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

The Pennsylvania State University (PENNSTATE) logo

The Pennsylvania State University (PENNSTATE)

Status

Completed

Conditions

Attention Deficit Disorder With Hyperactivity

Treatments

Behavioral: Friendship Group
Behavioral: Academic tutoring

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00895908
DDTR B2-MBT
R34MH085889 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This study will determine the effectiveness of an intervention for preventing at-risk kindergarten and pre-kindergarten children from developing attention deficit hyperactivity disorder.

Full 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.

Enrollment

171 patients

Sex

All

Ages

4 to 7 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

171 participants in 2 patient groups

Friendship Group Intervention
Experimental group
Description:
Participants will receive the "Friendship Groups" intervention.
Treatment:
Behavioral: Friendship Group
Individual Tutoring
Active Comparator group
Description:
Participants will receive individual academic tutoring.
Treatment:
Behavioral: Academic tutoring

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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