SWIFT Program for Adolescent Behaviors

(SWIFT-RCT Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Rohanna Buchanan, PhD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Oregon Social Learning Center

Disqualifiers: Intensive support services, Hearing impairment, Vision impairment

No Placebo Group

Trial Summary

What is the purpose of this trial?

PURPOSE: In the proposed project, the investigators seek to examine whether the SWIFT Program might be efficacious to improve students' prosocial skills and emotion and behavior regulation and improve home-school communication and the use of positive parenting practices for families. The investigators will also test whether the SWIFT program might be efficacious to improve students' longer-term school adjustment and parents' involvement in school. SETTING: Study activities will take place in ten school districts in Lane County, OR. The districts have approximately 10,000 middle school students (Grades 6-8), and approximately 60% of students are eligible for free and reduced price lunch. Some participating districts participated in the IES-funded Goal 2 study to develop the SWIFT Program. POPULATION: 320 students in Grades 6-8 who are receiving special education services for emotional or behavioral disorders, and transitioning or at risk of transitioning between school settings and placements will be recruited. Parents and content area teachers of all participating students will be recruited to complete assessment measures. It is expected that up to 15% of the children in the study will be of Latino ethnicity and approximately 60% will be European-American and 10-20% will be of other or multiple ethnicities. INTERVENTION: The SWIFT Program is a 9-12 month intervention that includes four components: (a) behavioral progress monitoring, (b) case management 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. SERVICES AS USUAL (SAU) CONTROL CONDITION: The SAU students and families will continue to receive any services that they were receiving prior to their entry into the study (as will the SWIFT students and families). These may include school-based interventions and supports and related services as required in the student's IEP.

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 data supports the effectiveness of the SWIFT Program treatment for adolescent behaviors?

The study on the Lions-Quest 'Skills for Adolescence' program, which is a comprehensive life skills training curriculum, showed that it was more effective than standard care in reducing substance use among middle school students. This suggests that similar life skills and family-based interventions, like the SWIFT Program, could be effective in addressing adolescent behaviors. ^{1 2 3 4 5}

Is the SWIFT Program for Adolescent Behaviors safe for humans?

The available research does not provide specific safety data for the SWIFT Program for Adolescent Behaviors, but general safety protocols in adolescent clinical trials emphasize the importance of monitoring and reporting adverse events to ensure participant safety. ^{6 7 8 9 10}

How is the SWIFT Program treatment different from other treatments for adolescent behaviors?

The SWIFT Program is unique because it involves a multilevel, family-centered approach within schools, focusing on the involvement of both families and teachers to address adolescent behaviors. This approach is based on an ecological framework that considers the social and emotional development of adolescents, making it distinct from other treatments that may not integrate family and school contexts as comprehensively. ^{11 12 13 14 15}

Research Team

Rohanna Buchanan, PhD

Principal Investigator

Oregon Social Learning Center

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Services As Usual (Behavioural Intervention)
• Students with Involved Families and Teacher Program (Behavioural Intervention)

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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 '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 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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Randomized Trial of Academic Training and Medication Decision-Making for Adolescents with ADHD in Usual Care. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Evaluating the Lions-Quest "Skills for Adolescence" drug education program. Second-year behavior outcomes. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Group CBT for Externalizing Disorders in Urban Schools: Effect of Training Strategy on Treatment Fidelity and Child Outcomes. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Working alliance and treatment fidelity as predictors of externalizing problem behaviors in parent management training. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

A family intervention to reduce sexual risk behavior, substance use, and delinquency among newly homeless youth. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Safety Protocols for Adolescent Substance Use Research in Clinical Settings. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

National surveillance of emergency department visits for outpatient adverse drug events in children and adolescents. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Safety methodology in pediatric psychopharmacology trials. [2013]

9. United States pubmed.ncbi.nlm.nih.gov

Child/Adolescent anxiety multimodal study: evaluating safety. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

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

11. Ireland pubmed.ncbi.nlm.nih.gov

Effects of the "Unplugged" school-based substance use prevention program in Nigeria: A cluster randomized controlled trial. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Alternative strategies for school violence prevention. [2019]

13. England pubmed.ncbi.nlm.nih.gov

Integrating the Family Check-Up and the parent Coping Power program. [2021]

14. England pubmed.ncbi.nlm.nih.gov

A multilevel approach to family-centered prevention in schools: process and outcome. [2019]

15. England pubmed.ncbi.nlm.nih.gov

Description and immediate impacts of a preventive intervention for conduct problems. [2015]