School AttendanceNCT07264621
The University of Oregon ACCESS Project
A study testing Inclusive Skill-building Learning Approach (ISLA), Family Check-Up Online (FCU-O) and FCU-Online with telehealth coaching in people with School Attendance and School Climate, run by University of Oregon at 13 sites in United States.
Trial summary
The goal of this clinical trial is to learn if two behavioral interventions work to reduce office disciplinary referrals, improve attendance, and reduce depression and anxiety in 7th grade students. Read more about this study
- Who is it for?
- Ages 11 years and olderHealthy volunteers can take part
- Conditions the study is for
- School Attendance, School Climate, School Engagement
- What is being tested?
- Inclusive Skill-building Learning Approach (ISLA), Family Check-Up Online (FCU-O) and FCU-Online with telehealth coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,440 participants
- Where
- 13 sitesUnited States
- Study dates
- 13 Aug 2025to 31 Mar 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 11 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
School Inclusion Criteria:
- The middle school must be located in Oregon and serve a population with high levels of NIH-defined health disparity; and
- The middle school must have a history of collaboration with the National PBIS Technical Assistance Center or the Northwest PBIS network.
School Staff Inclusion Criteria:
- School staff must be employed by a participating middle school; and
- School staff must be willing and interested in receiving training and support throughout implementation
Family Inclusion Criteria:
- The target child must attend a middle school which has been randomly assigned to receive the ISLA intervention or School-as-Usual;
- The target child must be in 7th grade and between the ages of 11 and 14;
- The caregiver must be the parent or legal guardian of the target child;
- The target child must exhibit at least one of the following risk factors during the prior academic year (6th grade):
- 2 or more office discipline referrals;
- poor attendance, i.e., missing 2 more school days per month; and
- The caregiver must have a smartphone with text messaging capability, access to email and internet.
Family Exclusion Criteria:
Families will be excluded from the study if:
- the caregiver is unable to read in either English or Spanish;
- either member of the parent-child dyad chooses not to participate (i.e., both members of the dyad need to consent/ assent); or
- the family is already participating in another study at the University of Oregon's Prevention Science Institute.
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
United States13 sites
Lincoln Middle School
Cottage Grove, Oregon, 97424
Monroe Middle School
Eugene, Oregon, 97401
Kelly Middle School
Eugene, Oregon, 97404
Madison Middle School
Eugene, Oregon, 97404
Arts & Technology Academy
Eugene, Oregon, 97405
Kennedy Middle School
Eugene, Oregon, 97405
Roosevelt Middle School
Eugene, Oregon, 97405
Spencer Butte Middle School
Eugene, Oregon, 97405
Cal Young Middle School
Eugene, Oregon, 97408
Briggs Middle School
Springfield, Oregon, 97477
Hamlin Middle School
Springfield, Oregon, 97477
Agnes Stewart Middle School
Springfield, Oregon, 97478
Thurston Middle School
Springfield, Oregon, 97478
About this study
Official title: Adaptive Multi-tiered School-based Prevention to Promote Youth Mental Health and Create Equitable and Sustainable Systems of Care
The goal of this clinical trial is to learn if two behavioral interventions work to reduce office disciplinary referrals, improve attendance, and reduce depression and anxiety in 7th grade students. This project combines two evidence-based programs-the Inclusive Skill-building Learning Approach (ISLA) for school-wide discipline reform and the Family Check-Up Online (FCU-O) for family-centered support-in an adaptive design to examine the unique and additive effects of these interventions on these child behavior outcomes.
The main questions it will answer are:
Read more
- What is the relative efficacy of ISLA vs. School-as-Usual?
- What is the optimal sequencing of these interventions?
- Which overall sequence of intervention strategies was most effective?
Researchers will compare 6 combinations of these interventions to see which combination and sequencing provides the best student outcomes.
School personnel participating in the project will be trained to implement the two interventions at their school. They will answer surveys in the fall, winter, and spring of their year of participation. Parent and Youth participants will complete surveys at baseline and then again 6 months and 12 months later.
Read the detailed description
In the past decade, youth mental health and behavior concerns have been some of the most significant challenges in schools, exacerbated by the COVID-19 pandemic. A high percentage of adolescents experience mental health distress, but only a fraction of them recieve adequate services, especially in underserved communities. School-based services face barriers such as limited funding, staffing shortages, and a lack of evidence-based programming. Mental health issues are driven by a combination of individual and systemic risk factors, including inequitable school policies, caregiver stress, and family history of mental health disorders. Youth from minoritized backgrounds face higher stressors, further impacting their mental health. Due to the complexity and depth of these issues, an approach that intervenes on a school- and family-level could show significant reduction in mental health and behavioral concerns which would otherwise precipitate into a lifetime of cascading negative outcomes.
Effective strategies that can aid in this youth mental health epidemic include family-centered treatments and school-wide programs to reduce exclusionary discipline practices, which disproportionately affect marginalized students and contribute to the school-to-prison pipeline. Family engagement in mental health interventions has shown positive, long-term effects, but participation rates remain low, with most school programs focusing on individual students rather than families.
This project aims to highlight the importance of embedding mental health services in schools by way of providing schools with equitable skill-building supports to improve student social and behavioral problem-solving, as well as providing families with a brief, strengths-based, digital health intervention for families to reduce mental health and behavioral concerns by improving emotional regulation and family relationships. Digital health interventions, like web-based programs, offer a promising solution to reach underserved families and students. This project combines two evidence-based programs-the Inclusive Skill-building Learning Approach (ISLA) for school-wide discipline reform and the Family Check-Up Online (FCU-O) for family-centered support-in an adaptive design. Integrating a family-centered intervention that promotes positive and nurturing familial relationships with a systemic intervention that addresses inequitable discipline practices in schools provides a promising and innovative approach for reducing the youth mental health crisis across multiple systems, including home, school, and communities. This approach aims to reduce mental health issues by addressing both school and family dynamics. The project evaluates the effectiveness and sustainability of these interventions using a multi-level model and randomized trials.
- Conditions
- School Attendance, School Climate, School Engagement, School Exclusion, Externalizing Behavior, Disparities
- Being tested
- Inclusive Skill-building Learning Approach (ISLA), Family Check-Up Online (FCU-O), FCU-Online with telehealth coaching
- Keywords
- school-based intervention, family intervention, middle school, SMART trial
- Medical subject headings
- Emotional Regulation, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inclusive Skill-building Learning Approach (ISLA)Behavioural
ISLA is a school-wide, multi-component, instructional and restorative alternative to exclusionary discipline that involves universal prevention grounded in positive, preventative classroom strategies for all students, and layers on additional supports for students in need.Derived from the original School-Wide Positive Behavioral Interventions model (SWPBIS) with roots in social learning theory, ISLA emphasizes that behavior is learned through modeling and teaching, and that environmental factors and the quality of teaching practices influence when and how a behavior is likely to occur. The ISLA model emphasizes ongoing training and coaching of classroom-level prevention strategies and practices that teachers use to promote building strong relationships, preventing school disconnectedness, and improving instructional and restorative alternatives to exclusion.
Family Check-Up Online (FCU-O)Behavioural
The Family Check-Up Online is a digital intervention that includes an assessment, computer-generated feedback, and intervention modules that focus on improving family relationships and parenting skills in order to reduce child mental health problems and to improve child self-regulation. These modules include Healthy Behaviors for Stressful Times, Positive Parenting, Rules and Consequences, Supporting School Success, and Communication.
FCU-Online with telehealth coachingBehavioural
This intervention is the Family Check-Up Online plus telehealth support from a parenting coach. The Family Check-Up Online is a digital intervention that includes an assessment, computer-generated feedback, and intervention modules that focus on improving family relationships and parenting skills in order to reduce child mental health problems and to improve child self-regulation. These modules include Healthy Behaviors for Stressful Times, Positive Parenting, Rules and Consequences, Supporting School Success, and Communication. A coach based at the child's school meets with caregivers via telehealth modality to provide motivation and to help caregivers tailor the content of the modules to their specific child and family's needs.
| Study group | Role | What they receive |
|---|---|---|
| School-As-Usual (SAU) Only | No intervention | Students were selected to participate in the study based on meeting attendance and behavioral criteria in 6th grade for Tier 2 or Tier 3 school supports. Students in this arm attended 7th grade at a school in the School-As-Usual condition and therefore did not receive the Tier 1 intervention, ISLA. In addition, in January of 7th grade their school behavior and attendance no longer met criteria for assignment to the Tier 2 intervention, the Family Check-up Online. Thus, students in this arm received neither the ISLA nor FCU-O interventions. |
| SAU + FCU Online Only | Experimental | Students were selected to participate in the study based on meeting attendance and behavioral criteria in 6th grade for Tier 2 or Tier 3 school supports. Students in this arm attended 7th grade at a school in the School-As-Usual condition and therefore did not receive the Tier 1 intervention, ISLA. In January of 7th grade their school behavior and attendance continued to meet criteria for assignment to Tier 2 intervention, and thus they received the Family Check-Up Online. In this arm, students' parents were assigned to receive the Family Check-Up Online digital intervention only (without supportive telehealth coaching). Receives: Behavioral: Family Check-Up Online (FCU-O) |
| SAU + FCU Online with Telehealth Coaching | Experimental | Students were selected to participate in the study based on meeting attendance and behavioral criteria in 6th grade for Tier 2 or Tier 3 school supports. Students in this arm attended 7th grade at a school in the SAU condition, and therefore did not receive the Tier 1 intervention, ISLA. In January of 7th grade their school behavior and attendance continued to meet criteria for Tier 2 intervention, and thus they received the Family Check-Up Online. In this arm, students' parents were assigned to receive the Family Check-Up Online digital intervention and telehealth coaching to support uptake of FCU content. Receives: Behavioral: FCU-Online with telehealth coaching |
| ISLA intervention + FCU Online Only | Experimental | Students were selected to participate in the study based on meeting attendance and behavioral criteria in 6th grade for Tier 2 or Tier 3 school supports. Students in this arm attended 7th grade at a school which implemented the school-wide Tier 1 intervention, ISLA. In January of 7th grade their school behavior and attendance continued to meet criteria for Tier 2 intervention, and thus they received the Family Check-Up Online. In this arm, students' parents were assigned to receive the Family Check-Up Online digital intervention only (without supportive telehealth coaching). Receives: Behavioral: Inclusive Skill-building Learning Approach (ISLA); Behavioral: Family Check-Up Online (FCU-O) |
| ISLA intervention+ FCU Online with Telehealth Coaching | Experimental | Students were selected to participate in the study based on meeting attendance and behavioral criteria in 6th grade for Tier 2 or Tier 3 school supports. Students in this arm attended a school which implemented the school-wide Tier 1 intervention, ISLA. In January of 7th grade their school behavior and attendance continued to meet criteria for Tier 2 intervention, and thus they received the Family Check-Up Online. In this arm, students' parents were assigned to receive the Family Check-Up Online digital intervention with telehealth coaching to support uptake of the FCU content. Receives: Behavioral: Inclusive Skill-building Learning Approach (ISLA); Behavioral: FCU-Online with telehealth coaching |
| ISLA Intervention Only | Experimental | Students were selected to participate in the study based on meeting attendance and behavioral criteria in 6th grade for Tier 2 or Tier 3 school supports. Students in this arm attended a school which implemented the school-wide Tier 1 intervention, ISLA. In January of 7th grade their attendance and behavior no longer met criteria for Tier 2 intervention. Thus, their parents were not offered the FCU Online digital intervention. Receives: Behavioral: Inclusive Skill-building Learning Approach (ISLA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Child Depression (Parent Report)
Parents report on their child's depression using the eight item PHQ-8. Parents are asked to indicate how often their child has experienced symptoms over the last two weeks using a 4-pt Likert scale: 0 =not at all, 1=several days, 2=more than half the days, 3= nearly every day. Scores for individual items are summed together. Higher scores indicate greater child depression.
Measured: baseline, 6 months, 12 months
Change from Baseline in Child Depression (Student Report)
Students report on their symptoms of depression using the eight item PHQ-8. Students are asked to indicate how often they have experienced symptoms over the last two weeks using a 4-pt Likert scale: 0 =not at all, 1=several days, 2=more than half the days, 3= nearly every day. Scores for individual items are summed together. Higher scores indicate greater child depression.
Measured: baseline, 6 months, 12 months
Change from Baseline in Child Anxiety (Parent Report)
Parents report on their child's anxiety using the 7 item GAD-7. Parents are asked to indicate how often their child has experienced symptoms over the past 2 weeks using a 4-pt Likert scale: 0= not at all, 1=several days, 2=more than half the days, and 3= nearly every day. Ratings of the 7 items are summed together. Higher scores indicate greater child anxiety.
Measured: baseline, 6 months, 12 months
Change from Baseline in Child Anxiety (Student Report)
Students report on their symptoms of anxiety using the 7 item GAD-7. Students are asked to indicate how often they have experienced symptoms over the past 2 weeks using a 4-pt Likert scale: 0= not at all, 1=several days, 2=more than half the days, and 3= nearly every day. Ratings of the 7 items are summed together. Higher scores indicate greater child anxiety.
Measured: baseline, 6 months, 12 months
Change from Baseline in Student Problem Behaviors (Parent Report)
The Strengths and Difficulties Questionnaire (SDQ; Goodman 1997) is a 25-item behavioral screening questionnaire about psychosocial problems for youth, and includes competencies or strengths in addition to assessing problems. The SDQ is equally divided across five scales measuring emotional symptoms, conduct problems, hyperactivity-inattention, peer problems, and prosocial behavior. Parents are provided statements and asked to indicate how true each statement has been for their child over the past 6 months using a 3-pt Likert scale: 0=Not True, 1=Somewhat True, and 2=Certainly True. Ratings are summed, and higher scores indicate more problem behavior.
Measured: baseline, 6 months, 12 months
Change from Baseline in Student Problem Behaviors (Student Report)
The Strengths and Difficulties Questionnaire (SDQ; Goodman 1997) is a 25-item behavioral screening questionnaire about psychosocial problems for youth, and includes competencies or strengths in addition to assessing problems. The SDQ is equally divided across five scales measuring emotional symptoms, conduct problems, hyperactivity-inattention, peer problems, and prosocial behavior. Students are provided statements and asked to indicate how true each statement has been for them over the past 6 months using a 3-pt Likert scale: 0=Not True, 1=Somewhat True, and 2=Certainly True. Ratings are summed, and higher scores indicate more problem behavior.
Measured: baseline, 6 months, 12 months
Change from Baseline in School Climate (Student Report)
The School Climate Survey: Secondary (SCS-S) is a 36-item school climate rating scale (Center on PBIS, 2022) intended to obtain middle and high school student perception ratings of school climate. It has 8 subscales: school connectedness, peer social support, adult social support, cultural acceptance, social/ civic learning, physical environment, school safety, and order and discipline. Respondents use a 4-point Likert scale: 1=Strongly Disagree, 2 = Somewhat Disagree, 3 = Somewhat Agree, and 4 = Strongly Agree. To compute the overall school climate score, item responses are summed and then divided by the total number of items. Higher overall scores reflect a more positive sense of the school environment.
Measured: baseline, 6 months, 12 months
Change from Baseline in School Climate (Teacher Report)
The School Climate Survey: School Personnel (Center on PBIS, 2022) includes 29 items and 5 subscales, including staff connectedness, structure for learning, school safety, physical environment, peer and adult relations, and parent involvement. School personnel rate items with a four-point Likert scale: 1=Strongly Disagree, 2=Somewhat Disagree, 3=Somewhat Agree, and 4=Strongly Agree. To compute the overall school climate score, item responses are summed and then divided by the total number of items. Higher overall scores reflect a more positive sense of the school environment.
Measured: Fall, Winter, and Spring of one academic year (e.g., baseline, 6 months, 10 months)
Change from Baseline in Number of ODRs, In-School Suspensions, and Out-of-School Suspensions (School-Level)
The number of office disciplinary referrals (ODRs), in-school (ISS), and out-of-school suspensions (OSS) will be gleaned from school records and aggregated at the school-level.
Measured: Fall, winter, and spring of two academic years (baseline, 6 months, 9 months, 12 months, 18 months, 21 months)
Change from Baseline in Number of ODRs, In-School Suspensions, and Out-of-School Suspensions (Student-Level)
The number of office disciplinary referrals (ODRs), in-school (ISS), and out-of-school suspensions (OSS) received by participating students will be gleaned from school records and recorded at the student-level for two academic years (6th grade and 7th grade).
Measured: baseline, 12 months
Change from Baseline in Number of Days Absent from School (Student-Level)
The number of days that participating students were absent from school will be gleaned from school records and recorded at the student-level for two academic years (6th grade and 7th grade).
Measured: Time Frame: baseline, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start13 Aug 2025
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for School AttendanceStudies 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
- Sequential
- Model description
- Sequential Multiple Assignment Randomization Trial (SMART)
- Masking
- None (open label)
- Enrolment
- 1,440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oregon
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Beth Stormshak, PhD, Principal investigator, University of OregonRhonda Nese, PhD, Principal investigator, University of Oregon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07264621
- Sponsor's protocol ID
- STUDY00001745
- Other IDs
- 1P50MH139449
- Status last verified
- Nov 2025
- First submitted
- 24 Nov 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified, final research data generated in the research activities, along with metadata, descriptors, and protocols, will be shared with the broader scientific community. Material to be shared include detailed protocols and recommendations for schools to increase the health and wellbeing of middle schoolers. Researchers outside of the ACCESS Center will have access to a standard de-identified, individual-level dataset held to the same standard as that established by the HIPAA Privacy Rule. General documentation will be available without cost in the form of PDF files. Potentially identifying fields as defined in the HIPAA Privacy Rule will not be released to outside researchers.
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Multi-tiered School-based Prevention to Promote Youth Mental Health and Create Equitable and Sustainable Systems of Care
- ClinicalTrials.gov ID
- NCT07264621
- Acronym / sponsor ID
- STUDY00001745
- Conditions
- School Attendance, School Climate, School Engagement, School Exclusion, Externalizing Behavior, Disparities
- Keywords
- school-based intervention, family intervention, middle school, SMART trial
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,440 participants (estimated)
- Lead sponsor
- University of OregonUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 13 Aug 2025 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Mar 2030 (estimated)
- First posted
- 4 Dec 2025 (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 learn if two behavioral interventions work to reduce office disciplinary referrals, improve attendance, and reduce depression and anxiety in 7th grade students. This project combines two evidence-based programs-the Inclusive Skill-building Learning Approach (ISLA) for school-wide discipline reform and the Family Check-Up Online (FCU-O) for family-centered support-in an adaptive design to examine the unique and additive effects of these interventions on these child behavior outcomes.
The main questions it will answer are:
- What is the relative efficacy of ISLA vs. School-as-Usual?
- What is the optimal sequencing of these interventions?
- Which overall sequence of intervention strategies was most effective?
Researchers will compare 6 combinations of these interventions to see which combination and sequencing provides the best student outcomes.
School personnel participating in the project will be trained to implement the two interventions at their school. They will answer surveys in the fall, winter, and spring of their year of participation. Parent and Youth participants will complete surveys at baseline and then again 6 months and 12 months later.
Detailed description
In the past decade, youth mental health and behavior concerns have been some of the most significant challenges in schools, exacerbated by the COVID-19 pandemic. A high percentage of adolescents experience mental health distress, but only a fraction of them recieve adequate services, especially in underserved communities. School-based services face barriers such as limited funding, staffing shortages, and a lack of evidence-based programming. Mental health issues are driven by a combination of individual and systemic risk factors, including inequitable school policies, caregiver stress, and family history of mental health disorders. Youth from minoritized backgrounds face higher stressors, further impacting their mental health. Due to the complexity and depth of these issues, an approach that intervenes on a school- and family-level could show significant reduction in mental health and behavioral concerns which would otherwise precipitate into a lifetime of cascading negative outcomes.
Effective strategies that can aid in this youth mental health epidemic include family-centered treatments and school-wide programs to reduce exclusionary discipline practices, which disproportionately affect marginalized students and contribute to the school-to-prison pipeline. Family engagement in mental health interventions has shown positive, long-term effects, but participation rates remain low, with most school programs focusing on individual students rather than families.
This project aims to highlight the importance of embedding mental health services in schools by way of providing schools with equitable skill-building supports to improve student social and behavioral problem-solving, as well as providing families with a brief, strengths-based, digital health intervention for families to reduce mental health and behavioral concerns by improving emotional regulation and family relationships. Digital health interventions, like web-based programs, offer a promising solution to reach underserved families and students. This project combines two evidence-based programs-the Inclusive Skill-building Learning Approach (ISLA) for school-wide discipline reform and the Family Check-Up Online (FCU-O) for family-centered support-in an adaptive design. Integrating a family-centered intervention that promotes positive and nurturing familial relationships with a systemic intervention that addresses inequitable discipline practices in schools provides a promising and innovative approach for reducing the youth mental health crisis across multiple systems, including home, school, and communities. This approach aims to reduce mental health issues by addressing both school and family dynamics. The project evaluates the effectiveness and sustainability of these interventions using a multi-level model and randomized trials.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Sequential Multiple Assignment Randomization Trial (SMART)
| Arm | Type | Receives |
|---|---|---|
| School-As-Usual (SAU) Only | No intervention | –Students were selected to participate in the study based on meeting attendance and behavioral criteria in 6th grade for Tier 2 or Tier 3 school supports. Students in this arm attended 7th grade at a school in the School-As-Usual condition and therefore did not receive the Tier 1 intervention, ISLA. In addition, in January of 7th grade their school behavior and attendance no longer met criteria for assignment to the Tier 2 intervention, the Family Check-up Online. Thus, students in this arm received neither the ISLA nor FCU-O interventions. |
| SAU + FCU Online Only | Experimental | Behavioral: Family Check-Up Online (FCU-O)Students were selected to participate in the study based on meeting attendance and behavioral criteria in 6th grade for Tier 2 or Tier 3 school supports. Students in this arm attended 7th grade at a school in the School-As-Usual condition and therefore did not receive the Tier 1 intervention, ISLA. In January of 7th grade their school behavior and attendance continued to meet criteria for assignment to Tier 2 intervention, and thus they received the Family Check-Up Online. In this arm, students' parents were assigned to receive the Family Check-Up Online digital intervention only (without supportive telehealth coaching). |
| SAU + FCU Online with Telehealth Coaching | Experimental | Behavioral: FCU-Online with telehealth coachingStudents were selected to participate in the study based on meeting attendance and behavioral criteria in 6th grade for Tier 2 or Tier 3 school supports. Students in this arm attended 7th grade at a school in the SAU condition, and therefore did not receive the Tier 1 intervention, ISLA. In January of 7th grade their school behavior and attendance continued to meet criteria for Tier 2 intervention, and thus they received the Family Check-Up Online. In this arm, students' parents were assigned to receive the Family Check-Up Online digital intervention and telehealth coaching to support uptake of FCU content. |
| ISLA intervention + FCU Online Only | Experimental | Behavioral: Inclusive Skill-building Learning Approach (ISLA), Behavioral: Family Check-Up Online (FCU-O)Students were selected to participate in the study based on meeting attendance and behavioral criteria in 6th grade for Tier 2 or Tier 3 school supports. Students in this arm attended 7th grade at a school which implemented the school-wide Tier 1 intervention, ISLA. In January of 7th grade their school behavior and attendance continued to meet criteria for Tier 2 intervention, and thus they received the Family Check-Up Online. In this arm, students' parents were assigned to receive the Family Check-Up Online digital intervention only (without supportive telehealth coaching). |
| ISLA intervention+ FCU Online with Telehealth Coaching | Experimental | Behavioral: Inclusive Skill-building Learning Approach (ISLA), Behavioral: FCU-Online with telehealth coachingStudents were selected to participate in the study based on meeting attendance and behavioral criteria in 6th grade for Tier 2 or Tier 3 school supports. Students in this arm attended a school which implemented the school-wide Tier 1 intervention, ISLA. In January of 7th grade their school behavior and attendance continued to meet criteria for Tier 2 intervention, and thus they received the Family Check-Up Online. In this arm, students' parents were assigned to receive the Family Check-Up Online digital intervention with telehealth coaching to support uptake of the FCU content. |
| ISLA Intervention Only | Experimental | Behavioral: Inclusive Skill-building Learning Approach (ISLA)Students were selected to participate in the study based on meeting attendance and behavioral criteria in 6th grade for Tier 2 or Tier 3 school supports. Students in this arm attended a school which implemented the school-wide Tier 1 intervention, ISLA. In January of 7th grade their attendance and behavior no longer met criteria for Tier 2 intervention. Thus, their parents were not offered the FCU Online digital intervention. |
Who may qualify
- Ages
- 11 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| Inclusive Skill-building Learning Approach (ISLA)ISLA is a school-wide, multi-component, instructional and restorative alternative to exclusionary discipline that involves universal prevention grounded in positive, preventative classroom strategies for all students, and layers on additional supports for students in need.Derived from the original School-Wide Positive Behavioral Interventions model (SWPBIS) with roots in social learning theory, ISLA emphasizes that behavior is learned through modeling and teaching, and that environmental factors and the quality of teaching practices influence when and how a behavior is likely to occur. The ISLA model emphasizes ongoing training and coaching of classroom-level prevention strategies and practices that teachers use to promote building strong relationships, preventing school disconnectedness, and improving instructional and restorative alternatives to exclusion. | Behavioural | ISLA Intervention Only, ISLA intervention + FCU Online Only, ISLA intervention+ FCU Online with Telehealth Coaching |
| Family Check-Up Online (FCU-O)The Family Check-Up Online is a digital intervention that includes an assessment, computer-generated feedback, and intervention modules that focus on improving family relationships and parenting skills in order to reduce child mental health problems and to improve child self-regulation. These modules include Healthy Behaviors for Stressful Times, Positive Parenting, Rules and Consequences, Supporting School Success, and Communication. | Behavioural | ISLA intervention + FCU Online Only, SAU + FCU Online Only |
| FCU-Online with telehealth coachingThis intervention is the Family Check-Up Online plus telehealth support from a parenting coach. The Family Check-Up Online is a digital intervention that includes an assessment, computer-generated feedback, and intervention modules that focus on improving family relationships and parenting skills in order to reduce child mental health problems and to improve child self-regulation. These modules include Healthy Behaviors for Stressful Times, Positive Parenting, Rules and Consequences, Supporting School Success, and Communication. A coach based at the child's school meets with caregivers via telehealth modality to provide motivation and to help caregivers tailor the content of the modules to their specific child and family's needs. | Behavioural | ISLA intervention+ FCU Online with Telehealth Coaching, SAU + FCU Online with Telehealth Coaching |
Primary outcome
Change from Baseline in Child Depression (Parent Report)
Time frame: baseline, 6 months, 12 months
Parents report on their child's depression using the eight item PHQ-8. Parents are asked to indicate how often their child has experienced symptoms over the last two weeks using a 4-pt Likert scale: 0 =not at all, 1=several days, 2=more than half the days, 3= nearly every day. Scores for individual items are summed together. Higher scores indicate greater child depression.
Change from Baseline in Child Depression (Student Report)
Time frame: baseline, 6 months, 12 months
Students report on their symptoms of depression using the eight item PHQ-8. Students are asked to indicate how often they have experienced symptoms over the last two weeks using a 4-pt Likert scale: 0 =not at all, 1=several days, 2=more than half the days, 3= nearly every day. Scores for individual items are summed together. Higher scores indicate greater child depression.
Change from Baseline in Child Anxiety (Parent Report)
Time frame: baseline, 6 months, 12 months
Parents report on their child's anxiety using the 7 item GAD-7. Parents are asked to indicate how often their child has experienced symptoms over the past 2 weeks using a 4-pt Likert scale: 0= not at all, 1=several days, 2=more than half the days, and 3= nearly every day. Ratings of the 7 items are summed together. Higher scores indicate greater child anxiety.
Change from Baseline in Child Anxiety (Student Report)
Time frame: baseline, 6 months, 12 months
Students report on their symptoms of anxiety using the 7 item GAD-7. Students are asked to indicate how often they have experienced symptoms over the past 2 weeks using a 4-pt Likert scale: 0= not at all, 1=several days, 2=more than half the days, and 3= nearly every day. Ratings of the 7 items are summed together. Higher scores indicate greater child anxiety.
Change from Baseline in Student Problem Behaviors (Parent Report)
Time frame: baseline, 6 months, 12 months
The Strengths and Difficulties Questionnaire (SDQ; Goodman 1997) is a 25-item behavioral screening questionnaire about psychosocial problems for youth, and includes competencies or strengths in addition to assessing problems. The SDQ is equally divided across five scales measuring emotional symptoms, conduct problems, hyperactivity-inattention, peer problems, and prosocial behavior. Parents are provided statements and asked to indicate how true each statement has been for their child over the past 6 months using a 3-pt Likert scale: 0=Not True, 1=Somewhat True, and 2=Certainly True. Ratings are summed, and higher scores indicate more problem behavior.
Change from Baseline in Student Problem Behaviors (Student Report)
Time frame: baseline, 6 months, 12 months
The Strengths and Difficulties Questionnaire (SDQ; Goodman 1997) is a 25-item behavioral screening questionnaire about psychosocial problems for youth, and includes competencies or strengths in addition to assessing problems. The SDQ is equally divided across five scales measuring emotional symptoms, conduct problems, hyperactivity-inattention, peer problems, and prosocial behavior. Students are provided statements and asked to indicate how true each statement has been for them over the past 6 months using a 3-pt Likert scale: 0=Not True, 1=Somewhat True, and 2=Certainly True. Ratings are summed, and higher scores indicate more problem behavior.
Change from Baseline in School Climate (Student Report)
Time frame: baseline, 6 months, 12 months
The School Climate Survey: Secondary (SCS-S) is a 36-item school climate rating scale (Center on PBIS, 2022) intended to obtain middle and high school student perception ratings of school climate. It has 8 subscales: school connectedness, peer social support, adult social support, cultural acceptance, social/ civic learning, physical environment, school safety, and order and discipline. Respondents use a 4-point Likert scale: 1=Strongly Disagree, 2 = Somewhat Disagree, 3 = Somewhat Agree, and 4 = Strongly Agree. To compute the overall school climate score, item responses are summed and then divided by the total number of items. Higher overall scores reflect a more positive sense of the school environment.
Change from Baseline in School Climate (Teacher Report)
Time frame: Fall, Winter, and Spring of one academic year (e.g., baseline, 6 months, 10 months)
The School Climate Survey: School Personnel (Center on PBIS, 2022) includes 29 items and 5 subscales, including staff connectedness, structure for learning, school safety, physical environment, peer and adult relations, and parent involvement. School personnel rate items with a four-point Likert scale: 1=Strongly Disagree, 2=Somewhat Disagree, 3=Somewhat Agree, and 4=Strongly Agree. To compute the overall school climate score, item responses are summed and then divided by the total number of items. Higher overall scores reflect a more positive sense of the school environment.
Change from Baseline in Number of ODRs, In-School Suspensions, and Out-of-School Suspensions (School-Level)
Time frame: Fall, winter, and spring of two academic years (baseline, 6 months, 9 months, 12 months, 18 months, 21 months)
The number of office disciplinary referrals (ODRs), in-school (ISS), and out-of-school suspensions (OSS) will be gleaned from school records and aggregated at the school-level.
Change from Baseline in Number of ODRs, In-School Suspensions, and Out-of-School Suspensions (Student-Level)
Time frame: baseline, 12 months
The number of office disciplinary referrals (ODRs), in-school (ISS), and out-of-school suspensions (OSS) received by participating students will be gleaned from school records and recorded at the student-level for two academic years (6th grade and 7th grade).
Change from Baseline in Number of Days Absent from School (Student-Level)
Time frame: Time Frame: baseline, 12 months
The number of days that participating students were absent from school will be gleaned from school records and recorded at the student-level for two academic years (6th grade and 7th grade).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Individual participant dataSharing planned: Yes. De-identified, final research data generated in the research activities, along with metadata, descriptors, and protocols, will be shared with the broader scientific community. Material to be shared include detailed protocols and recommendations for schools to increase the health and wellbeing of middle schoolers. Researchers outside of the ACCESS Center will have access to a standard de-identified, individual-level dataset held to the same standard as that established by the HIPAA Privacy Rule. General documentation will be available without cost in the form of PDF files. Potentially identifying fields as defined in the HIPAA Privacy Rule will not be released to outside researchers.
Related trials for School Attendance
Active, not recruiting
Correcting Myopia Among Secondary School Children to Increase Academic High School Attendance Rates in Rural Communities
Refractive Errors
Recruiting
Optimization and Testing Effectiveness of a Collaborative Intervention for School Attendance Problems in Norwegian Municipalities
School Attendance Problems
Recruiting
Taabo Tutoring Study
Secondary School Entry and Completion, Education Advancement
Not yet recruitingPhase 3
OPTIMAL LEAP: Optimizing Dihydroartemisinin-Piperaquine IPTsc Intervals to Advance Learning, Executive Function, Attendance, and Antimalarial Resistance Surveillance in Kenyan Schoolchildren
Malaria, Asymptomatic Malaria
Recruiting
Health Equity and Rural Education (HERE!) Clinical Trial
Behavioral Symptoms, Community Health Workers
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.
Beth Stormshak, PhD principal investigator
University of Oregon
Rhonda Nese, PhD principal investigator
University of Oregon
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inclusive Skill-building Learning Approach (ISLA), Family Check-Up Online (FCU-O) and FCU-Online with telehealth coaching in people with School Attendance and School Climate, run by University of Oregon at 13 sites 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?
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: enrolling by invitation, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites 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?
This study is still under way. Results are not available in the source record yet.
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 Child Depression (Parent Report) (time frame: baseline, 6 months, 12 months). The study lists 11 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 4 Dec 2025.