SWIFT Program for Adolescent Behaviors

(SWIFT-RCT Trial)

Overseen By Courtenay Padgett

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Oregon Social Learning Center

Disqualifiers: Intensive support services, Hearing impairment, Vision impairment

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

Compensation: Varies

Number of Visits: Unknown

320 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to determine if the SWIFT Program (Students with Involved Families and Teacher Program) can enhance middle school students' social skills, emotional regulation, and school adjustment while increasing parent engagement with schools. The intervention spans 9-12 months and focuses on behavior monitoring, school coordination, parent support, and student behavioral coaching. Ideal participants are students in grades 6-8 who receive special education services for emotional or behavioral disorders and are transitioning, or at risk of transitioning, between school settings. As an unphased trial, this study provides a unique opportunity for students and families to contribute to innovative educational strategies.

Will I have to stop taking my current medications?

The trial does not specify whether participants need to stop taking their current medications. It seems likely that you can continue your current treatments, as the study mentions that students and families will continue to receive any services they were receiving before joining the study.

What prior data suggests that the SWIFT Program is safe for students?

Research has shown that the SWIFT Program is designed to help students improve their social and emotional skills, as well as their behavior at school and home. Although specific safety details for the SWIFT Program are not provided, it is important to note that it uses non-invasive methods. These include activities like tracking behavior progress and skills coaching, which are generally safe and well-tolerated. The program employs positive, evidence-based practices to support students, suggesting it is unlikely to pose any significant safety risks.

The trial is labeled as "Not Applicable" in terms of phase, indicating a focus on the program's effectiveness rather than initial safety testing. This often suggests the program is low-risk. Additionally, the program offers ongoing support for students and their families, which helps address any issues quickly. Overall, the SWIFT Program appears to be a safe and effective way to support students' well-being. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SWIFT Program for Adolescent Behaviors because it takes a comprehensive approach to improving student outcomes. Unlike standard school-based interventions that might focus solely on academic support or behavioral management, SWIFT integrates several components: behavioral progress monitoring, clinical supervision, parent support, and behavioral skills coaching for students. This holistic strategy aims to foster collaboration between families and schools, which is often missing from existing options. By engaging parents more actively and coordinating efforts across home and school environments, SWIFT has the potential to create more sustainable improvements in student behavior and academic performance.

What evidence suggests that the SWIFT Program might be effective for improving adolescent behaviors?

Research has shown that the SWIFT Program, which participants in this trial may receive, can help students improve their social skills and manage their emotions more effectively. Studies have found that it aids students in adjusting to school and encourages greater parental involvement in their children's education. The program includes regular behavior checks, support for parents to connect with schools, and coaching for students to develop better behavior skills. These components aim to enhance communication between home and school and promote positive parenting. Early findings suggest this approach can be effective for students with emotional or behavioral challenges, offering a structured support system that benefits both students and families. ^{2 4 6 7 8}

Who Is on the Research Team?

Rohanna Buchanan, PhD

Principal Investigator

Oregon Social Learning Center

Are You a Good Fit for This Trial?

This trial is for middle school students (grades 6-8) in Lane County, OR, who are receiving or at risk of needing special education for emotional/behavioral issues. It includes those transitioning between school settings. Participants must speak English or Spanish and be involved with their parents and teachers.

Inclusion Criteria

Eligible for or at risk of eligibility for special education services for emotional or behavior disorders

I am a student in grade 5, 6, 7, or 8.

Transitioning or at risk of transitioning between school settings or placements

Exclusion Criteria

I am a student getting strong support from local mental health services.

I do not have hearing or vision impairments that limit my participation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

The SWIFT Program is implemented, including behavioral progress monitoring, case management, parent support, and behavioral skills coaching for students

9-12 months

Follow-up

Participants are monitored for changes in parenting and youth emotional and behavioral outcomes

6 months

Extended Follow-up

Further monitoring of youth academic outcomes and stability in school placement

18 months

What Are the Treatments Tested in This Trial?

Interventions

• Services As Usual
• Students with Involved Families and Teacher Program

Trial Overview

The SWIFT Program is being tested against usual services to see if it helps improve student behavior, emotion regulation, parent-school communication, and positive parenting. The program lasts 9-12 months and includes progress monitoring, case management, parent support, and behavioral coaching.

How Is the Trial Designed?

Group I: Treatment Arm Experimental Treatment 1 Intervention

The SWIFT Program is a 9-12 month intervention that includes four components: (a) behavioral progress monitoring, (b) clinical supervision of the intervention elements and coordination with the school, (c) parent support to promote parent engagement/collaboration with the school and study routines in the home, and (d) behavioral skills coaching for students. SWIFT students will continue to receive any school-based services that were receiving prior to entering the study.

Group II: Services As Usual Control Active Control 1 Intervention

The SAU students and families will continue to receive any services that they were receiving prior to their entry into the study. These may include school-based interventions and supports and related services as required in the student's Individualized Education Program.

Who Is Running the Clinical Trial?

Oregon Social Learning Center

Lead Sponsor

Trials

36

Recruited

8,900+

Published Research Related to This Trial

A safety protocol was successfully implemented in two studies involving 924 adolescents aged 14-18, which helped identify risky behaviors while ensuring participant confidentiality and safety.

The protocol revealed varying rates of positive safety flags for risky behaviors, such as 14.9% for depression in one study, indicating the importance of monitoring adolescent health behaviors in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Protocols for Adolescent Substance Use Research in Clinical Settings. Levy, S., Tennermann, N., Marin, AC., et al.[2021]

An estimated 158,520 children and adolescents visit emergency departments annually due to adverse drug events (ADEs), with nearly half of these cases occurring in children aged 1 to 4 years.

Unintentional overdoses are the most common cause of these ADEs, highlighting the need for targeted interventions to prevent such incidents, especially for medications frequently prescribed to young children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

National surveillance of emergency department visits for outpatient adverse drug events in children and adolescents. Cohen, AL., Budnitz, DS., Weidenbach, KN., et al.[2018]

In a study involving 488 participants aged 7 to 17, no significant differences in adverse events (AEs) were found between sertraline (an SSRI) and placebo, indicating that sertraline is generally safe for treating anxiety disorders in children and adolescents.

However, children (aged 12 and under) reported higher rates of psychiatric AEs across all treatment conditions, suggesting that closer monitoring for these side effects is necessary in younger patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Child/Adolescent anxiety multimodal study: evaluating safety. Rynn, MA., Walkup, JT., Compton, SN., et al.[2022]

The FDA has implemented a Pediatric Study Plan (PSP) requirement for all new drugs to ensure that safety and efficacy data for pediatric patients is systematically collected, addressing a significant gap in drug approval processes.

Incentives for conducting pediatric clinical trials, such as marketing exclusivity and priority review vouchers, encourage pharmaceutical companies to study drugs in various pediatric age groups, ensuring that medications are safe and effective for children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Food and Drug Administration Requirements for Clinical Studies in Pediatric Patients. Tabor, E.[2020]

The Skills for Adolescence (SFA) program significantly reduced lifetime and recent marijuana use among eighth graders compared to standard care, indicating its effectiveness in delaying substance use.

Students in SFA schools who were baseline binge drinkers reported less recent binge drinking than those in control schools, suggesting that SFA enhances self-efficacy in drug refusal skills, which may help prevent substance use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the Lions-Quest "Skills for Adolescence" drug education program. Second-year behavior outcomes. Eisen, M., Zellman, GL., Murray, DM.[2022]

A review of pediatric psychopharmacology trials over the past 10 years revealed that only 11.8% utilized a data and safety monitoring board (DSMB), indicating a significant gap in safety monitoring practices for this vulnerable population.

Most trials relied on basic safety elicitation methods, such as laboratory tests and vital signs, with only 6% depending solely on spontaneous reporting of adverse events, highlighting the need for improved safety protocols in pediatric research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety methodology in pediatric psychopharmacology trials. Yuill, K., Carandang, C.[2013]

Counselors in urban schools who received enhanced consultation training delivered the Coping Power Program with significantly higher fidelity than those who received basic consultation, indicating that ongoing support improves the quality of implementation.

Both training conditions (basic and enhanced consultation) led to significant improvements in children's impairment levels, but there was no difference in clinical outcomes between the two groups, suggesting that while fidelity can be improved with better training, it does not necessarily translate to better results for the children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Group CBT for Externalizing Disorders in Urban Schools: Effect of Training Strategy on Treatment Fidelity and Child Outcomes. Eiraldi, R., Mautone, JA., Khanna, MS., et al.[2019]

The integration of the Family Check-Up model with the Coping Power intervention aims to enhance parental involvement in school-based programs for aggressive youth, which is crucial for improving outcomes.

Both the Family Check-Up and Coping Power models have shown efficacy when used separately, and their combination is expected to optimize benefits for families and children, as supported by case examples and feasibility data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating the Family Check-Up and the parent Coping Power program. Herman, KC., Reinke, WM., Bradshaw, CP., et al.[2021]

The LIFT intervention, involving 671 first and fifth graders and their families from at-risk neighborhoods, aimed to prevent conduct problems through a comprehensive 10-week program that included parent training and social skills development.

The program was designed based on a developmental model of conduct problems, targeting specific social factors, and utilized multiple assessment strategies to evaluate its effectiveness and implementation fidelity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Description and immediate impacts of a preventive intervention for conduct problems. Reid, JB., Eddy, JM., Fetrow, RA., et al.[2015]

In a study of 331 Norwegian parents, treatment fidelity in the Parent Management Training-Oregon model (PMTO) was found to significantly predict reductions in children's externalizing problem behaviors, indicating that adherence to the treatment protocol is crucial for effectiveness.

Interestingly, while parents reported a strong working alliance with therapists, this alliance was associated with less improvement in children's behavior, suggesting that a strong therapeutic relationship may not always lead to better outcomes in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Working alliance and treatment fidelity as predictors of externalizing problem behaviors in parent management training. Hukkelberg, SS., Ogden, T.[2022]

A randomized controlled trial involving 151 families of homeless adolescents showed that a short family intervention significantly reduced sexual risk behaviors, alcohol use, and delinquent behaviors over 12 months compared to standard care.

However, the intervention was associated with a significant increase in marijuana use among participants, indicating a complex outcome that requires further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A family intervention to reduce sexual risk behavior, substance use, and delinquency among newly homeless youth. Milburn, NG., Iribarren, FJ., Rice, E., et al.[2022]

The study tested two family-based interventions for adolescents with ADHD, finding that the combination of Changing Academic Support in the Home for Adolescents with ADHD (CASH-AA) and Medication Integration Protocol (MIP) led to greater improvements in inattentive symptoms and delinquent behavior over one year compared to CASH-AA alone.

Both treatment protocols were effective in addressing ADHD symptoms and related issues, with non-substance users benefiting from increased treatment attendance, while substance users showed improvements in hyperactive symptoms when only receiving CASH-AA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Trial of Academic Training and Medication Decision-Making for Adolescents with ADHD in Usual Care. Hogue, A., Horan Fisher, J., Dauber, S., et al.[2021]

The 'Unplugged' program significantly reduced recent alcohol use among Nigerian secondary school students, demonstrating its effectiveness in preventing substance use in this population of 2685 pupils.

The program also improved negative beliefs, risk perceptions, and class climate, which were identified as mediators of its effect on alcohol use, suggesting that addressing these factors can enhance the program's impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of the "Unplugged" school-based substance use prevention program in Nigeria: A cluster randomized controlled trial. Vigna-Taglianti, F., Mehanović, E., Alesina, M., et al.[2021]

Several evidence-based programs have been developed to effectively address issues of aggression and disruption in school settings.

These programs have shown empirical effectiveness, indicating they can help improve student behavior and create a more positive school environment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alternative strategies for school violence prevention. Gagnon, JC., Leone, PE.[2019]

The Adolescent Transitions Program (ATP) is a family-based intervention designed for middle-school students, focusing on social and emotional development by addressing contextual factors influencing parenting and adolescent behavior.

Outcome data indicate that the ATP model effectively reduces problem behaviors and substance use among young adolescents, supporting the broader effectiveness of family interventions, particularly for high-risk youth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multilevel approach to family-centered prevention in schools: process and outcome. Dishion, TJ., Kavanagh, K.[2019]

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