HOPS Study: A Conceptual Replication

Children's Hospital of Philadelphia (CHOP)

Status: Enrolling

Conditions: Attention Deficit Hyperactivity Disorder; Executive Dysfunction

Treatments: Behavioral: Homework, Organization, and Planning Skills

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT04465708

19-016865

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 estimated patients

Sex: All

Ages: 11 to 15 years old

Volunteers: Accepts Healthy Volunteers

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"

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 2 patient groups

Homework, Organization, and Planning Skills (HOPS)

Other group

Description:

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.

Treatment:

Behavioral: Homework, Organization, and Planning Skills

Treatment-As-Usual Waitlist (WL-TAU)

No Intervention group

Description:

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.