MedDataX Logo

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

NCT ID: NCT02386410

Last Updated: 2017-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2017-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anxiety Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group parent training

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 Type EXPERIMENTAL

Group parent training for anxious parents

Intervention Type BEHAVIORAL

Internet delivered parent training

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.

Group Type EXPERIMENTAL

Internet delivered parent training for anxious parents

Intervention Type BEHAVIORAL

Wait-list

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Group parent training for anxious parents

Intervention Type BEHAVIORAL

Internet delivered parent training for anxious parents

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ata Ghaderi

Professor, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ata Ghaderi, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Karolinska Institutet

Solna, , Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Sweden

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AGJA-02

Identifier Type: -

Identifier Source: org_study_id