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

Attention Deficit Disorder With Hyperactivity Clinical Trial

Official title:

Reducing ADHD by Promoting Social Collaboration and Self-Regulation Skills

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00895908
• Other study ID #: R34MH085889
• Secondary ID: R34MH085889DDTR
• Status: Completed
• Phase: N/A
• First received: May 7, 2009
• Last updated: March 7, 2017
• Start date: July 1, 2009
• Est. completion date: April 30, 2013

Study information

• Verified date: March 2017
• Source: Penn State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 171
• Est. completion date: April 30, 2013
• Est. primary completion date: April 30, 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 7 Years

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit Disorder With Hyperactivity
• Hyperkinesis

Intervention

Behavioral:
• Friendship Group
Social skills training for 30 sessions, held twice per week over 4 to 5 months
• Academic tutoring
Tutoring to support emergent literacy skills, held 1 to 2 times per week over 4 months

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Penn State University	National Institute of Mental Health (NIMH)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Attention deficit hyperactivity disorder (ADHD) symptomatology		Measured pre- and post-treatment and at 12-month follow-up
Secondary	Social competence		Measured pre- and post-treatment and at 12-month follow-up