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Clinical Trials/NCT00895908
NCT00895908
Completed
N/A

Reducing ADHD by Promoting Social Collaboration and Self-Regulation Skills

Penn State University0 sites171 target enrollmentJuly 1, 2009

Overview

Phase
N/A
Intervention
Not specified
Conditions
Attention Deficit Disorder With Hyperactivity
Sponsor
Penn State University
Enrollment
171
Primary Endpoint
Attention deficit hyperactivity disorder (ADHD) symptomatology
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2009
End Date
April 30, 2013
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Karen Bierman

Professor

Penn State University

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

Outcomes

Primary Outcomes

Attention deficit hyperactivity disorder (ADHD) symptomatology

Time Frame: Measured pre- and post-treatment and at 12-month follow-up

Secondary Outcomes

  • Social competence(Measured pre- and post-treatment and at 12-month follow-up)

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