Clinical Trials Directory

Trials / Completed

CompletedNCT00895908

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

Reducing ADHD by Promoting Social Collaboration and Self-Regulation Skills

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
171 (actual)
Sponsor
Penn State University · Academic / Other
Sex
All
Age
4 Years – 7 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALFriendship GroupSocial skills training for 30 sessions, held twice per week over 4 to 5 months
BEHAVIORALAcademic tutoringTutoring to support emergent literacy skills, held 1 to 2 times per week over 4 months

Timeline

Start date
2009-07-01
Primary completion
2012-04-30
Completion
2013-04-30
First posted
2009-05-08
Last updated
2017-03-10

Source: ClinicalTrials.gov record NCT00895908. Inclusion in this directory is not an endorsement.