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Preventing Problems in Children's Social Behavior

Primary Purpose

Behavior Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Training in parenting skills and communication
Sponsored by
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Behavior Disorders focused on measuring Behavioral disorders, Parenting skills and communication, Parent-child interactions, At-risk preschooler, Head Start

Eligibility Criteria

3 Years - 6 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Live in Nashville, TN area Enrolled in Head Start Low income family At risk preschoolers evidencing mild to moderate language delays Evidence of patterns of parent-child interaction associated with poor behavioral outcomes Exclusion Criteria: Not specified

Sites / Locations

  • Institute of Language, Social and Cognitive Development

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 4, 2000
Last Updated
February 21, 2007
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00006446
Brief Title
Preventing Problems in Children's Social Behavior
Official Title
John F. Kennedy Center for Mental Retardation at Vanderbilt University: Preventing Problems in Children's Social Behavior
Study Type
Interventional

2. Study Status

Record Verification Date
April 2003
Overall Recruitment Status
Completed
Study Start Date
July 1996 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2001 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

5. Study Description

Brief Summary
Children who are at risk for problems in school may do better if they and their parents are taught how to communicate with each other between age 3 and 6 when the children enter kindergarten. Three groups of 3 year olds who are in Head Start in the Nashville area will be randomized with their parents to either a 3 year program of skill building or to a control (Head Start only). The children will be tested at the end of the 3 year study and 6 months, 1 year and 2 years later.
Detailed Description
Once established, childhood conduct and behavior disorders are robust and have consistently negative effects on the social and academic behavior of children and adolescents. Early intervention to prevent the development of these disorders is an important alternative to intervention after problem behaviors are well established. Two factors, negative patterns of parent-child interaction associated with poor parenting skills and significant communication deficits, are strongly associated with childhood conduct and behavior disorders. This study is an experimental investigation of a multicomponent, longitudinal intervention with families and children to prevent conduct and behavior disorders in children at high risk for these disorders. The goals of this study are to 1) describe the incidence of significant social problems related to conduct disorders among 3-year old children enrolled in Head Start and 2) examine the effectiveness of an intervention on the behavior of children identified with emergent behavior problems or at highest risk for these problems. There are two phases within this study. In the first phase, 750 three-year-olds will be screened for early indicators of behavior problems and communications deficits using reports of child behavior from parents and teachers, direct assessment of children, and assessments of family support and stress that signal risk for conduct disorder to identify children at highest risk. Data from the first phase will provide information regarding the incidence of behavior problems, allow determination of the most reliable indicators of increased risk status and to explore the specific relationship between early communication development and increased risk for behavior problems. The second phase examines the immediate and longer term effects of prevention intervention to improve children's social behavior and communication skills. Three-year-old children (n=180) that are attending community daycares or therapeutic nurseries serving low-income families, and that have mild to moderate language delays and patterns of parent-child interaction associated with poor behavioral outcomes will be recruited. One hundred and eighty children at high risk for development of conduct disorders and related behavioral problems will be randomized to either an intervention group (n=90) or an untreated control group (n=90). Three successive cohorts of children and families will be randomly assigned to treatment or control groups; each cohort will be followed three years until the child enters kindergarten. The primary intervention will include parent training in communicative interactions and behavior management and direct intervention with the child to teach social communication skills in peer interactions. Secondary intervention will include classroom consultation, maintenance of parent training and child intervention as needed, family support and liaison services, and assistance during child transition into kindergarten. Local Head Start collaborators are included in all phases of the trial. The outcomes of the trial will be examined at four points - immediately after the study period is completed, 6 months later, 1 year later, and 2 years later. The last assessment will focus on academic, social, and mental health outcomes at the end of the children's kindergarten year. Positive effects on children's problem behaviors, social skills, and overall development and positive effects on parent-child interaction are expected to be associated with participation in the treatment condition.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Behavior Disorders
Keywords
Behavioral disorders, Parenting skills and communication, Parent-child interactions, At-risk preschooler, Head Start

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Training in parenting skills and communication

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Live in Nashville, TN area Enrolled in Head Start Low income family At risk preschoolers evidencing mild to moderate language delays Evidence of patterns of parent-child interaction associated with poor behavioral outcomes Exclusion Criteria: Not specified
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann Kaiser, Ph. D.
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Language, Social and Cognitive Development
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37240
Country
United States

12. IPD Sharing Statement

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Preventing Problems in Children's Social Behavior

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