HOPS Study: A Conceptual Replication (NCT04465708) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
HOPS Study: A Conceptual Replication
United States240 participantsStarted 2021-10-25
Plain-language summary
The purpose of this current study is to conduct a conceptual replication with an independent evaluation team of the randomized controlled trial conducted by Langberg and colleagues, which demonstrated the efficacy of the Homework, Organization, and Planning Skills (HOPS) intervention. The study will be conducted under routine practice conditions with school staff serving as interventionists; the study sample will include the broad range of students with organization, time management, and planning problems. The study will examine how implementation factors (fidelity, engagement, working alliance) are related to outcomes, and it will explore the potential moderating role of school organization factors on outcomes.
Who can participate
Age range
11 Years – 15 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female students in grades 6 through 8.
. Student is in a general education classroom.
. Student is nominated for the study by at least one teacher(s) who rates the student as needing the intervention and having OTMP skills deficits that have a negative impact on academic performance (rating \> 3 on a 4-point scale on at least one of four interference items of COSS-T)
. Parental/guardian permission (informed consent) and student assent.
. A person with experience providing instruction or intervention to students in a school context.
. A member of the research team who will provide the HOPS intervention to the HOPS-RT condition
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Student Functioning at Home
Timeframe: Baseline, 4 calendar months after baseline, 6 school months after baseline, 12 calendar months after baseline
2
Change in Student Functioning at School
Timeframe: Baseline, 4 calendar months after baseline, 5 school months after baseline, 12 calendar months after baseline
. Has consented to be a "secondary research participant"
Exclusion criteria
. Students will be excluded if they are in a pull-out special education classroom for more than 50% of the day, because the organizational demands for these students may differ from those placed mostly in general education.
. Students with a one-to-one aide will be excluded because the presence of an aide substantially alters how an organizational intervention is implemented.
. Students from families in which both caregivers do not speak English will be excluded because the program has not yet been developed for non-English speakers.
. Students who may have participated in HOPS before (as it is a commercially-available program) is not eligible to participate in this study.
. Parents who are not fluent in English are excluded since at this time because the intervention and many of the study outcome measures are not available in other languages.