Attention Deficit and Disruptive Behavior DisordersNCT00001233
Study of Children at Risk for Disruptive Behavior Disorders
An observational study of Attention Deficit and Disruptive Behavior Disorders and Child Behavior Disorders, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial summary
A conduct disorder is characterized by repetitive and persistent patterns of behavior where the basic rights of others and rules are violated. This study investigates characteristics of children and their surroundings (environments) that place them at risk for the development of disruptive behavior disorders and… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit and Disruptive Behavior Disorders, Child Behavior Disorders, Passive-Aggressive Personality Disorder
- How many people
- 900 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 1988to Dec 2000
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Preschool age children with conduct problems and normal preschool age children used for control.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Mental Health (NIMH)
Bethesda, Maryland, 20892
About this study
Official title: A Longitudinal Study of Children at Risk for Disruptive Behavior Disorders: Transitions From Early Childhood to Middle Childhood and Adolescence
A conduct disorder is characterized by repetitive and persistent patterns of behavior where the basic rights of others and rules are violated.
This study investigates characteristics of children and their surroundings (environments) that place them at risk for the development of disruptive behavior disorders and associated disorders of anxiety and mood. Children ages 4 - 5 with moderate (subclinical) and severe (clinical) rates of misconduct during the preschool period are compared to low risk children. Children and their families were recruited from 1989-1991 and are being studied at five specific times:
Read more
- Preschool (4 - 5 years)
- Early childhood (6 - 7 years)
- Middle childhood (9 - 10 years)
- Early adolescence (13 - 14 years)
- Mid-adolescence (15 - 16 years)
Researchers will look closely at biological, intellectual, emotional, and behavioral factors that are thought to protect against and/or increase the risk of developing a conduct problem. These factors have been studied in older children and are shown to be associated with disruptive behavior disorders.
The goals of this research study are;
- Create a database showing the characteristics of the development of disruptive behavior problems.
- Identify the key risk and protective factors that contribute to the stability or change in behavior problems over time.
- Identify the ways that children interact socially and relate them to the possibility of developing a problem of behavior.
- Identify how experiences and the emotions associated with experiences may play a role in the development of related psychiatric conditions, like depression and anxiety.
- Establish measures of the different components of negative emotions associated with disruptive/antisocial, anxiety, and mood disorders.
Read the detailed description
This study investigates characteristics of children and their environments that place them at risk for the development of disruptive behavior disorders and co-morbid internalizing problems (anxiety and mood disorders). Children ages 4-5 with moderate (subclinical) and high (clinical) rates of misconduct during the preschool period are compared with low risk children. Children and their families are studied again at four later time points: (a) early childhood (6-7 yrs.), (b) middle childhood (9-10 yrs.), (c) early adolescence (13-14 yrs.), and (d) mid-adolescence (15-16 yrs.). Assessments of children include dimensions of biological, cognitive, affective, emotional and behavioral functioning, that have been identified in research with older children as putative risk and protective factors in the development of conduct problems. Socialization experiences within and outside the family, also hypothesized to influence developmental trajectories are examined. Currently, Time 4 assessments are being conducted, with three-quarters of the research subjects tested. Behavior problems show significant stability across the first three time periods. However, some children improve over time, changes that result, in part, from more optimal environmental conditions. Different patterns of emotion dysregulation, ANS, and HPA activity in antisocial preschool children predict different types of externalizing problems at later time points. Behavior problems and their correlates differ for young disruptive boys and girls: Oppositional, aggressive girls are more likely to have co-morbid internalizing problems, and emotion regulation patterns that may decrease risk for continued antisocial behavior, but increase risk for depression and anxiety later in development.
- Conditions
- Attention Deficit and Disruptive Behavior Disorders, Child Behavior Disorders, Passive-Aggressive Personality Disorder
- Keywords
- Adolescence, Aggressivity, Anger, Developmental Psychopathology, Disruptive Behavior Disorders, Early Onset Aggression, Emotion Regulation, Family Violence, Preschool Conduct Problems
- Medical subject headings
- Attention Deficit and Disruptive Behavior Disorders, Child Behavior Disorders, Passive-Aggressive Personality Disorder, Emotional Regulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2002 (estimated)
- Study startDec 1988
- Study completionDec 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit and Disruptive Behavior DisordersStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The sponsor's other registered studies.
- 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
- Observational
- Enrolment
- 900 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001233
- Sponsor's protocol ID
- 880217
- Other IDs
- 88-M-0217
- Status last verified
- Jan 2000
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Achenbach TM, Edelbrock CS. Behavioral problems and competencies reported by parents of normal and disturbed children aged four through sixteen. Monogr Soc Res Child Dev. 1981;46(1):1-82.
PubMed 7242540Achenbach TM, Edelbrock CS. The classification of child psychopathology: a review and analysis of empirical efforts. Psychol Bull. 1978 Nov;85(6):1275-1301. No abstract available.
PubMed 366649Cole PM, Zahn-Waxler C, Fox NA, Usher BA, Welsh JD. Individual differences in emotion regulation and behavior problems in preschool children. J Abnorm Psychol. 1996 Nov;105(4):518-29.
PubMed 8952185
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal Study of Children at Risk for Disruptive Behavior Disorders: Transitions From Early Childhood to Middle Childhood and Adolescence
- ClinicalTrials.gov ID
- NCT00001233
- Acronym / sponsor ID
- 880217
- Conditions
- Attention Deficit and Disruptive Behavior Disorders, Child Behavior Disorders, Passive-Aggressive Personality Disorder
- Keywords
- Adolescence, Aggressivity, Anger, Developmental Psychopathology, Disruptive Behavior Disorders, Early Onset Aggression, Emotion Regulation, Family Violence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 900 participants
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- Dec 1988
- Study completion
- Dec 2000
- First posted
- 10 Dec 2002 (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.
A conduct disorder is characterized by repetitive and persistent patterns of behavior where the basic rights of others and rules are violated.
This study investigates characteristics of children and their surroundings (environments) that place them at risk for the development of disruptive behavior disorders and associated disorders of anxiety and mood. Children ages 4 - 5 with moderate (subclinical) and severe (clinical) rates of misconduct during the preschool period are compared to low risk children. Children and their families were recruited from 1989-1991 and are being studied at five specific times:
- Preschool (4 - 5 years)
- Early childhood (6 - 7 years)
- Middle childhood (9 - 10 years)
- Early adolescence (13 - 14 years)
- Mid-adolescence (15 - 16 years)
Researchers will look closely at biological, intellectual, emotional, and behavioral factors that are thought to protect against and/or increase the risk of developing a conduct problem. These factors have been studied in older children and are shown to be associated with disruptive behavior disorders.
The goals of this research study are;
- Create a database showing the characteristics of the development of disruptive behavior problems.
- Identify the key risk and protective factors that contribute to the stability or change in behavior problems over time.
- Identify the ways that children interact socially and relate them to the possibility of developing a problem of behavior.
- Identify how experiences and the emotions associated with experiences may play a role in the development of related psychiatric conditions, like depression and anxiety.
- Establish measures of the different components of negative emotions associated with disruptive/antisocial, anxiety, and mood disorders.
Detailed description
This study investigates characteristics of children and their environments that place them at risk for the development of disruptive behavior disorders and co-morbid internalizing problems (anxiety and mood disorders). Children ages 4-5 with moderate (subclinical) and high (clinical) rates of misconduct during the preschool period are compared with low risk children. Children and their families are studied again at four later time points: (a) early childhood (6-7 yrs.), (b) middle childhood (9-10 yrs.), (c) early adolescence (13-14 yrs.), and (d) mid-adolescence (15-16 yrs.). Assessments of children include dimensions of biological, cognitive, affective, emotional and behavioral functioning, that have been identified in research with older children as putative risk and protective factors in the development of conduct problems. Socialization experiences within and outside the family, also hypothesized to influence developmental trajectories are examined. Currently, Time 4 assessments are being conducted, with three-quarters of the research subjects tested. Behavior problems show significant stability across the first three time periods. However, some children improve over time, changes that result, in part, from more optimal environmental conditions. Different patterns of emotion dysregulation, ANS, and HPA activity in antisocial preschool children predict different types of externalizing problems at later time points. Behavior problems and their correlates differ for young disruptive boys and girls: Oppositional, aggressive girls are more likely to have co-morbid internalizing problems, and emotion regulation patterns that may decrease risk for continued antisocial behavior, but increase risk for depression and anxiety later in development.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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 4 Mar 2008.
- Background: PubMed 7242540Achenbach TM, Edelbrock CS. Behavioral problems and competencies reported by parents of normal and disturbed children aged four through sixteen. Monogr Soc Res Child Dev. 1981;46(1):1-82.
- Background: PubMed 366649Achenbach TM, Edelbrock CS. The classification of child psychopathology: a review and analysis of empirical efforts. Psychol Bull. 1978 Nov;85(6):1275-1301. No abstract available.
- Background: PubMed 8952185Cole PM, Zahn-Waxler C, Fox NA, Usher BA, Welsh JD. Individual differences in emotion regulation and behavior problems in preschool children. J Abnorm Psychol. 1996 Nov;105(4):518-29.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Attention Deficit and Disruptive Behavior Disorders and Child Behavior Disorders, run by National Institute of Mental Health (NIMH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. 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?
On the ClinicalTrials.gov record for NCT00001233, which also lists 3 linked publications.
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 4 Mar 2008.