Comparing School Based Interventions for Adolescents With Attention Deficit Hyperactivity Disorder

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Children's Hospital Medical Center, Cincinnati.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT00947973
First received: July 27, 2009
Last updated: July 29, 2013
Last verified: February 2012
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multisite Study of School Based Treatment Approaches for ADHD Adolescents

Resource links provided by NLM:


Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Grade point average (GPA) [ Time Frame: Measured pre-intervention, post-intervention, and at a 6-month follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 315
Study Start Date: July 2010
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   11 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00947973

Locations
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
Investigators
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
  More Information

No publications provided

Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT00947973     History of Changes
Other Study ID Numbers: R01 MH082865, R01MH067949, 1 R01 MH082865-01A2, 1 R01 MH082864-01A2, DSIR 84-CTS
Study First Received: July 27, 2009
Last Updated: July 29, 2013
Health Authority: United States: Federal Government

Keywords provided by Children's Hospital Medical Center, Cincinnati:
Attention Deficit Hyperactivity Disorder
ADHD
School Based
Intervention
Psychosocial
Academic Intervention
Behavioral

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Disease
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Pathologic Processes

ClinicalTrials.gov processed this record on September 22, 2014