Reducing Attention Deficit Hyperactivity Disorder in Kindergarten and Pre-Kindergarten Children
Primary Purpose
Attention Deficit Disorder With Hyperactivity
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Friendship Group
Academic tutoring
Sponsored by
About this trial
This is an interventional prevention trial for Attention Deficit Disorder With Hyperactivity focused on measuring ADHD, Psychosocial Intervention, Social Skills Training
Eligibility Criteria
Inclusion Criteria:
- Clinical or subclinical levels of ADHD symptomatology, based upon teacher and parent report
Exclusion Criteria:
- Presence of sensorimotor disability, frank neurological disorder, or psychosis
- Estimated Full Scale Intelligence Quotient (FSIQ) less than 70
- Very low levels of English proficiency that preclude completion of the assessment battery
- In a temporary custody situation with uncertain outcome
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Friendship Group Intervention
Individual Tutoring
Arm Description
Participants will receive the "Friendship Groups" intervention.
Participants will receive individual academic tutoring.
Outcomes
Primary Outcome Measures
Attention deficit hyperactivity disorder (ADHD) symptomatology
Secondary Outcome Measures
Social competence
Full Information
NCT ID
NCT00895908
First Posted
May 7, 2009
Last Updated
March 7, 2017
Sponsor
Penn State University
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00895908
Brief Title
Reducing Attention Deficit Hyperactivity Disorder in Kindergarten and Pre-Kindergarten Children
Official Title
Reducing ADHD by Promoting Social Collaboration and Self-Regulation Skills
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
July 1, 2009 (Actual)
Primary Completion Date
April 30, 2012 (Actual)
Study Completion Date
April 30, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Penn State University
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will determine the effectiveness of an intervention for preventing at-risk kindergarten and pre-kindergarten children from developing attention deficit hyperactivity disorder.
Detailed Description
Attention deficit hyperactivity disorder (ADHD) is characterized by inattention, impulsiveness, and hyperactivity. ADHD is not commonly diagnosed until a child has entered formal schooling and shown academic and behavioral adjustment difficulties, but developmental research suggests that risk factors for developing ADHD are evident earlier. A significant number of children start school with high levels of disorganized and inattentive behaviors, which are symptoms of emerging ADHD. This study will test an intervention aimed at preventing the development of ADHD by identifying those at risk for developing ADHD in kindergarten and pre-kindergarten and teaching them self-regulation skills through socialization. These skills have been associated with school success, and they may reduce the likelihood of children developing ADHD.
Participation in this study will last for 4 months, with a follow-up assessment after 1 year. To enroll, child participants will undergo a screening process that will include assessments by their teachers and parents. Eligible child participants will also be assessed by researchers in a classroom setting. They will then be randomly assigned to receive either a play-based intervention, called the Friendship Group, or an individual pre-academic tutoring intervention. Both groups will meet at school. The Friendship Group, which will focus on strengthening attention and self-regulation through social skills, will involve 30 sessions twice a week for 15 weeks. The tutoring intervention, which will focus on strengthening academic skills, will involve one or two sessions a week for 4 months. Participants will be assessed at three time points: pre-intervention, post-intervention, and after 1 year. Assessments will include teacher ratings and direct testing of child attention, language, and pre-academic skills.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Disorder With Hyperactivity
Keywords
ADHD, Psychosocial Intervention, Social Skills Training
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Comparison of social skill training intervention with active attention control group (academic tutoring)
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
171 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Friendship Group Intervention
Arm Type
Experimental
Arm Description
Participants will receive the "Friendship Groups" intervention.
Arm Title
Individual Tutoring
Arm Type
Active Comparator
Arm Description
Participants will receive individual academic tutoring.
Intervention Type
Behavioral
Intervention Name(s)
Friendship Group
Intervention Description
Social skills training for 30 sessions, held twice per week over 4 to 5 months
Intervention Type
Behavioral
Intervention Name(s)
Academic tutoring
Intervention Description
Tutoring to support emergent literacy skills, held 1 to 2 times per week over 4 months
Primary Outcome Measure Information:
Title
Attention deficit hyperactivity disorder (ADHD) symptomatology
Time Frame
Measured pre- and post-treatment and at 12-month follow-up
Secondary Outcome Measure Information:
Title
Social competence
Time Frame
Measured pre- and post-treatment and at 12-month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Clinical or subclinical levels of ADHD symptomatology, based upon teacher and parent report
Exclusion Criteria:
Presence of sensorimotor disability, frank neurological disorder, or psychosis
Estimated Full Scale Intelligence Quotient (FSIQ) less than 70
Very low levels of English proficiency that preclude completion of the assessment battery
In a temporary custody situation with uncertain outcome
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen L. Bierman, PhD
Organizational Affiliation
The Pennsylvannia State University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Reducing Attention Deficit Hyperactivity Disorder in Kindergarten and Pre-Kindergarten Children
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