Comparing School Based Interventions for Adolescents With Attention Deficit Hyperactivity Disorder

Multisite Study of School Based Treatment Approaches for ADHD Adolescents

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

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

315

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ohio
      • Athens, Ohio, United States
        • Ohio University
      • Cincinnati, Ohio, United States, 45229-3039
        • Cincinnati Children's Hospital Medical Center, Center for ADHD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 15 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Challenging Horizons Program after-school model
Participants will receive the 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Measured pre-intervention, 3 times during the intervention, post-intervention, and at a 6-month follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
Grade point average (GPA)
Time Frame: Measured pre-intervention, post-intervention, and at a 6-month follow-up
Measured pre-intervention, post-intervention, and at a 6-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (ACTUAL)

December 1, 2013

Study Completion (ACTUAL)

July 1, 2014

Study Registration Dates

First Submitted

July 27, 2009

First Submitted That Met QC Criteria

July 27, 2009

First Posted (ESTIMATE)

July 28, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

December 16, 2016

Last Update Submitted That Met QC Criteria

December 15, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • R01MH082865 (NIH)
  • DSIR 84-CTS (Division of Services and Intervention Research)
  • R01MH067949 (U.S. NIH Grant/Contract)
  • 1R01MH082865-01A2 (NIH)
  • 1R01MH082864-01A2 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Attention Deficit Disorder With Hyperactivity

Clinical Trials on Challenging Horizons Program (CHP) after-school model

Subscribe