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Attention Deficit Disorder With HyperactivityPhase 2NCT00947973

Comparing School Based Interventions for Adolescents With Attention Deficit Hyperactivity Disorder

A Phase 2 study testing Challenging Horizons Program (CHP) after-school model and Challenging Horizons Program (CHP) consultation model in people with Attention Deficit Disorder With Hyperactivity, run by Children's Hospital Medical Center, Cincinnati at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 11 to 15 years
What is being tested?
Challenging Horizons Program (CHP) after-school model and Challenging Horizons Program (CHP) consultation model
Could I receive a placebo?
No, everyone receives an active treatment
How many people
315 participants
Where
2 sitesUnited States
Study dates
Jul 2010to Jul 2014
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 11 to 15 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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)

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Ohio University

    Athens, Ohio

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

    Cincinnati, Ohio, 45229-3039

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Challenging Horizons Program (CHP) after-school model, Challenging Horizons Program (CHP) consultation model
Keywords
Attention Deficit Hyperactivity Disorder, ADHD, School Based, Intervention, Psychosocial, Academic Intervention, Behavioral
Medical subject headings
Attention Deficit Disorder with Hyperactivity, Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Challenging Horizons Program (CHP) after-school modelBehavioural

    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.

  • Challenging Horizons Program (CHP) consultation modelBehavioural

    Interventions delivered by a mentor (e.g., a teacher or school counselor) as needed, with expert consultation available

Study groups in NCT00947973
Study groupRoleWhat they receive
Challenging Horizons Program after-school modelExperimentalParticipants will receive the CHP after-school model.
Receives: Behavioral: Challenging Horizons Program (CHP) after-school model
Challenging Horizons Program consultation modelExperimentalParticipants will receive the CHP consultation model.
Receives: Behavioral: Challenging Horizons Program (CHP) consultation model
Community careNo interventionParticipants will have access to standard community care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Teacher ratings of academic performance on the Impairment Rating Scale

    Measured: Measured pre-intervention, 3 times during the intervention, post-intervention, and at a 6-month follow-up

Secondary outcomes (1)
  1. Grade point average (GPA)

    Measured: Measured pre-intervention, post-intervention, and at a 6-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2009 (estimated)
  2. Study startJul 2010
  3. Primary completionDec 2013
  4. Study completionJul 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
315 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00947973
Sponsor's protocol ID
R01MH082865
Other IDs
R01MH067949, 1R01MH082865-01A2, 1R01MH082864-01A2, DSIR 84-CTS
Status last verified
Dec 2016
First submitted
27 Jul 2009
Last updated
16 Dec 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Challenging Horizons Program (CHP) after-school model and Challenging Horizons Program (CHP) consultation model in people with Attention Deficit Disorder With Hyperactivity, run by Children's Hospital Medical Center, Cincinnati at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2016.

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