HOPS Study: A Conceptual Replication

NCT04465708 | Active Not Recruiting

• 1 other identifier: 19-016865
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Executive Dysfunction; Attention Deficit Hyperactivity Disorder

Keywords

organizational skills; middle school

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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.

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

Secondary Outcomes (5)

• Change in Student Proficiency in Academic Subject Areas

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

• Change in Student Academic Grades

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

• Change in Student Homework Performance at Home

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

• Change in Student Homework Competence at School

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

• Progress monitoring of organization skills

  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.

Study Arms (2)

Homework, Organization, and Planning Skills (HOPS)

OTHER

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.

Behavioral: Homework, Organization, and Planning Skills

Treatment-As-Usual Waitlist (WL-TAU)

NO 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.

Interventions

Homework, Organization, and Planning Skills BEHAVIORAL

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.

Also known as: HOPS

Homework, Organization, and Planning Skills (HOPS)

Eligibility Criteria

• Age: 11 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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
• \. The parent/legal guardian's child is eligible for the study
• SCHOOL PROVIDERS
• \. 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"

You may not qualify if:

• 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
• 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
• \. Any school professional who declines to participate will not be enrolled.
• RESEARCH PROVIDERS
• \. Does not consent to be a "secondary research participant"

Sponsors & Collaborators

• Rutgers University: collaborator
• Children's Hospital of Philadelphia: lead
• University of Pennsylvania: collaborator
• U.S. Department of Education: collaborator

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19146, United States

Location

Related Publications (6)

• 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.

  PMID: 24319323 BACKGROUND

• 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.

  PMID: 29172596 BACKGROUND

• 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.

  PMID: 22889336 BACKGROUND

• 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.

  PMID: 23506023 BACKGROUND

• 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.

  PMID: 21544228 BACKGROUND

• 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.

  PMID: 22506793 BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Organizations

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Health Care Economics and Organizations

Study Officials

• Thomas Power, PhD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

• Jenelle Nissley-Tsiopinis, PhD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2020
• First Posted: July 10, 2020
• Study Start: October 25, 2021
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will become accessible after the study is completed and primary study findings are published in a peer-reviewed journal. Data will be available for 10 years from that time.
• Access Criteria: When our research team receives a request for access to the data, a data file and supporting documentation will be prepared by the research team. Only de-identified data will be made accessible in order to prevent identification of students, parents, and school staff who participated in this project. Per Children's Hospital of Philadelphia (CHOP) policies, a data use agreement is necessary prior to sharing data. A brief verbal progress report related to a particular student participant will be shared with school professionals with the consent of the parent or legal guardian.

Locations

US (1)