Reducing Attention Deficit Hyperactivity Disorder in Kindergarten and Pre-Kindergarten Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00895908
Recruitment Status : Completed
First Posted : May 8, 2009
Last Update Posted : March 10, 2017
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Karen Bierman, Penn State University

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.

Condition or disease Intervention/treatment Phase
Attention Deficit Disorder With Hyperactivity Behavioral: Friendship Group Behavioral: Academic tutoring Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 171 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Comparison of social skill training intervention with active attention control group (academic tutoring)
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Reducing ADHD by Promoting Social Collaboration and Self-Regulation Skills
Actual Study Start Date : July 1, 2009
Actual Primary Completion Date : April 30, 2012
Actual Study Completion Date : April 30, 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Friendship Group Intervention
Participants will receive the "Friendship Groups" intervention.
Behavioral: Friendship Group
Social skills training for 30 sessions, held twice per week over 4 to 5 months

Active Comparator: Individual Tutoring
Participants will receive individual academic tutoring.
Behavioral: Academic tutoring
Tutoring to support emergent literacy skills, held 1 to 2 times per week over 4 months

Primary Outcome Measures :
  1. Attention deficit hyperactivity disorder (ADHD) symptomatology [ Time Frame: Measured pre- and post-treatment and at 12-month follow-up ]

Secondary Outcome Measures :
  1. Social competence [ Time Frame: Measured pre- and post-treatment and at 12-month follow-up ]

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00895908

Sponsors and Collaborators
Penn State University
National Institute of Mental Health (NIMH)
Principal Investigator: Karen L. Bierman, PhD The Pennsylvannia State University

Responsible Party: Karen Bierman, Professor, Penn State University Identifier: NCT00895908     History of Changes
Other Study ID Numbers: R34MH085889 ( U.S. NIH Grant/Contract )
R34MH085889 ( U.S. NIH Grant/Contract )
First Posted: May 8, 2009    Key Record Dates
Last Update Posted: March 10, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Karen Bierman, Penn State University:
Psychosocial Intervention
Social Skills Training

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms