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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by National Institute of Mental Health (NIMH).
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00895908
First received: May 7, 2009
Last updated: June 25, 2009
Last verified: June 2009
  Purpose

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 Intervention Phase
Attention Deficit Disorder With Hyperactivity
Behavioral: Friendship Group
Behavioral: Academic tutoring
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Reducing ADHD by Promoting Social Collaboration and Self-Regulation Skills

Resource links provided by NLM:


Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Attention deficit hyperactivity disorder (ADHD) symptomatology [ Time Frame: Measured pre- and post-treatment and at 12-month follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Social competence [ Time Frame: Measured pre- and post-treatment and at 12-month follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 178
Study Start Date: January 2010
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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: 2
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

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.

  Eligibility

Ages Eligible for Study:   4 Years to 7 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00895908

Contacts
Contact: Karen L. Bierman, PhD 814-865-3879 kb2@psu.edu

Sponsors and Collaborators
Investigators
Principal Investigator: Karen L. Bierman, PhD The Pennsylvannia State University
  More Information

No publications provided

Responsible Party: Karen L. Bierman, PhD, Professor of Psychology, The Pennsylvania State University
ClinicalTrials.gov Identifier: NCT00895908     History of Changes
Other Study ID Numbers: R34 MH085889, DDTR B2-MBT
Study First Received: May 7, 2009
Last Updated: June 25, 2009
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
ADHD
Psychosocial Intervention
Social Skills Training

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 25, 2014