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Comparing School Based Interventions for Adolescents With Attention Deficit Hyperactivity Disorder

Primary Purpose

Attention Deficit Disorder With Hyperactivity

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Challenging Horizons Program (CHP) after-school model
Challenging Horizons Program (CHP) consultation model
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 Disorder With Hyperactivity focused on measuring Attention Deficit Hyperactivity Disorder, ADHD, School Based, Intervention, Psychosocial, Academic Intervention, Behavioral

Eligibility Criteria

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

Inclusion Criteria:

  • Meets DSM-IV criteria for ADHD, including all ADHD subtypes (predominately inattentive, predominately hyperactive/impulsive, and combined)
  • All common comorbid conditions not listed as exclusionary will be included.

Exclusion Criteria:

  • Full Scale Intelligence Quotient (FSIQ) less than 80
  • Anticipated attendance for participant or parent less than 80% for scheduled activities
  • Meets diagnostic criteria for bipolar disorder, psychotic disorder, substance dependence (but not substance abuse), or obsessive-compulsive disorder (OCD)

Sites / Locations

  • Ohio University
  • Cincinnati Children's Hospital Medical Center, Center for ADHD

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Challenging Horizons Program after-school model

Challenging Horizons Program consultation model

Community care

Arm Description

Participants will receive the CHP after-school model.

Participants will receive the CHP consultation model.

Participants will have access to standard community care.

Outcomes

Primary Outcome Measures

Teacher ratings of academic performance on the Impairment Rating Scale

Secondary Outcome Measures

Grade point average (GPA)

Full Information

First Posted
July 27, 2009
Last Updated
December 15, 2016
Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00947973
Brief Title
Comparing School Based Interventions for Adolescents With Attention Deficit Hyperactivity Disorder
Official Title
Multisite Study of School Based Treatment Approaches for ADHD Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will compare the efficacy and cost effectiveness of two methods of treating adolescents with attention deficit hyperactivity disorder in school.
Detailed Description
Attention deficit hyperactivity disorder (ADHD) is characterized by inattention, hyperactivity, and impulsivity. Approximately 50% to 70% of children who had ADHD continue to meet its criteria in adolescence, but the problems stemming from adolescent ADHD can be more serious-including an increased risk of substance use, delinquency, academic failure, serious social impairment, and legal problems. Problems in school more than double when students with ADHD move from elementary school to middle and high school. Treating ADHD with medications alone is often ineffective, but adding other methods, such as behavioral treatments, may be beneficial. Researchers have developed a psychosocial treatment for adolescents with ADHD, called the Challenging Horizons Program (CHP), that is delivered in school and targets social impairment, family conflict, and academic failure. Two versions of CHP were developed, an after-school model and a consultation model. The after-school model involves 2 to 3 days of individualized treatment per week and has a higher cost than the consultation model because it involves hiring specialized counseling staff and finding space to house the program after school. The consultation model involves teaching CHP intervention strategies to school staff, who then mentor students with ADHD and deliver interventions as needed to solve problems. This model is less expensive, but it does not deliver treatment as often or consistently as the after-school model. This study will compare the after-school and consultation models of the CHP to determine their relative efficacy and cost effectiveness. The study will also evaluate factors that may predict which adolescents would benefit most from either of the two models. Participation in this study will last a full school year. Participants from schools taking part will be randomly assigned to one of three groups: after-school CHP, consultation CHP, or standard community care. Participants receiving after-school CHP will attend two 2.5-hour after-school sessions per week in which they will work with counselors on homework management, educational skills, and interpersonal skills. Participants receiving consultation CHP will be assigned a teacher mentor (who will volunteer to work with the student), and the mentor and student will meet as needed. A study clinician will provide support to the teacher mentors, who will learn the same interventions as counselors in the after-school condition. Participants in the community care condition will not receive any intervention but will receive a list of community psychosocial and medical service providers for children and their families. All participants will undergo study assessments pre-treatment; in November, January, and March of the school year; post-treatment; and at a 6-month follow-up. Assessments will include questionnaires and clinical interviews completed by student, their parents, and their teachers. ADHD symptoms, academic performance, relevant skills of adolescents, and program costs will be assessed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Disorder With Hyperactivity
Keywords
Attention Deficit Hyperactivity Disorder, ADHD, School Based, Intervention, Psychosocial, Academic Intervention, Behavioral

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
315 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Challenging Horizons Program after-school model
Arm Type
Experimental
Arm Description
Participants will receive the CHP after-school model.
Arm Title
Challenging Horizons Program consultation model
Arm Type
Experimental
Arm Description
Participants will receive the CHP consultation model.
Arm Title
Community care
Arm Type
No Intervention
Arm Description
Participants will have access to standard community care.
Intervention Type
Behavioral
Intervention Name(s)
Challenging Horizons Program (CHP) after-school model
Intervention Description
Interventions delivered by a counselor 2 days a week as an after-school program. Interventions will strengthen skills in materials organization, homework management, studying, note taking, and socialization.
Intervention Type
Behavioral
Intervention Name(s)
Challenging Horizons Program (CHP) consultation model
Intervention Description
Interventions delivered by a mentor (e.g., a teacher or school counselor) as needed, with expert consultation available
Primary Outcome Measure Information:
Title
Teacher ratings of academic performance on the Impairment Rating Scale
Time Frame
Measured pre-intervention, 3 times during the intervention, post-intervention, and at a 6-month follow-up
Secondary Outcome Measure Information:
Title
Grade point average (GPA)
Time Frame
Measured pre-intervention, post-intervention, and at a 6-month follow-up

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: Meets DSM-IV criteria for ADHD, including all ADHD subtypes (predominately inattentive, predominately hyperactive/impulsive, and combined) All common comorbid conditions not listed as exclusionary will be included. Exclusion Criteria: Full Scale Intelligence Quotient (FSIQ) less than 80 Anticipated attendance for participant or parent less than 80% for scheduled activities Meets diagnostic criteria for bipolar disorder, psychotic disorder, substance dependence (but not substance abuse), or obsessive-compulsive disorder (OCD)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua M. Langberg, PhD
Organizational Affiliation
University of Cincinnati College of Medicine, Cincinnati Children's Hospital Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Steven W. Evans, PhD
Organizational Affiliation
Ohio University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio University
City
Athens
State/Province
Ohio
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center, Center for ADHD
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229-3039
Country
United States

12. IPD Sharing Statement

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Comparing School Based Interventions for Adolescents With Attention Deficit Hyperactivity Disorder

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