Anxiety DisordersNCT02705261
Coaching for Confidence: Evaluating an Internet-based Program to Help Parents Help Children With Difficulty With Anxiety
A study testing cognitive-behavior therapy in people with Anxiety Disorders, run by University of Manitoba at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Anxiety Disorders
- What is being tested?
- cognitive-behavior therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2016to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Manitoba, College of Medicine
Winnipeg, Manitoba, R3E0W3
About this study
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.
Read the 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.
- Conditions
- Anxiety Disorders
- Being tested
- cognitive-behavior therapy
- Keywords
- child, behavior therapy, cognitive therapy, parent, anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive-behavior therapyBehavioural
Internet based program to support parents in developing strategies to help their children
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: cognitive-behavior therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spence Children's Anxiety Scale - Parent-rated
Rating scale describing a child's anxiety symptoms - 39 items
Measured: 12 weeks
Secondary outcomes (2)
Clinical Global Improvement Scale - parent confidence
7 point rating scale indicating parent confidence in helping child with anxiety
Measured: 12 weeks
Clinical Global Improvement Scale - child anxiety
7 point rating scale indicating degree of improvement or worsening in child anxiety
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2016 (estimated)
- Study startMar 2016
- Primary completion30 Sep 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. John Walker, University of Manitoba
- Investigators
- John R. Walker, Ph.D., Principal investigator, University of Manitoba, College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02705261
- Sponsor's protocol ID
- 246529
- Status last verified
- Jul 2018
- First submitted
- 7 Mar 2016
- Last updated
- 24 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coaching for Confidence: Evaluating an Internet-based Program to Help Parents Help Children With Difficulty With Anxiety
- ClinicalTrials.gov ID
- NCT02705261
- Acronym / sponsor ID
- 246529
- Conditions
- Anxiety Disorders
- Keywords
- child, behavior therapy, cognitive therapy, parent, anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- 30 Sep 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 10 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cognitive-behavior therapy | Experimental | Behavioral: cognitive-behavior therapyCognitive-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. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cognitive-behavior therapyInternet based program to support parents in developing strategies to help their children | Behavioural | Cognitive-behavior therapy |
Primary outcome
Spence Children's Anxiety Scale - Parent-rated
Time frame: 12 weeks
Rating scale describing a child's anxiety symptoms - 39 items
2 secondary outcomes
Clinical Global Improvement Scale - parent confidence
Time frame: 12 weeks
Clinical Global Improvement Scale - child anxiety
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John R. Walker, Ph.D. principal investigator
University of Manitoba, College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive-behavior therapy in people with Anxiety Disorders, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spence Children's Anxiety Scale - Parent-rated (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2018.