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.
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
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.
- Conditions
- Behavior Disorders
- 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.
- First posted6 Nov 2000 (estimated)
- Study startJul 1996
- Study completionJun 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavior DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Institute of Mental Health (NIMH)
- Investigators
- Ann Kaiser, Ph. D., Principal investigator, Vanderbilt University
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- John F. Kennedy Center for Mental Retardation at Vanderbilt University: Preventing Problems in Children's Social Behavior
- ClinicalTrials.gov ID
- NCT00006446
- Acronym / sponsor ID
- NICHD-0500
- Conditions
- Behavior Disorders
- Keywords
- Behavioral disorders, Parenting skills and communication, Parent-child interactions, At-risk preschooler, Head Start
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jul 1996
- Study completion
- Jun 2001
- First posted
- 6 Nov 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Not specified
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training in parenting skills and communication | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann Kaiser, Ph. D. principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
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.