Effects of Parental Behavior on Child Anxiety Regulation
Primary Purpose
Separation Anxiety Disorder, Social Phobia, Generalized Anxiety Disorder
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Family cognitive behavioral therapy
Child-focused cognitive behavioral therapy
Sponsored by
About this trial
This is an interventional treatment trial for Separation Anxiety Disorder
Eligibility Criteria
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.
Sites / Locations
- UCLA
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Family CBT
Child-focused CBT
Outcomes
Primary Outcome Measures
Anxiety Disorders Interview Schedule--Child and Parent Versions
Secondary Outcome Measures
Multidimension Anxiety Scale for Children
Full Information
NCT ID
NCT00593515
First Posted
January 3, 2008
Last Updated
January 3, 2008
Sponsor
University of California, Los Angeles
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00593515
Brief Title
Effects of Parental Behavior on Child Anxiety Regulation
Official Title
Effects of Parental Behavior on Child Anxiety Regulation
Study Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
March 2000 (undefined)
Primary Completion Date
April 2004 (Actual)
Study Completion Date
April 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of California, Los Angeles
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Separation Anxiety Disorder, Social Phobia, Generalized Anxiety Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Family CBT
Arm Title
2
Arm Type
Active Comparator
Arm Description
Child-focused CBT
Intervention Type
Behavioral
Intervention Name(s)
Family cognitive behavioral therapy
Intervention Description
12-16 weekly sessions of family cognitive behavioral therapy, 60-80 minutes each
Intervention Type
Behavioral
Intervention Name(s)
Child-focused cognitive behavioral therapy
Intervention Description
12-16 weekly sessions of child-focused cognitive behavioral therapy, 60-80 minutes each
Primary Outcome Measure Information:
Title
Anxiety Disorders Interview Schedule--Child and Parent Versions
Time Frame
Posttreatment
Secondary Outcome Measure Information:
Title
Multidimension Anxiety Scale for Children
Time Frame
Posttreatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Wood, Ph.D.
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marian Sigman, Ph.D.
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
16540816
Citation
Wood JJ, Piacentini JC, Southam-Gerow M, Chu BC, Sigman M. Family cognitive behavioral therapy for child anxiety disorders. J Am Acad Child Adolesc Psychiatry. 2006 Mar;45(3):314-321. doi: 10.1097/01.chi.0000196425.88341.b0.
Results Reference
result
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Effects of Parental Behavior on Child Anxiety Regulation
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