Clinical trial NCT04465708: HOPS Study: A Conceptual Replication
Official title: Evaluation of Homework, Organization, and Planning Skills (HOPS) Program: A Conceptual Replication
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Executive Dysfunction
Attention Deficit Hyperactivity Disorder
Keywords: organizational skills
middle school
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: University of Pennsylvania
name: U.S. Department of Education
name: Rutgers University
First posted: 2020-07-10
Enrollment: 240
Sex: ALL
Minimum age (years): 11
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

STUDENTS

1. Male or female students in grades 6 through 8.
2. Student is in a general education classroom.
3. 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)
4. Parental/guardian permission (informed consent) and student assent.

PARENTS

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

1. A person with experience providing instruction or intervention to students in a school context.
2. A member of the research team who will provide the HOPS intervention to the HOPS-RT condition
3. Has consented to be a "secondary research participant"

Exclusion Criteria:

STUDENTS

1. 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.
2. Students with a one-to-one aide will be excluded because the presence of an aide substantially alters how an organizational intervention is implemented.
3. 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.
4. Students who may have participated in HOPS before (as it is a commercially-available program) is not eligible to participate in this study.

PARENTS

1. 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"

Primary outcomes:
measure: Change in Student Functioning at Home
timeFrame: Baseline, 4 calendar months after baseline, 6 school months after baseline, 12 calendar months after baseline
measure: Change in Student Functioning at School
timeFrame: Baseline, 4 calendar months after baseline, 5 school months after baseline, 12 calendar months after baseline
Secondary outcomes:
measure: Change in Student Proficiency in Academic Subject Areas
timeFrame: Baseline, 4 calendar months after baseline, 5 school months after baseline, 12 calendar months after baseline
measure: Change in Student Academic Grades
timeFrame: End of school year prior to year of enrollment, end of school year of enrollment, end of school year after year of enrollment
measure: Change in Student Homework Performance at Home
timeFrame: Baseline, 4 calendar months after baseline, 5 school months after baseline, 12 calendar months after baselinee
measure: Change in Student Homework Competence at School
timeFrame: Baseline, 4 calendar months after baseline, 5 school months after Baseline, 12 calendar months after baseline
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Thomas Power, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital of Philadelphia
name: Jenelle Nissley-Tsiopinis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.