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

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.

Study Overview

• Status: Unknown
• Conditions: Anxiety Disorders
• Intervention / Treatment: Behavioral: cognitive-behavior therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E0W3
      • University of Manitoba, College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive-behavior therapy; 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.	Behavioral: cognitive-behavior therapy; Internet based program to support parents in developing strategies to help their children

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spence Children's Anxiety Scale - Parent-rated	Rating scale describing a child's anxiety symptoms - 39 items	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Global Improvement Scale - parent confidence	7 point rating scale indicating parent confidence in helping child with anxiety	12 weeks
Clinical Global Improvement Scale - child anxiety	7 point rating scale indicating degree of improvement or worsening in child anxiety	12 weeks

Collaborators and Investigators

• Sponsor: University of Manitoba
• Investigators: Principal Investigator: John R. Walker, Ph.D., University of Manitoba, College of Medicine

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Anticipated): September 30, 2018
• Study Completion (Anticipated): December 31, 2018

Study Registration Dates

• First Submitted: March 7, 2016
• First Submitted That Met QC Criteria: March 9, 2016
• First Posted (Estimate): March 10, 2016

Study Record Updates

• Last Update Posted (Actual): July 24, 2018
• Last Update Submitted That Met QC Criteria: July 20, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: anxiety; child; behavior therapy; cognitive therapy; parent
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 246529

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO