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

Reducing ADHD by Promoting Social Collaboration and Self-Regulation Skills

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

Study Overview

• Status: Completed
• Conditions: Attention Deficit Disorder With Hyperactivity
• Intervention / Treatment: Behavioral: Friendship Group; Behavioral: Academic tutoring

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.

• Study Type: Interventional
• Enrollment (Actual): 171
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 7 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Attention deficit hyperactivity disorder (ADHD) symptomatology	Measured pre- and post-treatment and at 12-month follow-up

Secondary Outcome Measures

Outcome Measure	Time Frame
Social competence	Measured pre- and post-treatment and at 12-month follow-up

Collaborators and Investigators

• Sponsor: Penn State University
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Karen L. Bierman, PhD, The Pennsylvannia State University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2009
• Primary Completion (Actual): April 30, 2012
• Study Completion (Actual): April 30, 2013

Study Registration Dates

• First Submitted: May 7, 2009
• First Submitted That Met QC Criteria: May 7, 2009
• First Posted (Estimate): May 8, 2009

Study Record Updates

• Last Update Posted (Actual): March 10, 2017
• Last Update Submitted That Met QC Criteria: March 7, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: ADHD; Psychosocial Intervention; Social Skills Training
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Hyperkinesis
• Other Study ID Numbers: R34MH085889 (U.S. NIH Grant/Contract); DDTR B2-MBT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No