- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02386410
Selective Prevention of Anxiety Disorders in Children: A Parent Training Intervention for Anxious Parents
November 9, 2017 updated by: Ata Ghaderi, Karolinska Institutet
Selective Prevention of Anxiety Disorders in Children: A Randomized Controlled Preliminary Study of a Parent Training Intervention for Anxious Parents
Anxiety is the most frequent psychiatric problem in children.
Untreated anxiety often has a chronic course, or may be a recurring condition.
Anxiety in children predicts a variety of psychiatric disorders later in life, and involves problems regarding school performance and social relations.
The literature provides a number of factors, which are suggested to increase the risk of developing an anxiety disorder.
In particular, it has been shown that children of parents with anxiety disorders are at much greater risk of developing an anxiety disorder.
Several studies have found a correlation between anxiety in the child, and parent behavior characterized by criticism, control and overprotectiveness.
The present study aim to preliminary evaluate whether a eight week parent training intervention can reduce the incidence of anxiety disorders in children and to evaluate the feasibility of the parent training.
Three central factors has been the basis in developing the parent training, all of which are considered to be involved in the development and maintenance of anxiety disorders in children (1) criticism and rejection, (2) control and overprotectiveness, and (3) parental modeling and reinforcement of anxiety.
The goal of the parent training is therefore (1) to increase warmth and acceptance, (2) to increase autonomy for the child, and (3) modeling and reinforcement of brave behavior.
The investigators intend to include 60 anxious parents in the study, who will be randomly allocated to either group parent training, Internet delivered parent training, or wait-list condition.
The inclusion criteria are as follows: The parent states that he/she experiences anxiety or worry, the parents' child is 6-12 years old, and do not fulfill criteria for an anxiety disorder or major depressive disorder, the parent possesses everyday access to the Internet, and there is no presence of very aggravated family situations, such as parent substance abuse or severe depression, or domestic violence.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Solna, Sweden, 17177
- Karolinska Institutet
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- The parent states that he/she experiences anxiety or worry,
- The parents' child is 6-12 years old, and do not fulfill criteria for an anxiety disorder or major depressive disorder
- The parent possesses everyday access to the Internet
Exclusion Criteria:
- Presence of very aggravated family situations, such as parent substance abuse or severe depression, or domestic violence.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Group parent training
The intervention Group parent training for anxious parents is delivered in groups of about five, in 90 minutes per session, for eight consecutive weeks.
The parent training is delivered by a licensed psychologist.
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Experimental: Internet delivered parent training
In the internet delivered parent training for anxious parents, parents are asked to work with one chapter each week, for eight consecutive weeks.
Each chapter mirrors a session in the group format.
Parents are able to e-mail a licensed psychologist during the intervention.
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No Intervention: Wait-list
Parents in the wait-list condition will receive the intervention after 12-month follow-up.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Anxiety Disorders Interview Schedule - Child and Parent Version
Time Frame: At 12-month follow up
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At 12-month follow up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The Spence Children's Anxiety Scale
Time Frame: Change from baseline in anxiety symptom scores at 12 months follow-up
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Rated by the child and the parent independently
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Change from baseline in anxiety symptom scores at 12 months follow-up
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Children Depression Inventory
Time Frame: Change from baseline in depressive symptom scores at 12 months follow-up
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Rated by the child
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Change from baseline in depressive symptom scores at 12 months follow-up
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The Rearing Behavior Questionnaire
Time Frame: Change from baseline in rearing behavior scores at 12 months follow-up
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Rated by parents
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Change from baseline in rearing behavior scores at 12 months follow-up
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Strengths and Difficulties Questionnaire
Time Frame: Change from baseline in dfficulties scores at 12 months follow-up
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Rated by parents
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Change from baseline in dfficulties scores at 12 months follow-up
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State-Trait Anxiety Inventory
Time Frame: Change from baseline in anxiety symptom scores at 12 months follow-up
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Rated by parents
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Change from baseline in anxiety symptom scores at 12 months follow-up
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Montgomery-Åsberg Depression Rating Scale
Time Frame: Change from baseline in depressive symptom scores at 12 months follow-up
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Rated by parents
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Change from baseline in depressive symptom scores at 12 months follow-up
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Quality of Life Inventory
Time Frame: Change from baseline in quality of life scores at 12 months follow-up
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Rated by parents
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Change from baseline in quality of life scores at 12 months follow-up
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ata Ghaderi, PhD, Karolinska Institutet
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2015
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
January 1, 2017
Study Registration Dates
First Submitted
March 5, 2015
First Submitted That Met QC Criteria
March 5, 2015
First Posted (Estimate)
March 11, 2015
Study Record Updates
Last Update Posted (Actual)
November 13, 2017
Last Update Submitted That Met QC Criteria
November 9, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AGJA-02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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