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Completed

NCT Number: NCT02386410

Selective Prevention of Anxiety Disorders in Children: 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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska Institutet

Solna, 17177, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Group parent training for anxious parents

Behavioral

Internet delivered parent training for anxious parents

Behavioral

Primary outcomes

  1. Anxiety Disorders Interview Schedule - Child and Parent Version

    Time frame: At 12-month follow up

Secondary outcomes

  1. 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

  2. Children Depression Inventory

    Time frame: Change from baseline in depressive symptom scores at 12 months follow-up

    Rated by the child

  3. The Rearing Behavior Questionnaire

    Time frame: Change from baseline in rearing behavior scores at 12 months follow-up

    Rated by parents

  4. Strengths and Difficulties Questionnaire

    Time frame: Change from baseline in dfficulties scores at 12 months follow-up

    Rated by parents

  5. State-Trait Anxiety Inventory

    Time frame: Change from baseline in anxiety symptom scores at 12 months follow-up

    Rated by parents

  6. Montgomery-Åsberg Depression Rating Scale

    Time frame: Change from baseline in depressive symptom scores at 12 months follow-up

    Rated by parents

  7. Quality of Life Inventory

    Time frame: Change from baseline in quality of life scores at 12 months follow-up

    Rated by parents

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Mar 11, 2015
Registry last updated
Nov 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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