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Executive DysfunctionNCT04465708

HOPS Study: A Conceptual Replication

A study testing Homework, Organization, and Planning Skills in people with Executive Dysfunction and Attention Deficit Hyperactivity Disorder, run by Children's Hospital of Philadelphia at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 11 to 15 yearsHealthy volunteers can take part
What is being tested?
Homework, Organization, and Planning Skills
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
1 siteUnited States
Study dates
25 Oct 2021to 30 Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 11 to 15 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • STUDENTS
  • 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.
  • PARENTS
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  • 1. The parent/legal guardian's child is eligible for the study
  • SCHOOL PROVIDERS
  • 1. School providers will be chosen by school administrators as personnel who are capable of delivering the HOPS intervention (HOPS-ST) in the school context.
  • RESEARCH PROVIDER
  • 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
  • Has consented to be a "secondary research participant"

Who cannot join

  • STUDENTS
  • 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
Show all 11Show fewer
  • 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.
  • SCHOOL PROVIDERS
  • 1. Any school professional who declines to participate will not be enrolled.
  • RESEARCH PROVIDERS
  • 1. Does not consent to be a "secondary research participant"

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19146

Other trials in United States

About this study

Official title: Evaluation of Homework, Organization, and Planning Skills (HOPS) Program: A Conceptual Replication

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.

Read the detailed description

Organization, time management, and planning (OTMP) skills are associated with academic performance. A randomized controlled trial found that the Homework, Organization, and Planning Skills (HOPS) intervention was effective in improving student organization skills and homework performance, with moderate to large effect sizes. HOPS is a 16-session skills training program, provided individually to students in grades 6 through 8 who have OTMP skills deficits that contribute to academic difficulties. Two parent consultations and one teacher consultation promote generalization and maintenance of effects. The current study is a conceptual replication of the previous HOPS study, conducted by an independent evaluation team. The intervention will be delivered under routine practice conditions, with school staff serving as interventionists. The study will examine how fidelity, engagement, and working alliance are related to outcomes, and it will explore the extent to which school organization factors moderate outcomes. Across 30 schools in Pennsylvania and New Jersey, Investigators will recruit a total of 240 6th, 7th, and 8th grade students with OTMP deficits. Parents and teachers provide data about the students. School counselors, Principals, and an Individualized Education Plan (IEP)/504 Plan Case Manager may provide data about the organizational context of the schools. The intervention is provided individually to students by a member of the school staff or a member of the research team.

Using a cluster randomized design, Investigators will randomize schools to HOPS or Treatment as Usual - Wait List (TAU-WL), ratio of 2:1. In HOPS schools, students will be randomly assigned to receive intervention by school providers (HOPS-ST) or by research team providers (HOPS-RT). Outcomes will be assessed at Baseline and Post-Treatment period for all students, at 5 school months after Baseline assessment for all students in the HOPS condition, and at 12 calendar months after Baseline for students who are in the HOPS condition and who stay in the same school into the following academic year. Participants in TAU-WL will receive HOPS following Post-Treatment data collection. Participants in TAU-WL will be evaluated again a third time with an abridged battery after they receive HOPS.

Being tested
Homework, Organization, and Planning Skills
Keywords
organizational skills, middle school
Medical subject headings
Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Homework, Organization, and Planning SkillsBehavioural

    Also called HOPS

    HOPS is a 16-session, skills training program, provided individually to students in grades 6 through 8 who have OTMP skills deficits that contribute to academic difficulties. HOPS includes two parent consultations and one teacher consultation to promote generalization and maintenance of effects.

Study groups in NCT04465708
Study groupRoleWhat they receive
Homework, Organization, and Planning Skills (HOPS)OtherThe 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.
Receives: Behavioral: Homework, Organization, and Planning Skills
Treatment-As-Usual Waitlist (WL-TAU)No interventionThe 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Student Functioning at Home

    The Children's Organizational Skills Scale - Parent version (COSS-P) will be used to assess changes in OTMP functioning at home. COSS-P total scores have good discriminant validity and are sensitive to treatment effects. The COSS-P uses a 4-point rating scale (1=Hardly ever or never to 4=Just about all of the time). The COSS-P yields three subscale scores: Materials Management, Organized Actions, and Task Planning. Minimum scores for each subscale and the Total score are 40 and maximum scores are 90, with higher scores representing more impairment. The COSS-P will be used primarily as an outcome measure. In addition, Investigators will examine whether severity of organization problems, as measured by Baseline COSS-P scores, moderates the effect of treatment on academic outcomes.

    Measured: Baseline, 4 calendar months after baseline, 6 school months after baseline, 12 calendar months after baseline

  2. Change in Student Functioning at School

    The Children's Organizational Skills Scale - Teacher version (COSS-T) will be used to assess changes in OTMP functioning at school. COSS total scores have good discriminant validity and are sensitive to treatment effects. The COSS-T uses a 4-point rating scale (1=Hardly ever or never to 4=Just about all of the time). The COSS-T yields three subscale scores: Materials Management, Organized Actions, and Task Planning. Minimum scores for each subscale and the Total score are 40 and maximum scores are 90, with higher scores representing more impairment. The COSS-T will be used primarily as an outcome measure. In addition, Investigators will examine whether severity of organization problems, as measured by Baseline COSS-T scores, moderates the effect of treatment on academic outcomes.

    Measured: Baseline, 4 calendar months after baseline, 5 school months after baseline, 12 calendar months after baseline

Secondary outcomes (5)

  1. Change in Student Proficiency in Academic Subject Areas

    The Academic Progress Report (APR) is a teacher-report measure that assesses proficiency in up to six academic subjects relative to standard expectations (1=Well below standard expected at this time of year; 3=At standard; 5=Well above standard). The sum of ratings across six academic subjects is the unit of analysis. The minimum score is 1 and the maximum score is 5, with higher scores indicating higher functioning. Reliability is acceptable (alpha = .84), and this measure is sensitive to treatment effects for an elementary school organizational skills training intervention. For each participating student, Investigators will obtain teacher ratings on the APR from two of the student's academic teachers to attempt to capture the student's academic performance in a standardized fashion.

    Measured: Baseline, 4 calendar months after baseline, 5 school months after baseline, 12 calendar months after baseline

  2. Change in Student Academic Grades

    Investigators will obtain report card grades for the academic year prior to student enrollment, the academic year of student enrollment, and the academic year following student enrollment for all participating students. Investigators will calculate students' grade point average based on report card grades.

    Measured: End of school year prior to year of enrollment, end of school year of enrollment, end of school year after year of enrollment

  3. Change in Student Homework Performance at Home

    The Homework Problem Checklist (HPC) is a 20-item parent-report measure that assesses student homework performance. Factor analyses conducted by Power and Langberg et al., have indicated that the HPC has two distinct factors: Homework Completion and Homework Materials Management. Scores range from a minimum of 0 to a maximum of 60, with higher scores representing higher impairment. The HPC has been shown to be sensitive to the effects of interventions to improve student homework and organization skills.

    Measured: Baseline, 4 calendar months after baseline, 5 school months after baseline, 12 calendar months after baselinee

  4. Change in Student Homework Competence at School

    The Homework Performance Questionnaire - Teacher Revised Version (HPQ-T) assesses students' homework behavior during the past 4 weeks. Each item is rated on a 7-point scale indicating how often each behavior occurs (never or rarely = 0% to 10% of time; almost always/always = 91% to 100% of time). The 17-item General factor that assesses overall homework competence, which has strong psychometric properties, will be used in the analyses. This score is generated by averaging the scores of items 9-25, with a minimum score of 0 and a maximum score of 6. Higher scores indicate higher functioning.

    Measured: Baseline, 4 calendar months after baseline, 5 school months after Baseline, 12 calendar months after baseline

  5. Progress monitoring of organization skills

    Children's Organizational Skills Scale (COSS) Screening and Direct Behavior Rating Form (caregiver and teacher versions). This measure (both versions) has 10 items that are scored on a 6-point scale (0=never; 5=all the time). With reverse scoring of some items, higher scores reflect greater organizational skills deficits. The measure yields a Total Score, score on a standard set of five formative assessment items, and a score on a hybrid version consisting of three core items and two individualized items indicating major areas of deficit at baseline. These measures have been validated for use in formative assessment (progress monitoring) by our research team.

    Measured: For students enrolled in the 2025-26 school year only, the measure will be administered to caregivers and teachers weekly for about 4 weeks (until four forms are completed) and biweekly for about 12 weeks (until the end of the intervention period.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2020
  2. Study start25 Oct 2021
  3. Primary completion31 May 2027 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04465708
Sponsor's protocol ID
19-016865
Status last verified
Apr 2026
First submitted
30 Jun 2020
Last updated
15 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data pertaining to study variables included in analyses of study aims.

Publications

  • Langberg JM, Becker SP, Epstein JN, Vaughn AJ, Girio-Herrera E. Predictors of Response and Mechanisms of Change in an Organizational Skills Intervention for Students with ADHD. J Child Fam Stud. 2013 Oct 1;22(6):10.1007/s10826-012-9662-5. doi: 10.1007/s10826-012-9662-5.

    PubMed 24319323

  • Langberg JM, Dvorsky MR, Molitor SJ, Bourchtein E, Eddy LD, Smith ZR, Oddo LE, Eadeh HM. 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. J Consult Clin Psychol. 2018 Jan;86(1):39-55. doi: 10.1037/ccp0000265. Epub 2017 Nov 27.

    PubMed 29172596

  • Abikoff H, Gallagher R, Wells KC, Murray DW, Huang L, Lu F, Petkova E. Remediating organizational functioning in children with ADHD: immediate and long-term effects from a randomized controlled trial. J Consult Clin Psychol. 2013 Feb;81(1):113-28. doi: 10.1037/a0029648. Epub 2012 Aug 13.

    PubMed 22889336

  • Pfiffner LJ, Villodas M, Kaiser N, Rooney M, McBurnett K. Educational outcomes of a collaborative school-home behavioral intervention for ADHD. Sch Psychol Q. 2013 Mar;28(1):25-36. doi: 10.1037/spq0000016.

    PubMed 23506023

  • Langberg JM, Arnold LE, Flowers AM, Altaye M, Epstein JN, Molina BS. Assessing Homework Problems in Children with ADHD: Validation of a Parent-Report Measure and Evaluation of Homework Performance Patterns. School Ment Health. 2010 Mar 1;2(1):3-12. doi: 10.1007/s12310-009-9021-x.

    PubMed 21544228

  • Power TJ, Mautone JA, Soffer SL, Clarke AT, Marshall SA, Sharman J, Blum NJ, Glanzman M, Elia J, Jawad AF. A family-school intervention for children with ADHD: results of a randomized clinical trial. J Consult Clin Psychol. 2012 Aug;80(4):611-23. doi: 10.1037/a0028188. Epub 2012 Apr 16.

    PubMed 22506793

  • Nissley-Tsiopinis J, Fleming PF, Chan W, Langberg JM, Cacia J, Vigil T, Chamberlin B, Di Bartolo CA, Tremont KL, Walz EH, Jawad AF, Mautone JA, Power TJ. Cluster-randomized trial of Homework, Organization, and Planning Skills program compared to treatment as usual/waitlist for youth ages 11-14: Study protocol for conceptual replication. PLoS One. 2026 Jun 11;21(6):e0343894. doi: 10.1371/journal.pone.0343894. eCollection 2026.

    PubMed 42275393

Questions about this trial

What is this clinical trial studying?

A study testing Homework, Organization, and Planning Skills in people with Executive Dysfunction and Attention Deficit Hyperactivity Disorder, run by Children's Hospital of Philadelphia at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Student Functioning at Home (time frame: Baseline, 4 calendar months after baseline, 6 school months after baseline, 12 calendar months after baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04465708, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.

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