- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00593515
Effects of Parental Behavior on Child Anxiety Regulation
January 3, 2008 updated by: University of California, Los Angeles
Does parenting style affect emotion regulation among children who initially demonstrate high levels of fear and anxiety?
Although recent correlational research has demonstrated a linkage between parental behaviors, such as excessive intrusiveness, and children's manifestations of fear and anxiety, it is not clear if parenting behaviors directly influence children's ability to regulate these emotions.
Alternatively, these parental behaviors may be elicited by children who express fears and anxieties more frequently than other children do.
Experimental research designs would offer a more definitive test of these competing explanations of the extant correlational findings.
Intervention studies, in particular, can test whether experimentally manipulating current family interaction patterns affects children's ability to regulate emotion.
This study provides a preliminary experimental test of the relationship between parental behavior and children's regulation of fear and anxiety.
Some 40 clinically anxious youth, aged 6-13, were randomly assigned to a family intervention program for childhood anxiety problems, which includes extensive parent communication training, or a child intervention program without parent-training.
By comparing these two interventions, we tested if it was possible to improve parenting behaviors-such as intrusiveness-through intensive parent-training, above and beyond the effects of involving children in a child intervention program.
We then tested the impact of this change in parental behaviors on children's ability to regulate fear and anxiety.
We hypothesized that parent-training would reduce intrusiveness, which would in turn improve children's anxiety outcomes.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Los Angeles, California, United States, 90095
- UCLA
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 13 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- The child met DSM-IV criteria for a diagnosis of a principal anxiety disorder based on a semi-structured interview
- The child was not taking any psychiatric medication at the initial assessment, or was taking a stable dose of psychiatric medication (i.e., at least one month at a stable dose prior to the baseline assessment), and
- If medication was being used, families stated an intention to maintain that dose throughout the study.
Exclusion Criteria:
- The child was currently in child-focused psychotherapy
- The family was currently in family therapy or a parenting class
- Either the child or the parents evidenced psychotic symptoms
- The child began taking psychiatric medication or increased his/her dose of medication during the intervention, or
- For any reason the child or parents appeared unable to participate in the intervention program.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Family CBT
|
12-16 weekly sessions of family cognitive behavioral therapy, 60-80 minutes each
|
Active Comparator: 2
Child-focused CBT
|
12-16 weekly sessions of child-focused cognitive behavioral therapy, 60-80 minutes each
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Anxiety Disorders Interview Schedule--Child and Parent Versions
Time Frame: Posttreatment
|
Posttreatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Multidimension Anxiety Scale for Children
Time Frame: Posttreatment
|
Posttreatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Jeffrey Wood, Ph.D., University of California, Los Angeles
- Principal Investigator: Marian Sigman, Ph.D., University of California, Los Angeles
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2000
Primary Completion (Actual)
April 1, 2004
Study Completion (Actual)
April 1, 2004
Study Registration Dates
First Submitted
January 3, 2008
First Submitted That Met QC Criteria
January 3, 2008
First Posted (Estimate)
January 15, 2008
Study Record Updates
Last Update Posted (Estimate)
January 15, 2008
Last Update Submitted That Met QC Criteria
January 3, 2008
Last Verified
January 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1F31MH064999 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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