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

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

      • Solna, Sweden, 17177
        • Karolinska Institutet

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
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.
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.
No Intervention: Wait-list
Parents in the wait-list condition will receive the intervention after 12-month follow-up.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Anxiety Disorders Interview Schedule - Child and Parent Version
Time Frame: At 12-month follow up
At 12-month follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Spence Children's Anxiety Scale
Time Frame: Change from baseline in anxiety symptom scores at 12 months follow-up
Rated by the child and the parent independently
Change from baseline in anxiety symptom scores at 12 months follow-up
Children Depression Inventory
Time Frame: Change from baseline in depressive symptom scores at 12 months follow-up
Rated by the child
Change from baseline in depressive symptom scores at 12 months follow-up
The Rearing Behavior Questionnaire
Time Frame: Change from baseline in rearing behavior scores at 12 months follow-up
Rated by parents
Change from baseline in rearing behavior scores at 12 months follow-up
Strengths and Difficulties Questionnaire
Time Frame: Change from baseline in dfficulties scores at 12 months follow-up
Rated by parents
Change from baseline in dfficulties scores at 12 months follow-up
State-Trait Anxiety Inventory
Time Frame: Change from baseline in anxiety symptom scores at 12 months follow-up
Rated by parents
Change from baseline in anxiety symptom scores at 12 months follow-up
Montgomery-Åsberg Depression Rating Scale
Time Frame: Change from baseline in depressive symptom scores at 12 months follow-up
Rated by parents
Change from baseline in depressive symptom scores at 12 months follow-up
Quality of Life Inventory
Time Frame: Change from baseline in quality of life scores at 12 months follow-up
Rated by parents
Change from baseline in quality of life scores at 12 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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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