Coaching for Confidence: Evaluating an Internet-based Program to Help Parents Help Children With Difficulty With Anxiety

Anxiety Disorders Clinical Trial

Official title:

Coaching for Confidence: Evaluating an Internet-based Program to Help Parents Help Children With Difficulty With Anxiety

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02705261
• Other study ID #: 246529
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 2016
• Est. completion date: December 31, 2018

Study information

• Verified date: July 2018
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 92
• Est. completion date: December 31, 2018
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders

Intervention

Behavioral:
• cognitive-behavior therapy
Internet based program to support parents in developing strategies to help their children

Locations

Country	Name	City	State
Canada	University of Manitoba, College of Medicine	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spence Children's Anxiety Scale - Parent-rated	Rating scale describing a child's anxiety symptoms - 39 items	12 weeks
Secondary	Clinical Global Improvement Scale - parent confidence	7 point rating scale indicating parent confidence in helping child with anxiety	12 weeks
Secondary	Clinical Global Improvement Scale - child anxiety	7 point rating scale indicating degree of improvement or worsening in child anxiety	12 weeks