What side effects are associated with this type of intervention?

Common treatments for learning difficulties, particularly those involving educational and employment supports, include individualized education programs (IEPs), cognitive-behavioral therapy (CBT), and vocational training. These interventions generally have minimal physical side effects but can sometimes lead to emotional or psychological stress due to the demands of the programs. For instance, students may experience frustration or anxiety when facing challenging tasks or adjusting to new routines. Additionally, the effectiveness of these interventions can vary, and lack of progress may lead to decreased motivation or self-esteem.

What prior FDA approvals exist?

The FDA has approved several medications for conditions that can impact learning difficulties, such as ADHD, which include stimulants like methylphenidate and amphetamines, as well as non-stimulants like atomoxetine. These medications help improve focus and behavior, which can indirectly support educational and employment outcomes. However, there are no specific FDA-approved drugs solely for learning difficulties. The trial on Manualized Educational and Employment Supports focuses on non-pharmacological interventions, combining educational and employment supports to enhance economic self-sufficiency, which is a different approach from pharmacotherapy.

What other types of research exist?

Promising novel alternatives to Manualized Educational and Employment Supports for young adults with learning difficulties include: 1) Digital and AI-driven personalized learning platforms that adapt to individual learning styles and paces, 2) Virtual reality (VR) and augmented reality (AR) tools for immersive skill training and job simulations, 3) Neurofeedback and cognitive training programs to enhance executive functioning and cognitive skills, 4) Integrated support systems combining teletherapy, online coaching, and peer support networks, and 5) Community-based programs that offer real-world job training and placement services in collaboration with local businesses.

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Skills Training for Young Adults with Mental Disabilities (HYPE Trial)

N/A

Waitlist Available

Led By Michelle Mullen, MS

Research Sponsored by University of Massachusetts, Worcester

Eligibility Criteria Checklist

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

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

Summary

This trial tests the HYPE Model, a program that helps college students with mental health issues by providing both educational and job support. It targets young adults who need help with both school and work. The program combines tutoring and job placement services to help students succeed academically and start their careers.

Who is the study for?

This trial is for young adults aged 18-30 with mental health conditions who are fluent in English, planning to enroll in at least four semesters of college, and have experienced academic disruptions. They must be enrolled in a minimum of six credits at an accredited college and have a diagnosed mental health condition or ADA protections.

What is being tested?

The HYPE trial tests a new program combining educational and employment support for students with mental health issues on campus. It includes Focused Skill Training, weekly meetings with specialists, and enhanced usual services compared to standard support.

What are the potential side effects?

Since this is not a medical intervention, there aren't typical side effects like you'd see with medications. However, participants may experience stress or anxiety from the increased focus on employment skills and managing their education.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Number of students making satisfactory academic progress

Number of students with disruptions toward completion of college degree.

Secondary study objectives

Academic Self-Efficacy

Change in frequency of educational barriers

Change in levels of perceived Stress

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Experimental Group: HYPE ServicesExperimental Treatment2 Interventions

The experimental arm will receive the HYPE intervention for 12 months.

Group II: Control Group: Enhanced Academic Services as UsualActive Control1 Intervention

The control arm will receive a special personalized packet of resources available on campus and off-campus within a 10-mile radius, as "enhanced academic services as usual."

Do I qualify?Apply below to find out

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 learning difficulties often involve individualized educational interventions that focus on enhancing specific skills such as phonemic awareness, reading fluency, and comprehension. These interventions typically include systematic instruction, repeated practice, and the use of supportive tools like visual aids and structured routines. The mechanisms of action involve breaking down complex tasks into manageable steps, providing consistent feedback, and fostering a supportive learning environment. This approach is crucial for patients with learning difficulties as it addresses their unique needs, promotes skill acquisition, and enhances their ability to function independently. Similar to the Manualized Educational and Employment Supports trial, these treatments aim to improve not only academic performance but also overall self-sufficiency and quality of life by integrating educational and practical skills training.

Self-management of vocational skills for people with significant intellectual disabilities: A systematic review.Recommended practices to organize and deliver school-based services for children with disabilities: A scoping review.Personal assistance for children and adolescents (0-18) with both physical and intellectual impairments.

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Who is running the clinical trial?

University of Massachusetts, WorcesterLead Sponsor

356 Previous Clinical Trials

992,112 Total Patients Enrolled

Colorado State UniversityOTHER

131 Previous Clinical Trials

38,115 Total Patients Enrolled

National Institute on Disability, Independent Living, and Rehabilitation ResearchFED

77 Previous Clinical Trials

9,548 Total Patients Enrolled

Media Library

Learning Difficulties Clinical Trial 2023: Focused Skill and Strategy Training (FSST) Highlights & Side Effects. Trial Name: NCT04254562 — N/A

~17 spots leftby Sep 2025

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