Treatment of child anxiety disorder in the context of maternal anxiety

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 210

Inclusion Criteria

Current inclusion criteria as of 21/03/2012
Child:
1. Aged 7 to 12 years
2. Primary diagnosis of DSM-IV generalised anxiety disorder, social phobia, separation anxiety disorder , panic disorder/agoraphobia or specific phobia, co-morbid with one of the previous disorders
3. Absence of significant physical or intellectual impairment (including autistic spectrum disorders)

Mother:
1. Primary carer
2. Current maternal DSM-IV anxiety disorder
3. Absence of severe comorbid disorder (e.g. severe major depressive disorder, psychosis, substance/alcohol dependence)

For both the mother and child:
Absence of psychotropic medication (or, if psychotropic medication is prescribed, it should have been at a stable dose for at least one month with agreement to maintain that dose throughout the study)

Previous inclusion criteria
Child:
1. Aged 7 to 12 years
2. Primary diagnosis of Diagnostic and Statistical Manual of Mental Disorders - fourth edition (DSM-IV) generalised anxiety disorder, social phobia, or separation anxiety disorder
3. Absence of significant physical or intellectual impairment (including autistic spectrum disorders)

Mother:
1. Primary carer
2. Current maternal DSM-IV anxiety disorder
3. Absence of severe comorbid disorder (e.g. severe major depressive disorder, psychosis, substance/alcohol dependence)

For both the mother and child:
Absence of psychotropic medication (or, if psychotropic medication is prescribed, it should have been at a stable dose for at least one month with agreement to maintain that dose throughout the study)

Exclusion Criteria

Child:
1. Aged less than 7 or over 12 years
2. No primary diagnosis of DSM-IV generalised anxiety disorder, social phobia, or separation anxiety disorder
3. Presence of significant physical or intellectual impairment (including autistic spectrum disorders)

Mother:
1. Is not primary carer
2. Absence of current maternal DSM-IV anxiety disorder
3. Presence of severe comorbid disorder (e.g. severe major depressive disorder, psychosis, substance/alcohol dependence)

For both the mother and child:
Presence of psychotropic medication at a stable dose for less than one month

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is child anxiety (assessed both categorically [i.e. diagnosis] and continuously <br>[i.e. symptoms]). Diagnostic status will be assessed by the Anxiety Disorders Interview Schedule (ADIS) for DSM-IV: C/P administered to both the mother and child. Assessors will be blind to treatment condition. Assessors' beliefs about treatment condition will be formally assessed. Child anxiety symptoms will be assessed using questionnaires (Spence Children's Anxiety Scale [SCAS]) administered to the child, the mother and the child's teacher. These measures will be administered post-treatment, and at 6 and 12 month follow-up assessments.

Secondary Outcome Measures

Name	Time	Method
1. Maternal anxiety, assessed categorically using the ADIS (DSM-IV) post-treatment, and at 6- and 12-month follow-up assessments<br>2. Maternal anxiety, assessed continuously using the following questionnaires post-treatment, and at 6- and 12-month follow-up assessments: <br>2.1. Depression Anxiety and Stress Scales (DASS)<br>2.2. Penn State Worry Questionnaire (PSWQ)<br>2.3. Social Interaction Anxiety Scale (SIAS)<br>2.4. Social Phobia Scale (SPS)<br>3. Maternal interactive behaviours will be assessed by filming the mother assisting the child perform an anxiety provoking task and applying standardised ratings of anxiogenic behaviours (i.e. modelling, lack of encouragement, overcontrol/overprotection). Interactive behaviours will be coded by independent, trained, reliable raters. Coders will be blind to the purpose and conditions of the trial. Maternal cognitions will be assessed by a standardised interview. These measures will be conducted at the post-treatment assessment.