Behavioral Interventions for Depression in Students

Enrolling by invitation at 12 trial locations

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Oregon

Disqualifiers: Non-English/Spanish literacy, Other study participation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 24

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two programs to determine their effectiveness in helping 7th-grade students reduce school discipline issues, improve attendance, and lessen feelings of depression and anxiety. The trial compares a school discipline program, the Inclusive Skill-building Learning Approach (ISLA), and a family support program, Family Check-Up Online (FCU-O), in different combinations. Students eligible for the trial should have had frequent discipline referrals or poor attendance in 6th grade. Researchers aim to discover which combination of these programs benefits students the most. As an unphased trial, this study provides a unique opportunity for students to benefit from innovative programs designed to enhance their school experience.

What prior data suggests that these behavioral interventions are safe for students?

Studies have shown that the Inclusive Skill-building Learning Approach (ISLA) safely and effectively improves school discipline without harsh punishments. This program teaches students better behavior, fostering a more positive school environment. No major safety concerns have been reported with ISLA, indicating it is well-tolerated by students.

Research indicates that the Family Check-Up Online (FCU-O) program is also safe. It supports parents and enhances family life by providing helpful parenting tips. Studies showed it reduced parent stress and improved parenting management. The program did not cause any serious issues for participating families.

When FCU-O includes telehealth coaching (support from a healthcare professional via video or phone calls), it remains safe. This additional support increased parental involvement and supported mental health. No safety problems were reported with the inclusion of telehealth coaching.

In summary, both ISLA and FCU-O, with or without telehealth coaching, appear safe and well-tolerated by students and families involved. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these behavioral interventions for depression in students because they offer innovative approaches tailored to the school environment. The Inclusive Skill-building Learning Approach (ISLA) is unique because it integrates school-wide support to improve student behavior and attendance, which are crucial factors in mental health. The Family Check-Up Online (FCU-O) extends support to families through digital platforms, providing flexibility and accessibility, and when combined with telehealth coaching, this approach can enhance parental engagement and the effectiveness of the intervention. Unlike traditional therapies that often require in-person sessions, these interventions leverage technology to reach students and families in a more dynamic and accessible way, potentially leading to quicker and more sustainable improvements in student well-being.

What evidence suggests that this trial's treatments could be effective for reducing depression and anxiety in students?

Research has shown that the Inclusive Skill-building Learning Approach (ISLA), one of the interventions in this trial, reduces school suspensions and improves student behavior. It emphasizes teaching skills over traditional discipline methods. Studies have found that ISLA leads to better attendance and fewer behavior problems.

The Family Check-Up Online (FCU-O) program, another intervention in this trial, enhances parenting skills and reduces parental stress. It helps parents set boundaries and boosts their confidence in managing family life. However, evidence is limited regarding its direct impact on children’s outcomes without additional support.

Adding telehealth coaching to FCU-O, included in some treatment arms of this trial, increases participation and effectiveness. This approach provides parents with more support, potentially improving their children's emotional health. Research has shown that telehealth coaching enhances the effectiveness of the FCU-O program. ^{1 2 3 6 7}

Who Is on the Research Team?

Beth Stormshak, PhD

Principal Investigator

University of Oregon

Rhonda Nese, PhD

Principal Investigator

University of Oregon

Are You a Good Fit for This Trial?

This trial is for 7th grade students experiencing issues like school phobia, bullying, emotional regulation problems, depression, and stress. It aims to help those with poor school attendance or facing disciplinary actions. Students with a stable internet connection for online interventions can participate.

Inclusion Criteria

School must be located in Oregon and serve a population with high levels of NIH-defined health disparity

School must have a history of collaboration with the National PBIS Technical Assistance Center or the Northwest PBIS network

School staff must be employed by a participating middle school

Exclusion Criteria

Caregiver is unable to read in either English or Spanish

Family is already participating in another study at the University of Oregon's Prevention Science Institute.

Either I or my child has chosen not to participate.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Implementation

School personnel are trained to implement ISLA and FCU-O interventions. Students and parents participate in the assigned intervention arm.

12 months

Surveys at baseline, 6 months, and 12 months

Follow-up

Participants are monitored for changes in depression, anxiety, and school behavior outcomes.

6 months

Surveys at 18 months

What Are the Treatments Tested in This Trial?

Interventions

• Inclusive Skill-building Learning Approach (ISLA)
• Family Check-Up Online (FCU-O)
• FCU-Online with telehealth coaching

Trial Overview The trial tests the Inclusive Skill-building Learning Approach (ISLA) against usual school discipline methods and examines if adding Family Check-Up Online (FCU-O), with or without telehealth coaching, improves student behavior outcomes.

How Is the Trial Designed?

Group I: SAU + FCU Online with Telehealth Coaching Experimental Treatment 1 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 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.

Group II: SAU + FCU Online Only Experimental Treatment 1 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 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).

Group III: ISLA intervention+ FCU Online with Telehealth Coaching Experimental Treatment 2 Interventions

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.

Group IV: ISLA intervention + FCU Online Only Experimental Treatment 2 Interventions

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).

Group V: ISLA Intervention Only Experimental Treatment 1 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 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.

Group VI: School-As-Usual (SAU) Only Active Control 1 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.

Who Is Running the Clinical Trial?

University of Oregon

Lead Sponsor

Trials

91

Recruited

46,700+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10018613/

Evaluating the Efficacy of the Family Check-Up Online to ... This study evaluated the effects of an enhanced version of the Family Check-Up Online (FCU-O), adapted to address parent and family functioning in response to ...

2. welcome.thefamilycheckup.com welcome.thefamilycheckup.com/resources

Resources This resource provides detailed information, reviews, data, links, and statistics about the Family Check-Up Model. Early Intervention Foundation Click above for ...

3. link.springer.com link.springer.com/article/10.1007/s11121-024-01725-3

Effects of a Virtual Randomized Trial on Parent Stress ... The FCU-O reduced caregiver stress and improved proactive parenting and limit setting but had no effects on youth outcomes.

4. cebc4cw.org cebc4cw.org/program/family-check-up/

CEBC » Program › Family Check Up The FCU model is a family-centered intervention that promotes positive family management and addresses child and adolescent adjustment problems.

5. sciencedirect.com sciencedirect.com/science/article/pii/S0885200624001364

Family Check-Up Online effects on parenting and ... The current study demonstrates the effectiveness of the FCU-O intervention for improving parent-reported parenting skills, parenting self-efficacy, and ...

6. welcome.thefamilycheckup.com welcome.thefamilycheckup.com/fcu-online

Online Program Our online program aims to provide support to parents by offering evidence and strength-based parenting strategies that can be tailored to individual family ...

7. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/99/NCT05117099/ICF_001.pdf

Long-term effects of the Family Check-Up on Depression ... The purpose of this research is to test the effectiveness of a web-based parenting curriculum (the Family Check-Up Online) to strengthen family functioning and ...