What side effects are associated with this type of intervention?

Common treatments for ADHD include both pharmacological and non-pharmacological approaches. Pharmacological treatments such as methylphenidate and atomoxetine are known to cause side effects like decreased appetite, nausea, vomiting, insomnia, and, in some cases, increased heart rate and blood pressure. Non-pharmacological treatments, such as the peer support and structured activities used in the summer STRIPES program, generally have fewer side effects but may include initial discomfort or anxiety as students adjust to new routines and social interactions. Overall, the side effects of non-pharmacological treatments are typically mild and manageable.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of ADHD, including stimulant medications like methylphenidate and amphetamines, which are often considered first-line treatments. Non-stimulant medications such as atomoxetine and alpha-2 adrenergic agonists like guanfacine and clonidine have also been approved. These medications help manage core symptoms of ADHD, which can facilitate the effectiveness of behavioral interventions such as peer support and structured activities, similar to those being studied in the summer STRIPES trial. While the FDA primarily focuses on pharmacological treatments, behavioral interventions are recognized as important complementary strategies.

What other types of research exist?

Promising alternatives to the summer STRIPES program for ADHD patients include: 1) Behavioral interventions and neurofeedback, as suggested by the ESCAschool study, which can be tailored to the severity of ADHD symptoms. 2) Yoga programs, which have shown improvements in sustained attention and discrimination function in children with ADHD. 3) Light therapy, particularly morning light exposure, which can help regulate sleep patterns and improve daytime functioning. 4) Pharmacotherapy, including updated medication algorithms, which remain a cornerstone of ADHD management.

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Peer Support for ADHD in Students (Summer STRIPES Trial)

Q: What is the mechanism of action of this treatment?

Common treatments for ADHD include stimulant medications like methylphenidate, which work by increasing dopamine and norepinephrine levels in the brain to enhance focus and attention. Non-pharmacological treatments, such as structured activities and peer support programs like the summer STRIPES, aim to improve organizational skills, reduce distractions, and provide social support. These approaches help manage ADHD symptoms by addressing both neurological and behavioral aspects, leading to better overall symptom management and improved daily functioning for patients.

N/A

Waitlist Available

Led By Margarret Sibley, Ph.D.

Research Sponsored by Seattle Children's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Meet Symptom and Impairment Criteria for DSM-5 ADHD

Be younger than 18 years old

Must not have

IQ < 70

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline to end of 9th grade, an average of 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a program called summer STRIPES for ninth graders with ADHD. The program includes an orientation and regular support to help students transition to high school. It aims to boost motivation and important skills through training and engaging activities. The goal is to improve grades, attendance, and behavior.

Who is the study for?

This trial is for ninth grade students who meet the criteria for ADHD according to DSM-5, which includes having symptoms and related challenges. They must be attending a participating school. Students with an IQ below 70 or those placed in special education classes cannot participate.

What is being tested?

The study is testing 'Summer STRIPES', a peer-delivered intervention, against enhanced usual school services (SSU plus) for high school freshmen with ADHD. The effectiveness will be measured by GPA, attendance, disciplinary incidents, and ADHD symptoms based on parent and teacher reports.

What are the potential side effects?

Since this trial involves educational interventions rather than medical treatments, there are no traditional side effects like you would expect from medication. However, participants may experience varying levels of stress or anxiety due to the nature of academic performance assessments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with ADHD according to DSM-5 criteria.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My IQ is below 70.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline to end of 9th grade, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline to end of 9th grade, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to end of 9th grade, an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Attention Deficit Hyperactivity Disorder Symptom Severity

Class Attendance

Grade Point Average

Other study objectives

Engagement and Fit Measures: Fidelity Checklists

Engagement and Fit Measures: Intervention Attendance

Engagement and Fit Measures: Intervention Credibility

+22 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Summer STRIPESExperimental Treatment1 Intervention

Up to two weeks of daily high school orientation (four hours per day) immediately prior to the start of ninth grade, staffed by peer interventionists (2:1 ratio + extra interventionist in case of absences) and a school staff member. Two sessions of summer parent training. During the school year, ninth grade students will continue to meet weekly with their peer interventionists in a group setting under the supervision of the school staff sponsor. School year follow-up component of summer STRIPES will occur for 16 weeks and will include weekly 30 minute meetings between peer and target students. Parent components during the school year will include optional monthly group problem solving sessions with the school staff sponsor and school mental health liaison and a weekly phone call (up to five minutes) from the school staff sponsor to discuss home contingency management.

Group II: Enhanced School Services as UsualActive Control1 Intervention

Students who are assigned to the SSU plus group will be referred to their identified school counselor for referral to services available in the school setting. The counselor will be provided with a report from the student's intake assessment that summarizes the student's symptoms and presenting problems. The student will also receive new school supplies at the beginning of ninth grade. In our past trials, SSU plus students typically received subject-specific tutoring or after-school homework help. We will systematically track services received by students in the SSU plus condition.

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for ADHD include stimulant medications like methylphenidate, which work by increasing dopamine and norepinephrine levels in the brain to enhance focus and attention. Non-pharmacological treatments, such as structured activities and peer support programs like the summer STRIPES, aim to improve organizational skills, reduce distractions, and provide social support. These approaches help manage ADHD symptoms by addressing both neurological and behavioral aspects, leading to better overall symptom management and improved daily functioning for patients.

Managing Sleep in Adults with ADHD: From Science to Pragmatic Approaches.Sleep in Individuals with ADHD: Prevalence, Impacts, Causes, and Treatments.Methylphenidate and hospitalized adolescents with conduct disorder: Dose effects on classroom behavior, academic performance, and impulsivity.