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OpenTrials
Completed

NCT Number: NCT00895908

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

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

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Key information

Age range

4 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Friendship Group

Behavioral

Social skills training for 30 sessions, held twice per week over 4 to 5 months

Academic tutoring

Behavioral

Tutoring to support emergent literacy skills, held 1 to 2 times per week over 4 months

Primary outcomes

  1. Attention deficit hyperactivity disorder (ADHD) symptomatology

    Time frame: Measured pre- and post-treatment and at 12-month follow-up

Secondary outcomes

  1. Social competence

    Time frame: Measured pre- and post-treatment and at 12-month follow-up

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Reducing ADHD by Promoting Social Collaboration and Self-Regulation Skills

Important dates

Study start
2009
Primary completion
2012
Study completion
2013
First posted
May 8, 2009
Registry last updated
Mar 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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