NCT00947973

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
315

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2010

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 28, 2009

Completed
11 months until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

December 16, 2016

Status Verified

December 1, 2016

Enrollment Period

3.4 years

First QC Date

July 27, 2009

Last Update Submit

December 15, 2016

Conditions

Keywords

Attention Deficit Hyperactivity DisorderADHDSchool BasedInterventionPsychosocialAcademic InterventionBehavioral

Outcome Measures

Primary Outcomes (1)

  • Teacher ratings of academic performance on the Impairment Rating Scale

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

Study Arms (3)

Challenging Horizons Program after-school model

EXPERIMENTAL

Participants will receive the CHP after-school model.

Behavioral: Challenging Horizons Program (CHP) after-school model

Challenging Horizons Program consultation model

EXPERIMENTAL

Participants will receive the CHP consultation model.

Behavioral: Challenging Horizons Program (CHP) consultation model

Community care

NO INTERVENTION

Participants will have access to standard community care.

Interventions

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 after-school model

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

Challenging Horizons Program consultation model

Eligibility Criteria

Age11 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Meets DSM-IV criteria for ADHD, including all ADHD subtypes (predominately inattentive, predominately hyperactive/impulsive, and combined)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ohio University

Athens, Ohio, United States

Location

Cincinnati Children's Hospital Medical Center, Center for ADHD

Cincinnati, Ohio, 45229-3039, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with HyperactivityBehavior

Interventions

somatostatin, cyclic hexapeptide(Phe-Phe-Trp-Lys-Thr-Phe)-

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Joshua M. Langberg, PhD

    University of Cincinnati College of Medicine, Cincinnati Children's Hospital Medical Center

    PRINCIPAL INVESTIGATOR
  • Steven W. Evans, PhD

    Ohio University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2009

First Posted

July 28, 2009

Study Start

July 1, 2010

Primary Completion

December 1, 2013

Study Completion

July 1, 2014

Last Updated

December 16, 2016

Record last verified: 2016-12

Locations