search
Back to results

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

Primary Purpose

Anxiety Disorders

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Group parent training for anxious parents
Internet delivered parent training for anxious parents
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anxiety Disorders

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Karolinska Institutet

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Group parent training

Internet delivered parent training

Wait-list

Arm Description

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.

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.

Parents in the wait-list condition will receive the intervention after 12-month follow-up.

Outcomes

Primary Outcome Measures

Anxiety Disorders Interview Schedule - Child and Parent Version

Secondary Outcome Measures

The Spence Children's Anxiety Scale
Rated by the child and the parent independently
Children Depression Inventory
Rated by the child
The Rearing Behavior Questionnaire
Rated by parents
Strengths and Difficulties Questionnaire
Rated by parents
State-Trait Anxiety Inventory
Rated by parents
Montgomery-Åsberg Depression Rating Scale
Rated by parents
Quality of Life Inventory
Rated by parents

Full Information

First Posted
March 5, 2015
Last Updated
November 9, 2017
Sponsor
Karolinska Institutet
search

1. Study Identification

Unique Protocol Identification Number
NCT02386410
Brief Title
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

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
August 2015 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group parent training
Arm Type
Experimental
Arm Description
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.
Arm Title
Internet delivered parent training
Arm Type
Experimental
Arm Description
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.
Arm Title
Wait-list
Arm Type
No Intervention
Arm Description
Parents in the wait-list condition will receive the intervention after 12-month follow-up.
Intervention Type
Behavioral
Intervention Name(s)
Group parent training for anxious parents
Intervention Type
Behavioral
Intervention Name(s)
Internet delivered parent training for anxious parents
Primary Outcome Measure Information:
Title
Anxiety Disorders Interview Schedule - Child and Parent Version
Time Frame
At 12-month follow up
Secondary Outcome Measure Information:
Title
The Spence Children's Anxiety Scale
Description
Rated by the child and the parent independently
Time Frame
Change from baseline in anxiety symptom scores at 12 months follow-up
Title
Children Depression Inventory
Description
Rated by the child
Time Frame
Change from baseline in depressive symptom scores at 12 months follow-up
Title
The Rearing Behavior Questionnaire
Description
Rated by parents
Time Frame
Change from baseline in rearing behavior scores at 12 months follow-up
Title
Strengths and Difficulties Questionnaire
Description
Rated by parents
Time Frame
Change from baseline in dfficulties scores at 12 months follow-up
Title
State-Trait Anxiety Inventory
Description
Rated by parents
Time Frame
Change from baseline in anxiety symptom scores at 12 months follow-up
Title
Montgomery-Åsberg Depression Rating Scale
Description
Rated by parents
Time Frame
Change from baseline in depressive symptom scores at 12 months follow-up
Title
Quality of Life Inventory
Description
Rated by parents
Time Frame
Change from baseline in quality of life scores at 12 months follow-up

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ata Ghaderi, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska Institutet
City
Solna
ZIP/Postal Code
17177
Country
Sweden

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs