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Organizational Skills Interventions for Children With Attention Deficit Hyperactivity Disorder (ADHD)

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Homework, Organization, and Planning Skills (HOPS) Intervention
Sponsored by
Children's Hospital Medical Center, Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring ADHD, School-Based, Organizational Skills, Homework, Time Management

Eligibility Criteria

11 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Middle school age adolescents (grades 6-8) who meet Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for a diagnosis of ADHD.

Exclusion Criteria:

  • Cognitive Functioning: Full scale IQ score of less than 75.
  • Exclusionary Psychiatric Conditions: Students who meet diagnostic criteria for Bipolar Disorder, psychotic disorder, pervasive developmental disorders, substance dependence, or obsessive-compulsive disorder be excluded from participation.

Sites / Locations

  • Cincinnati Children's Hospital Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

HOPS Intervention

Treatment As Usual

Arm Description

Middle school age children who receive the Homework, Organization, and Planning Skills (HOPS) intervention.

Middle school age children randomly assigned to receive treatment-as-usual services available through the school and community.

Outcomes

Primary Outcome Measures

Homework Problems Checklist
Parent completed measure that assesses homework completion difficulties and homework management difficulties.

Secondary Outcome Measures

Children's Organizational Skills Scales (COSS)
Parent, child, and teacher completed measure that evaluates organization and time-management/planning skills.

Full Information

First Posted
July 12, 2010
Last Updated
July 29, 2013
Sponsor
Children's Hospital Medical Center, Cincinnati
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1. Study Identification

Unique Protocol Identification Number
NCT01176136
Brief Title
Organizational Skills Interventions for Children With Attention Deficit Hyperactivity Disorder (ADHD)
Official Title
Organizational Skills Interventions for Children With ADHD
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Attention-Deficit/Hyperactivity Disorder (ADHD) is one of the most commonly diagnosed childhood disorders, with prevalence rates estimated at 8% (Froehlich et al. 2007). Several of the primary symptoms of ADHD relate to problems with temporal and materials organization (i.e. often has difficulty organizing tasks and activities, often loses things, is often forgetful, and often fails to finish school-work, chores, or duties; APA, 2000). In the school setting, problems with organization manifest as forgetting to complete or losing homework assignments, difficulties planning for the completion of long-term projects and studying for tests, and problems keeping class materials organized. These organizational difficulties become particularly problematic in middle school and can result in considerable academic impairment (Evans, Serpell, & White, 2005). Children with ADHD underachieve academically and are more likely than their peers to receive failing grades, be retained and to drop out of school (Barkley, Fischer, Edelbrock, & Smallish, 1990). Given the relationship between temporal and materials organization and poor school performance, it is clear there is a need for interventions to address these difficulties. We recently sought to address this need by completing a small randomized trial of an organizational skills intervention for children with ADHD (Langberg, Epstein, Urbanowicz, Simon, & Graham, (2008). The intervention was highly effective in improving materials organization and homework management and resulted in significant improvements in homework problems and grade point average. These results demonstrate the considerable promise of organizational skills interventions for children with ADHD. However, the Langberg et al. intervention was implemented as an after-school program operated by research staff with minimal involvement from school personnel. In order to promote the widespread adoption of interventions that address the organizational skills deficits of children with ADHD, the intervention must be feasible for school counselors and psychologists to implement within the time constraints of a typical school day. Accordingly, the primary goal of this study is to adapt and refine the existing intervention protocol (Langberg et al., 2008) to create a product that is highly acceptable to parents, children, teachers, school counselors and school psychologists and is feasible for school personnel to implement during the school day. In Phase I of the proposed research, middle school counselors, psychologists, teachers, middle school students with ADHD and their parents will consult with the intervention developers to modify the after-school treatment protocol for in-school implementation. An intervention protocol will be developed. The intervention will be piloted with ten children in order to identify barriers to implementation. Measures of treatment fidelity, skills acquisition, and satisfaction will be completed. These data will inform additional modifications of the protocol and further improve feasibility/acceptability of the intervention procedures. In Phase II of the study, school counselors/psychologists from at least four separate school districts will implement the protocol developed in Phase I. Using a waitlist control design, sixty children with ADHD in grades 6, 7, and 8 will receive the intervention. Organizational skills, grade point average, and academic impairment will be evaluated at baseline, post intervention and at 8-week follow-up. After implementing the intervention, all participants (i.e., teachers, counselors, psychologists, children and parents) will participate in a series of focus groups and will complete intervention satisfaction questionnaires. These data will inform final revisions to the intervention protocol. The resulting product will be an intervention that targets organizational skills in children with ADHD that has potential for widespread school-based dissemination. The final intervention protocol and effect size estimates from the proposed research will lay the foundation for an IES Goal III test of efficacy. The specific aims of the project are as follows: Utilize the existing organizational skills intervention protocol (Langberg et al. in press), focus group and case study data to develop an empirically and clinically informed manualized temporal and materials organization intervention for middle school children with ADHD aimed at reducing academic impairment (Phase I). Refine and finalize the intervention protocol through a waitlist control trial (N=60) in a minimum of four diverse school districts, collection of clinical outcomes and completion of follow-up focus groups to assess satisfaction, feasibility, and acceptability (Phase II).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
ADHD, School-Based, Organizational Skills, Homework, Time Management

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HOPS Intervention
Arm Type
Experimental
Arm Description
Middle school age children who receive the Homework, Organization, and Planning Skills (HOPS) intervention.
Arm Title
Treatment As Usual
Arm Type
No Intervention
Arm Description
Middle school age children randomly assigned to receive treatment-as-usual services available through the school and community.
Intervention Type
Behavioral
Intervention Name(s)
Homework, Organization, and Planning Skills (HOPS) Intervention
Intervention Description
HOPS is a 16 session school-based intervention. School counselors and psychologists deliver the intervention during the school day. Each session lasts 20 minutes. Initially, sessions are 2 times per week and the entire HOPS intervention is completed in 11 weeks. The study uses a waitlist control design. HOPS intervention participants (Arm 1) receive the intervention in the fall quarter of the school year and Treatment As Usual participants (Arm 2) receive the intervention in the spring quarter.
Primary Outcome Measure Information:
Title
Homework Problems Checklist
Description
Parent completed measure that assesses homework completion difficulties and homework management difficulties.
Time Frame
8 months post-baseline
Secondary Outcome Measure Information:
Title
Children's Organizational Skills Scales (COSS)
Description
Parent, child, and teacher completed measure that evaluates organization and time-management/planning skills.
Time Frame
8-months post-baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Middle school age adolescents (grades 6-8) who meet Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for a diagnosis of ADHD. Exclusion Criteria: Cognitive Functioning: Full scale IQ score of less than 75. Exclusionary Psychiatric Conditions: Students who meet diagnostic criteria for Bipolar Disorder, psychotic disorder, pervasive developmental disorders, substance dependence, or obsessive-compulsive disorder be excluded from participation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua M Langberg, PhD
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229-3039
Country
United States

12. IPD Sharing Statement

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Organizational Skills Interventions for Children With Attention Deficit Hyperactivity Disorder (ADHD)

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