Clinical trial NCT02386410: Selective Prevention of Anxiety Disorders in Children: A Parent Training Intervention for Anxious Parents
Official title: Selective Prevention of Anxiety Disorders in Children: A Randomized Controlled Preliminary Study of a Parent Training Intervention for Anxious Parents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorders
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2015-03-11
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Anxiety Disorders Interview Schedule - Child and Parent Version
timeFrame: At 12-month follow up
Secondary outcomes:
measure: The Spence Children's Anxiety Scale
timeFrame: Change from baseline in anxiety symptom scores at 12 months follow-up
measure: Children Depression Inventory
timeFrame: Change from baseline in depressive symptom scores at 12 months follow-up
measure: The Rearing Behavior Questionnaire
timeFrame: Change from baseline in rearing behavior scores at 12 months follow-up
measure: Strengths and Difficulties Questionnaire
timeFrame: Change from baseline in dfficulties scores at 12 months follow-up
measure: State-Trait Anxiety Inventory
timeFrame: Change from baseline in anxiety symptom scores at 12 months follow-up
measure: Montgomery-Åsberg Depression Rating Scale
timeFrame: Change from baseline in depressive symptom scores at 12 months follow-up
measure: Quality of Life Inventory
timeFrame: Change from baseline in quality of life scores at 12 months follow-up
Other outcomes:
Locations:
city: Solna
country: Sweden
facility: Karolinska Institutet
Study officials:
affiliation: Karolinska Institutet
name: Ata Ghaderi, PhD
role: PRINCIPAL_INVESTIGATOR
References: