Effects of Parental Behavior on Child Anxiety Regulation

Generalized Anxiety Disorder Clinical Trial

Official title:

Effects of Parental Behavior on Child Anxiety Regulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00593515
• Other study ID #: 1F31MH064999
• Status: Completed
• Phase: Phase 2
• First received: January 3, 2008
• Last updated: January 3, 2008
• Start date: March 2000
• Est. completion date: April 2004

Study information

• Verified date: January 2008
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2004
• Est. primary completion date: April 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 13 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders
• Anxiety, Separation
• Disease
• Generalized Anxiety Disorder
• Mental Disorders
• Separation Anxiety Disorder
• Social Phobia

Intervention

Behavioral:
• Family cognitive behavioral therapy
12-16 weekly sessions of family cognitive behavioral therapy, 60-80 minutes each
• Child-focused cognitive behavioral therapy
12-16 weekly sessions of child-focused cognitive behavioral therapy, 60-80 minutes each

Locations

Country	Name	City	State
United States	UCLA	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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):314-21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety Disorders Interview Schedule--Child and Parent Versions		Posttreatment	No
Secondary	Multidimension Anxiety Scale for Children		Posttreatment	No