / sponsor ID
- FCO / STUDY00017956
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Collaborators
- Arizona Health Care Cost Containment System
- Study start
- 25 Oct 2023 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 8 Dec 2023 (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 goal of this clinical trial is to test the benefits of the Family Check-Up Online Program for parents of middle school students in Arizona. Participants will complete an online pre-survey, gain access to the online parenting program Family Check-Up, and have the option to meet with a coach to discuss the program. The participants will also complete a post-survey 3 months after enrollment.
Detailed description
The lingering impact of the COVID-19 pandemic has impacted families adversely in multiple ways, including economic stressors, mental health-related functioning, and social/familial functioning. Given the scale of the pandemic's impact on families with school-aged children, the implementation of effective family-focused programs that target core mechanisms of change with a broad range of benefits for parents and youth across diverse populations, and that can be brought to scale rapidly and with fidelity, represents critical public health goals.
Toward this end, this project is designed to further examine the efficacy of a web-based version of the universal Family Check-Up prevention program, which is an empirically-supported, parent-focused program designed to promote resilience and improve family functioning among parents of middle school-aged youth (grades 6-8th). A randomized control trial conducted through the University of Oregon found that parents who completed the Family Check-up Online program (FCO) either with or without supplemental support coaching exhibited significant increases in confidence and effortful control related to implementing skills and strategies that promote positive emotional and behavioral health among teens. This suggests that parents who complete the program feel more empowered to help guide their child's positive decision making and more effectively manage family challenges.
This project will examine whether the FCO program produces improvements in positive parenting practices, reductions in parental emotional distress, and reductions in youth emotional/behavioral problems when delivered as a universal prevention program targeting parents of 6-8th grade students attending Title 1 public schools (>50% students eligible for free/reduced lunch). The investigators will also examine whether the structured parent coaching support component of the program (i.e., Guidance Coaching) helps to improve the program's effectiveness relative to a parent-initiated informational support condition.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All participants will receive the primary intervention: The Family Check-Up Online. Participants will then be randomly assigned to a specific coaching condition.
| Arm | Type | Receives |
|---|---|---|
| Informational Support | Experimental | Behavioral: Family Check-Up OnlineParents will be told that they have the option of contacting an informational support specialist any point while completing the program to address questions and discuss the program. Parents will be informed that their questions can be addressed via e-mail or alternatively they can schedule a time to talk with their coach via phone or Zoom. The informational support specialist will not initiate contact with parents in this condition. |
| Guidance Coaching | Experimental | Behavioral: Family Check-Up OnlineParents will be informed that they have been assigned a guidance coach who will contact them via email to schedule 1-3 check-in meetings over the phone or via Zoom while they complete the online program. These meetings are structured to help establish parental goals for the program, offer emotional support, and help motivate parents to implement new parenting skills. During these contacts, coaches use motivational interviewing techniques to help promote and support behavioral change. These coaching contacts are designed to be brief and focused, and typically last for less than 30 minutes. Coach contacts are scheduled based on the parents' availability and interest, and additional coaching sessions can be requested by the parent at any point during the program. |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All parents with a child enrolled in grades 6-8 at participating Title 1 public schools will be invited to take part in the study.
Key exclusion criteria (1 listed)
- N/A
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-Up OnlineFamilies will be provided with access to the FCO program, available in English or Spanish. Parents complete a tutorial and five different modules focused on distinct parenting skills. Each module starts with a survey and feedback to help identify relative strengths and challenges with the targeted parenting skills. Parents are then guided through various online activities including videos that model right and wrong ways to handle comm on situations and explanations of parental self-management and problem-solving strategies. Parents are complete activities to practice the parenting skills taught. Parents will have access to the online program for 8 and they are encouraged to practice the program strategies during this time period. At the end of the 8 weeks, parent re-complete the brief questions that they filled out at the beginning of each module and then receive feedback indicating which of the parent's domain scores have improved since they completed each module. | Behavioural | Guidance Coaching, Informational Support |
Primary outcome
Active Parental Monitoring
Time frame: 3 months
Parent self-report of monitoring, range 1-5, higher values = better outcome
Positive Parenting
Time frame: 3 months
Parent self-report of positive parenting practices, range 1-5, higher values = better outcome
Harsh Parenting
Time frame: 3 months
Parent self-report of harsh parenting, range 1-5, higher values = worse outcome
Parental Confidence
Time frame: 3 months
Parent self-report of confidence with various parenting strategies, range 1-5, higher values = better outcome
Child Anger
Time frame: 3 months
Parent report of their child's anger, range 1-5, higher values = worse outcome
Child Oppositional Defiance
Time frame: 3 months
Parent report of their child's oppositional defiant behavior, range 1-5, higher values = worse outcome
Child Callous-Unemotional Traits
Time frame: 3 months
Parent report of their child's callousness, range 1-5, higher values = worse outcome
Child Aggression
Time frame: 3 months
Parent report of their child's aggression, range 1-5, higher values = worse outcome
Child School Performance
Time frame: 3 months
Parent report of their child's school performance, range 1-5, higher values = better outcome
Child Stress
Time frame: 3 months
Parent report of child's stress with PROMIS scale, range 1-5, higher values = worse outcome
Child Anxiety
Time frame: 3 months
Parent report of child's anxiety with PROMIS scale, range 1-5, higher values = worse outcome
Child Depression
Time frame: 3 months
Parent report of child's depression with PROMIS scale, range 1-5, higher values = worse outcome
Family Conflict
Time frame: 3 months
Parent report of family conflict including arguing and fighting, range 1-5, higher values = worse outcomes
3 secondary outcomes
Parent Anxiety
Time frame: 3 months
Parent Depression
Time frame: 3 months
Parent Stress
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Online in people with Families of Middle School Students at Title 1 Schools, run by Arizona State University 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 20 Jul 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Active Parental Monitoring (time frame: 3 months). The study lists 13 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 20 Jul 2026.