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

Primary Purpose

Attention Deficit Disorder With Hyperactivity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Friendship Group
Academic tutoring
Sponsored by
Penn State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Attention Deficit Disorder With Hyperactivity focused on measuring ADHD, Psychosocial Intervention, Social Skills Training

Eligibility Criteria

4 Years - 7 Years (Child)All SexesAccepts 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Friendship Group Intervention

    Individual Tutoring

    Arm Description

    Participants will receive the "Friendship Groups" intervention.

    Participants will receive individual academic tutoring.

    Outcomes

    Primary Outcome Measures

    Attention deficit hyperactivity disorder (ADHD) symptomatology

    Secondary Outcome Measures

    Social competence

    Full Information

    First Posted
    May 7, 2009
    Last Updated
    March 7, 2017
    Sponsor
    Penn State University
    Collaborators
    National Institute of Mental Health (NIMH)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00895908
    Brief Title
    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

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    July 1, 2009 (Actual)
    Primary Completion Date
    April 30, 2012 (Actual)
    Study Completion Date
    April 30, 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Penn State University
    Collaborators
    National Institute of Mental Health (NIMH)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Attention Deficit Disorder With Hyperactivity
    Keywords
    ADHD, Psychosocial Intervention, Social Skills Training

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Comparison of social skill training intervention with active attention control group (academic tutoring)
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    171 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Friendship Group Intervention
    Arm Type
    Experimental
    Arm Description
    Participants will receive the "Friendship Groups" intervention.
    Arm Title
    Individual Tutoring
    Arm Type
    Active Comparator
    Arm Description
    Participants will receive individual academic tutoring.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Friendship Group
    Intervention Description
    Social skills training for 30 sessions, held twice per week over 4 to 5 months
    Intervention Type
    Behavioral
    Intervention Name(s)
    Academic tutoring
    Intervention Description
    Tutoring to support emergent literacy skills, held 1 to 2 times per week over 4 months
    Primary Outcome Measure Information:
    Title
    Attention deficit hyperactivity disorder (ADHD) symptomatology
    Time Frame
    Measured pre- and post-treatment and at 12-month follow-up
    Secondary Outcome Measure Information:
    Title
    Social competence
    Time Frame
    Measured pre- and post-treatment and at 12-month follow-up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    4 Years
    Maximum Age & Unit of Time
    7 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Karen L. Bierman, PhD
    Organizational Affiliation
    The Pennsylvannia State University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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