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

NCT01176136 | Completed DMC

• 2 other identifiers: 2009-0479R305A090305
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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:

1. 1.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).
2. 2.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).

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ADHD; School-Based; Organizational Skills; Homework; Time Management

Outcome Measures

Primary Outcomes (1)

• Homework Problems Checklist

  Parent completed measure that assesses homework completion difficulties and homework management difficulties.

  8 months post-baseline

Secondary Outcomes (1)

• Children's Organizational Skills Scales (COSS)

  8-months post-baseline

Study Arms (2)

HOPS Intervention

EXPERIMENTAL

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

Behavioral: Homework, Organization, and Planning Skills (HOPS) Intervention

Treatment As Usual

NO INTERVENTION

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

Interventions

Homework, Organization, and Planning Skills (HOPS) Intervention BEHAVIORAL

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.

HOPS Intervention

Eligibility Criteria

• Age: 11 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Cognitive Functioning: Full scale IQ score of less than 75.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229-3039, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Organizations; ALPL protein, human; Methods

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Health Care Economics and Organizations; Investigative Techniques

Study Officials

• Joshua M Langberg, PhD

  Children's Hospital Medical Center, Cincinnati

  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: July 12, 2010
• First Posted: August 5, 2010
• Study Start: September 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2013
• Last Updated: July 30, 2013

Record last verified: 2013-07

Locations

US (1)