Clinical trial NCT00895908: Reducing Attention Deficit Hyperactivity Disorder in Kindergarten and Pre-Kindergarten Children
Official title: Reducing ADHD by Promoting Social Collaboration and Self-Regulation Skills
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Disorder With Hyperactivity
Keywords: ADHD
Psychosocial Intervention
Social Skills Training
Lead sponsor: Penn State University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2009-05-08
Enrollment: 171
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparison of social skill training intervention with active attention control group (academic tutoring)
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Attention deficit hyperactivity disorder (ADHD) symptomatology
timeFrame: Measured pre- and post-treatment and at 12-month follow-up
Secondary outcomes:
measure: Social competence
timeFrame: Measured pre- and post-treatment and at 12-month follow-up
Other outcomes:
Locations:
Study officials:
affiliation: The Pennsylvannia State University
name: Karen L. Bierman, PhD
role: PRINCIPAL_INVESTIGATOR
References: