AzTrials
AzTrials

Behavior DisordersNCT00006446

Preventing Problems in Children's Social Behavior

A study testing Training in parenting skills and communication in people with Behavior Disorders, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 3 to 6 years
Conditions the study is for
Behavior Disorders
What is being tested?
Training in parenting skills and communication
Type of treatment
Surgery or procedure
How many people
180 participants
Where
1 siteUnited States
Study dates
Jul 1996to Jun 2001
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 6 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • Not specified

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Institute of Language, Social and Cognitive Development

    Nashville, Tennessee, 37240

Other trials in United States

About this study

Official title: John F. Kennedy Center for Mental Retardation at Vanderbilt University: Preventing Problems in Children's Social Behavior

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.

Read the 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.

Being tested
Training in parenting skills and communication
Keywords
Behavioral disorders, Parenting skills and communication, Parent-child interactions, At-risk preschooler, Head Start
Medical subject headings
Mental Disorders, Communication

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Training in parenting skills and communicationProcedure or surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2000 (estimated)
  2. Study startJul 1996
  3. Study completionJun 2001

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
180 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00006446
Sponsor's protocol ID
NICHD-0500
Other IDs
2P30HD015052, NIMH R01MH54629
Status last verified
Apr 2003
First submitted
4 Nov 2000
Last updated
22 Feb 2007
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing Training in parenting skills and communication in people with Behavior Disorders, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Feb 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2007.

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