Coaching for Confidence: Evaluating an Internet-based Program to Help Parents Help Children With Difficulty With Anxiety
Primary Purpose
Anxiety Disorders
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
cognitive-behavior therapy
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety Disorders focused on measuring child, behavior therapy, cognitive therapy, parent, 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
Sites / Locations
- University of Manitoba, College of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cognitive-behavior therapy
Arm Description
Cognitive-behavior therapy to teach parents the skills to help their children. Participants will have access to the program as often as they wish and have the post assessment at week 12.
Outcomes
Primary Outcome Measures
Spence Children's Anxiety Scale - Parent-rated
Rating scale describing a child's anxiety symptoms - 39 items
Secondary Outcome Measures
Clinical Global Improvement Scale - parent confidence
7 point rating scale indicating parent confidence in helping child with anxiety
Clinical Global Improvement Scale - child anxiety
7 point rating scale indicating degree of improvement or worsening in child anxiety
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02705261
Brief Title
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
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (undefined)
Primary Completion Date
September 30, 2018 (Anticipated)
Study Completion Date
December 31, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manitoba
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders
Keywords
child, behavior therapy, cognitive therapy, parent, anxiety
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
Open label
Allocation
N/A
Enrollment
92 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive-behavior therapy
Arm Type
Experimental
Arm Description
Cognitive-behavior therapy to teach parents the skills to help their children. Participants will have access to the program as often as they wish and have the post assessment at week 12.
Intervention Type
Behavioral
Intervention Name(s)
cognitive-behavior therapy
Intervention Description
Internet based program to support parents in developing strategies to help their children
Primary Outcome Measure Information:
Title
Spence Children's Anxiety Scale - Parent-rated
Description
Rating scale describing a child's anxiety symptoms - 39 items
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Clinical Global Improvement Scale - parent confidence
Description
7 point rating scale indicating parent confidence in helping child with anxiety
Time Frame
12 weeks
Title
Clinical Global Improvement Scale - child anxiety
Description
7 point rating scale indicating degree of improvement or worsening in child anxiety
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John R. Walker, Ph.D.
Organizational Affiliation
University of Manitoba, College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Manitoba, College of Medicine
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E0W3
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Coaching for Confidence: Evaluating an Internet-based Program to Help Parents Help Children With Difficulty With Anxiety
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