Clinical trial NCT02705261: Coaching for Confidence: Evaluating an Internet-based Program to Help Parents Help Children With Difficulty With Anxiety
Official title: Coaching for Confidence: Evaluating an Internet-based Program to Help Parents Help Children With Difficulty With Anxiety
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety Disorders
Keywords: child
behavior therapy
cognitive therapy
parent
anxiety
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2016-03-10
Enrollment: 92
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study is an open trial to evaluate a web-based intervention. The intervention focuses on supporting parents to help their children to overcome problems with anxiety. The children who are the focus of the study are in the age ranges of 4 - 12 and experience problems with separation anxiety, social anxiety, or generalized anxiety as identified by their parents. The program will exclude obsessive-compulsive disorder and post-traumatic stress disorder that are seen less often in this age group and require somewhat different interventions.

Detailed description: Parents will be recruited for the study through stories in the media and notices sent through the schools to parents of school age children. The information will invite parents to contact the study staff if in their view their child is more anxious, fearful, shy or worried than most children of their age. Parents will be screened to insure that the child's problem is appropriate for the study. If the child and family are judged to be appropriate for the study they will be provided a user name and password to access a web-based program called Coaching for Confidence. In the first part of the program they review the consent form and decide if they wish to provide consent. If they provide consent they complete initial assessment measures describing their child and themselves. Once the assessment is completed they have access to the program through the internet. They are encouraged to complete the program over a period of 10 weeks. The program focuses on supporting the parent's understanding of child anxiety and the strategies they can take in helping their child to overcome limitations related to anxiety.

Eligibility criteria: Inclusion Criteria:

* diagnosis of social anxiety, separation anxiety, or generalized anxiety disorder
* judged by parent to have anxiety that interferes with functioning in the home or school.
* judged by clinician to have anxiety that interferes with functioning in the home or school.
* parent unable to read and write in English.
* parent unable to access the internet regularly - at least once a week

Exclusion Criteria:

* diagnosis of obsessive compulsive disorder
* diagnosis of post-traumatic stress disorder
* diagnosis of school refusal and not attending school at least half of the time
* diagnosis of selective mutism
* diagnosis of autism spectrum disorder
* diagnosis of pervasive developmental disorder
* child currently receiving psychosocial treatment for anxiety

Primary outcomes:
measure: Spence Children's Anxiety Scale - Parent-rated
timeFrame: 12 weeks
Secondary outcomes:
measure: Clinical Global Improvement Scale - parent confidence
timeFrame: 12 weeks
measure: Clinical Global Improvement Scale - child anxiety
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: University of Manitoba, College of Medicine
state: Manitoba
Study officials:
affiliation: University of Manitoba, College of Medicine
name: John R. Walker, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: