Selective Prevention of Anxiety Disorders in Children: A Parent Training Intervention for Anxious Parents

Anxiety Disorders Clinical Trial

Official title:

Selective Prevention of Anxiety Disorders in Children: A Randomized Controlled Preliminary Study of a Parent Training Intervention for Anxious Parents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02386410
• Other study ID #: AGJA-02
• Status: Completed
• Phase: N/A
• First received: March 5, 2015
• Last updated: November 9, 2017
• Start date: August 2015
• Est. completion date: January 2017

Study information

• Verified date: November 2017
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Disease

Intervention

Behavioral:
• Group parent training for anxious parents

• Internet delivered parent training for anxious parents

Locations

Country	Name	City	State
Sweden	Karolinska Institutet	Solna

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety Disorders Interview Schedule - Child and Parent Version		At 12-month follow up
Secondary	The Spence Children's Anxiety Scale	Rated by the child and the parent independently	Change from baseline in anxiety symptom scores at 12 months follow-up
Secondary	Children Depression Inventory	Rated by the child	Change from baseline in depressive symptom scores at 12 months follow-up
Secondary	The Rearing Behavior Questionnaire	Rated by parents	Change from baseline in rearing behavior scores at 12 months follow-up
Secondary	Strengths and Difficulties Questionnaire	Rated by parents	Change from baseline in dfficulties scores at 12 months follow-up
Secondary	State-Trait Anxiety Inventory	Rated by parents	Change from baseline in anxiety symptom scores at 12 months follow-up
Secondary	Montgomery-Åsberg Depression Rating Scale	Rated by parents	Change from baseline in depressive symptom scores at 12 months follow-up
Secondary	Quality of Life Inventory	Rated by parents	Change from baseline in quality of life scores at 12 months follow-up