HOPS Intervention for ADHD

Overseen By Phylicia Fleming

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital of Philadelphia

Disqualifiers: Special education, Non-English speakers, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 16

Duration: 5 school months

240 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the Homework, Organization, and Planning Skills (HOPS) intervention to help students with ADHD improve organization and time management. The goal is to determine if the program, delivered by either school staff or a research team, effectively enhances students' skills in a real-world school setting. It compares students receiving the HOPS program to those on a waitlist. This trial suits students in grades 6 through 8 who are in general education classrooms and have been identified by teachers as needing help with organization and planning. As an unphased trial, this study offers students the chance to be among the first to benefit from a potentially impactful program designed to improve their academic skills.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that the HOPS Intervention is safe for students with ADHD?

Research shows that the HOPS (Homework, Organization, and Planning Skills) program has been tested in several studies and has helped middle school students with ADHD (Attention-Deficit/Hyperactivity Disorder). Importantly, these studies have not reported any safety concerns, noting no harmful side effects.

The HOPS program is an educational activity that helps students improve skills like organizing school materials and managing their time. By working with students on these skills, the program is generally well-tolerated, suggesting it is safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the HOPS Intervention for ADHD because it focuses on practical skill-building rather than medication. Unlike traditional ADHD treatments that often rely on medications to manage symptoms, HOPS is a hands-on program that helps students improve school materials organization, homework management, and time management through short, frequent sessions. This approach not only empowers students by teaching them valuable life skills but also involves both parents and teachers, creating a supportive network to enhance the student's success. This method could offer a non-pharmaceutical alternative that is particularly appealing to those seeking to avoid medication side effects.

What evidence suggests that the HOPS Intervention is effective for ADHD?

Research has shown that the Homework, Organization, and Planning Skills (HOPS) program, which participants in this trial may receive, can help students with ADHD improve their organizational skills. Studies have found that students in the HOPS program made significant progress in managing school materials, completing homework, and planning their time. For students with higher levels of hyperactivity and oppositional behavior, HOPS proved even more beneficial. Another study found that better homework recording and time management closely linked to improved parent ratings. Overall, the evidence supports HOPS as a promising way to address organization and planning challenges in students with ADHD. ^{1 2 4 6 7}

Who Is on the Research Team?

Thomas Power, PhD

Principal Investigator

Children's Hospital of Philadelphia

Jenelle Nissley-Tsiopinis, PhD

Principal Investigator

Children's Hospital of Philadelphia

Are You a Good Fit for This Trial?

This trial is for male or female students in grades 6-8, who are in general education classrooms and struggle with organization, time management, and planning (OTMP) skills. They must be nominated by a teacher due to OTMP skill deficits affecting their academic performance. Parental consent and student assent are required. Students with one-to-one aides, those mostly in special education, non-English speaking families, or from families already participating are excluded.

Inclusion Criteria

SCHOOL PROVIDERS: School providers capable of delivering the HOPS intervention chosen by school administrators

PARENTS: The parent/legal guardian's child is eligible for the study

I am a middle school student nominated for extra help due to skills affecting my grades.

Exclusion Criteria

PARENTS: Parents who are not fluent in English

SCHOOL PROVIDERS: Any school professional who declines to participate

RESEARCH PROVIDERS: Does not consent to be a 'secondary research participant'

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

The HOPS intervention is delivered through 16 sessions focusing on organization, homework management, and time management skills.

5 school months

16 sessions (in-person)

Follow-up

Participants are monitored for changes in organizational skills and academic performance.

12 calendar months

Extension

Participants in the Treatment-As-Usual Waitlist receive the HOPS intervention after initial data collection.

Varies

What Are the Treatments Tested in This Trial?

Interventions

• HOPS Intervention

Trial Overview The HOPS Study tests the Homework, Organization, and Planning Skills intervention under normal school conditions with school staff as interventionists. It aims to replicate previous findings on its efficacy for improving students' organizational skills and will also examine how well the program is implemented.

How Is the Trial Designed?

Group I: Homework, Organization, and Planning Skills (HOPS) Experimental Treatment 1 Intervention

The Homework, Organization, and Planning Skills (HOPS) intervention is delivered through a series of 16 frequent but brief sessions between the HOPS provider and student. The HOPS intervention will be delivered by either a member of the school team (HOPS-ST), referred to as a "school provider", or a member of the research team (HOPS-RT), referred to as a "research provider". Each session is approximately 20 minutes. The three main skill areas covered as part of the program are: (1) school materials organization, (2) homework management and (3) time management and planning. A reward system is utilized in effort to change behavior patterns by making rewards available when a student engages in productive organizing and planning behaviors. The intervention also includes two parent meetings and one teacher meeting.

Group II: Treatment-As-Usual Waitlist (WL-TAU) Active Control 1 Intervention

The Treatment-As-Usual Waitlist (WL-TAU) will be enacted for study participants attending the enrolled schools assigned to this arm. After providing post data (and in some cases, follow-up data as well), participants will then receive the HOPS intervention.

HOPS Intervention is already approved in United States for the following indications:

Approved in United States as HOPS Intervention for:

• Improvement in organization and time-management skills for students with ADHD and other difficulties

Who Is Running the Clinical Trial?

Children's Hospital of Philadelphia

Lead Sponsor

Trials

749

Recruited

11,400,000+

Rutgers University

Collaborator

Trials

127

Recruited

2,814,000+

University of Pennsylvania

Collaborator

Trials

2,118

Recruited

45,270,000+

Virginia Commonwealth University

Collaborator

Trials

732

Recruited

22,900,000+

U.S. Department of Education

Collaborator

Trials

87

Recruited

54,500+

Published Research Related to This Trial

A study involving 280 middle school students with ADHD found that two brief school-based interventions, HOPS and CHIEF, significantly improved homework problems and organizational skills compared to a waitlist group, with large effect sizes.

The HOPS intervention was particularly effective for students with more severe ADHD symptoms, showing greater improvements in organized actions compared to CHIEF, suggesting that tailored interventions can enhance outcomes for students with varying levels of need.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overcoming the research-to-practice gap: A randomized trial with two brief homework and organization interventions for students with ADHD as implemented by school mental health providers. Langberg, JM., Dvorsky, MR., Molitor, SJ., et al.[2020]

The HOPS intervention significantly improved organizational skills and homework completion behaviors in middle school students with ADHD, as reported by parents, with effect sizes indicating strong improvements (e.g., planning d = 1.05).

Despite these positive outcomes from parent ratings, teachers did not report significant improvements in the students' organizational skills, suggesting a discrepancy between home and school environments in the effectiveness of the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the Homework, Organization, and Planning Skills (HOPS) Intervention for Middle School Students with ADHD as Implemented by School Mental Health Providers. Langberg, JM., Epstein, JN., Becker, SP., et al.[2019]

Organizational skills training interventions for children and adults with ADHD have shown significant improvements in managing time and materials, which can help reduce symptoms and enhance academic performance.

While these interventions are promising, further research with randomized controlled trials and long-term follow-ups is needed to establish them as evidence-based treatments for ADHD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Organizational-skills interventions in the treatment of ADHD. Langberg, JM., Epstein, JN., Graham, AJ.[2018]

The HOPS intervention led to significant improvements in organization skills (effect size d = 1.8) and homework management (d = 1.6) as reported by parents of 11 middle school students with ADHD, indicating its potential efficacy.

Despite positive parent feedback, teachers did not report similar improvements, highlighting a need for further refinement of the intervention to enhance its effectiveness in school settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Refinement of an Organizational Skills Intervention for Adolescents with ADHD for Implementation by School Mental Health Providers. Langberg, JM., Vaughn, AJ., Williamson, P., et al.[2021]

The group parenting intervention program for children at risk of ADHD did not show significant improvement in core ADHD symptoms, as measured by the ADHD index, after 6 months.

However, the combined intervention showed a potential reduction in parent-reported hyperactivity symptoms and the parent-only intervention improved parental mental health, suggesting some secondary benefits from the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and cost-effectiveness of a brief school-based group programme for parents of children at risk of ADHD: a cluster randomised controlled trial. Sayal, K., Taylor, JA., Valentine, A., et al.[2017]

The Collaborative Life Skills (CLS) program provides a comprehensive intervention for children with ADHD, involving training for teachers, parents, and children over 10 to 12 weeks to improve academic and social outcomes.

Booster treatments in subsequent school years are essential for maintaining the benefits of the initial intervention, highlighting the need for ongoing support to prevent long-term negative impacts on education and social relationships.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting Success Across School Years for Children With Attention-Deficit/Hyperactivity Disorder: Collaborative School-Home Intervention. DuPaul, GJ.[2019]

The Challenging Horizons Program (CHP) adapted for high school students with ADHD showed significant improvements in organization skills and homework performance, with small to medium effect sizes observed at a 6-month follow-up involving 186 adolescents.

While CHP helped protect against a decline in report card grades compared to community care, the overall effect on grades was small, suggesting that additional academic skills instruction may be necessary for some students.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

School-based intervention for adolescents with attention-deficit/hyperactivity disorder: Effects on academic functioning. DuPaul, GJ., Evans, SW., Owens, JS., et al.[2021]

The HOPS intervention significantly improved organizational and planning skills in 23 middle school students with ADHD, as reported by parents, indicating its efficacy in addressing homework and organization problems.

The use of a structured binder organization system was a key predictor of success, showing that teaching students specific organizational skills can lead to better outcomes, independent of other factors like therapeutic alliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of Response and Mechanisms of Change in an Organizational Skills Intervention for Students with ADHD. Langberg, JM., Becker, SP., Epstein, JN., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4209597/

Evaluation of the Homework, Organization, and Planning ... The purpose of the study was to evaluate the Homework, Organization, and Planning Skills (HOPS) intervention for middle school students with Attention-Deficit/ ...

2. ies.ed.gov ies.ed.gov/use-work/awards/evaluation-homework-organization-and-planning-skills-program-conceptual-replication

Evaluation of Homework, Organization, and Planning Skills ... In this study, an independent research team will test whether HOPS yields similar benefits under routine practice conditions for the full range of students who ...

3. ies.ed.gov ies.ed.gov/use-work/awards/efficacy-organizational-skills-intervention-middle-school-students-adhd

Efficacy of an Organizational Skills Intervention for Middle ... HOPS also provided greater benefits overall for students with higher levels of hyperactivity and oppositional behavior and greater deficits in organizational ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3627380/

Refinement of an Organizational Skills Intervention for ... The purpose of the study was to modify, test, and refine the Homework, Organization, and Planning Skills (HOPS) intervention for adolescents with ADHD.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0005789418300558

Predictors and Trajectories of Response to the Homework ... HOPS intervention skills are differentially associated with outcomes · Homework recording and time management most strongly associated with parent ratings.

6. hopsintervention.com hopsintervention.com/

Homework, Organization and Planning Skills (HOPS) – A ... HOPS intervention has been evaluated in multiple randomized trials and found to be effective for middle school students diagnosed with Attention-Deficit/ ...

7. withpower.com withpower.com/trial/phase-attention-deficit-disorder-with-hyperactivity-7-2021-e5555

HOPS Intervention for ADHD The available research on the HOPS Intervention for ADHD, which focuses on improving homework and organizational skills in students, does not report any safety ...