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.
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
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity
- What is being tested?
- Challenging Horizons Program (CHP) after-school model and Challenging Horizons Program (CHP) consultation model
- Type of treatment
- Lifestyle or therapy programme
- 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
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 group | Role | What they receive |
|---|---|---|
| Challenging Horizons Program after-school model | Experimental | Participants will receive the CHP after-school model. Receives: Behavioral: Challenging Horizons Program (CHP) after-school model |
| Challenging Horizons Program consultation model | Experimental | Participants will receive the CHP consultation model. Receives: Behavioral: Challenging Horizons Program (CHP) consultation model |
| Community care | No intervention | Participants will have access to standard community care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
- First posted28 Jul 2009 (estimated)
- Study startJul 2010
- Primary completionDec 2013
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Joshua M. Langberg, PhD, Principal investigator, University of Cincinnati College of Medicine, Cincinnati Children's Hospital Medical CenterSteven W. Evans, PhD, Principal investigator, Ohio University
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multisite Study of School Based Treatment Approaches for ADHD Adolescents
- ClinicalTrials.gov ID
- NCT00947973
- Acronym / sponsor ID
- R01MH082865
- Keywords
- Attention Deficit Hyperactivity Disorder, ADHD, School Based, Intervention, Psychosocial, Academic Intervention, Behavioral
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 315 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jul 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 28 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Challenging Horizons Program after-school model | Experimental | Behavioral: Challenging Horizons Program (CHP) after-school modelParticipants will receive the CHP after-school model. |
| Challenging Horizons Program consultation model | Experimental | Behavioral: Challenging Horizons Program (CHP) consultation modelParticipants will receive the CHP consultation model. |
| Community care | No intervention | –Participants will have access to standard community care. |
Who may qualify
- Ages
- 11 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Challenging Horizons Program (CHP) after-school modelInterventions 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. | Behavioural | Challenging Horizons Program after-school model |
| Challenging Horizons Program (CHP) consultation modelInterventions delivered by a mentor (e.g., a teacher or school counselor) as needed, with expert consultation available | Behavioural | Challenging Horizons Program consultation model |
Primary outcome
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
1 secondary outcome
Grade point average (GPA)
Time frame: Measured pre-intervention, post-intervention, and at a 6-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joshua M. Langberg, PhD principal investigator
University of Cincinnati College of Medicine, Cincinnati Children's Hospital Medical Center
Steven W. Evans, PhD principal investigator
Ohio University
2 sites in 1 country: see every site and its status.
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.