NCT02705261

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

March 7, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 10, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

July 24, 2018

Status Verified

July 1, 2018

Enrollment Period

2.6 years

First QC Date

March 7, 2016

Last Update Submit

July 20, 2018

Conditions

Keywords

childbehavior therapycognitive therapyparentanxiety

Outcome Measures

Primary Outcomes (1)

  • Spence Children's Anxiety Scale - Parent-rated

    Rating scale describing a child's anxiety symptoms - 39 items

    12 weeks

Secondary Outcomes (2)

  • Clinical Global Improvement Scale - parent confidence

    12 weeks

  • Clinical Global Improvement Scale - child anxiety

    12 weeks

Study Arms (1)

Cognitive-behavior therapy

EXPERIMENTAL

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

Interventions

Internet based program to support parents in developing strategies to help their children

Cognitive-behavior therapy

Eligibility Criteria

Age4 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Manitoba, College of Medicine

Winnipeg, Manitoba, R3E0W3, Canada

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • John R. Walker, Ph.D.

    University of Manitoba, College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Open label
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Dept of Clinical Health Psychology

Study Record Dates

First Submitted

March 7, 2016

First Posted

March 10, 2016

Study Start

March 1, 2016

Primary Completion

September 30, 2018

Study Completion

December 31, 2018

Last Updated

July 24, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations