Clinical trial NCT00593515: Effects of Parental Behavior on Child Anxiety Regulation
Official title: Effects of Parental Behavior on Child Anxiety Regulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Separation Anxiety Disorder
Social Phobia
Generalized Anxiety Disorder
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2008-01-15
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Anxiety Disorders Interview Schedule--Child and Parent Versions
timeFrame: Posttreatment
Secondary outcomes:
measure: Multidimension Anxiety Scale for Children
timeFrame: Posttreatment
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Jeffrey Wood, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Los Angeles
name: Marian Sigman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.