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Comparing School Based Interventions for Adolescents With Attention Deficit Hyperactivity Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00947973
Recruitment Status : Completed
First Posted : July 28, 2009
Last Update Posted : December 16, 2016
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Brief Summary:
This study will compare the efficacy and cost effectiveness of two methods of treating adolescents with attention deficit hyperactivity disorder in school.

Condition or disease Intervention/treatment Phase
Attention Deficit Disorder With Hyperactivity Behavioral: Challenging Horizons Program (CHP) after-school model Behavioral: Challenging Horizons Program (CHP) consultation model Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 315 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multisite Study of School Based Treatment Approaches for ADHD Adolescents
Study Start Date : July 2010
Actual Primary Completion Date : December 2013
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Challenging Horizons Program after-school model
Participants will receive the CHP after-school model.
Behavioral: Challenging Horizons Program (CHP) after-school model
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.

Experimental: Challenging Horizons Program consultation model
Participants will receive the CHP consultation model.
Behavioral: Challenging Horizons Program (CHP) consultation model
Interventions delivered by a mentor (e.g., a teacher or school counselor) as needed, with expert consultation available

No Intervention: Community care
Participants will have access to standard community care.

Primary Outcome Measures :
  1. 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 Measures :
  1. Grade point average (GPA) [ Time Frame: Measured pre-intervention, post-intervention, and at a 6-month follow-up ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   11 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00947973

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United States, Ohio
Ohio University
Athens, Ohio, United States
Cincinnati Children's Hospital Medical Center, Center for ADHD
Cincinnati, Ohio, United States, 45229-3039
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
National Institute of Mental Health (NIMH)
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Principal Investigator: Joshua M. Langberg, PhD University of Cincinnati College of Medicine, Cincinnati Children's Hospital Medical Center
Principal Investigator: Steven W. Evans, PhD Ohio University
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Responsible Party: Children's Hospital Medical Center, Cincinnati Identifier: NCT00947973    
Other Study ID Numbers: R01MH082865 ( U.S. NIH Grant/Contract )
R01MH067949 ( U.S. NIH Grant/Contract )
1R01MH082865-01A2 ( U.S. NIH Grant/Contract )
1R01MH082864-01A2 ( U.S. NIH Grant/Contract )
First Posted: July 28, 2009    Key Record Dates
Last Update Posted: December 16, 2016
Last Verified: December 2016
Keywords provided by Children's Hospital Medical Center, Cincinnati:
Attention Deficit Hyperactivity Disorder
School Based
Academic Intervention
Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases