Overview

This trial is active, not recruiting.

Condition anxiety disorders
Treatments group parent training for anxious parents, internet delivered parent training for anxious parents
Phase phase 1
Sponsor Karolinska Institutet
Start date August 2015
End date December 2016
Trial size 60 participants
Trial identifier NCT02386410, AGJA-02

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
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.
group parent training for anxious parents
(Experimental)
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.
internet delivered parent training for anxious parents
(No Intervention)
Parents in the wait-list condition will receive the intervention after 12-month follow-up.

Primary Outcomes

Measure
Anxiety Disorders Interview Schedule - Child and Parent Version
time frame: At 12-month follow up

Secondary Outcomes

Measure
The Spence Children's Anxiety Scale
time frame: 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
The Rearing Behavior Questionnaire
time frame: 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
State-Trait Anxiety Inventory
time frame: 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
Quality of Life Inventory
time frame: Change from baseline in quality of life scores at 12 months follow-up

Eligibility Criteria

Male or female participants of any age.

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.

Additional Information

Official title Selective Prevention of Anxiety Disorders in Children: A Randomized Controlled Preliminary Study of a Parent Training Intervention for Anxious Parents
Principal investigator Ata Ghaderi, PhD
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Karolinska Institutet.