NCT00895908

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
171

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2009

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 8, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2013

Completed
Last Updated

March 10, 2017

Status Verified

March 1, 2017

Enrollment Period

2.8 years

First QC Date

May 7, 2009

Last Update Submit

March 7, 2017

Conditions

Attention Deficit Disorder With Hyperactivity

Keywords

ADHDPsychosocial InterventionSocial Skills Training

Outcome Measures

Primary Outcomes (1)

  • Attention deficit hyperactivity disorder (ADHD) symptomatology

    Measured pre- and post-treatment and at 12-month follow-up

Secondary Outcomes (1)

  • Social competence

    Measured pre- and post-treatment and at 12-month follow-up

Study Arms (2)

Friendship Group Intervention

EXPERIMENTAL

Participants will receive the "Friendship Groups" intervention.

Behavioral: Friendship Group

Individual Tutoring

ACTIVE COMPARATOR

Participants will receive individual academic tutoring.

Behavioral: Academic tutoring

Interventions

Friendship GroupBEHAVIORAL

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

Friendship Group Intervention
Academic tutoringBEHAVIORAL

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

Individual Tutoring

Eligibility Criteria

Age4 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Clinical or subclinical levels of ADHD symptomatology, based upon teacher and parent report

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Karen L. Bierman, PhD

    The Pennsylvannia State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Comparison of social skill training intervention with active attention control group (academic tutoring)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 7, 2009

First Posted

May 8, 2009

Study Start

July 1, 2009

Primary Completion

April 30, 2012

Study Completion

April 30, 2013

Last Updated

March 10, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share