Reducing Attention Deficit Hyperactivity Disorder in Kindergarten and Pre-Kindergarten Children
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|ClinicalTrials.gov Identifier: NCT00895908|
Recruitment Status : Completed
First Posted : May 8, 2009
Last Update Posted : March 10, 2017
|Condition or disease||Intervention/treatment||Phase|
|Attention Deficit Disorder With Hyperactivity||Behavioral: Friendship Group Behavioral: Academic tutoring||Not Applicable|
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|
|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)|
|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|
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
- Attention deficit hyperactivity disorder (ADHD) symptomatology [ Time Frame: Measured pre- and post-treatment and at 12-month follow-up ]
- Social competence [ Time Frame: Measured pre- and post-treatment and at 12-month follow-up ]
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 ClinicalTrials.gov identifier (NCT number): NCT00895908
|Principal Investigator:||Karen L. Bierman, PhD||The Pennsylvannia State University|