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

NCT02386410 | Completed

• 1 other identifier: AGJA-02
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety Disorders

Outcome Measures

Primary Outcomes (1)

• Anxiety Disorders Interview Schedule - Child and Parent Version

  At 12-month follow up

Secondary Outcomes (7)

• The Spence Children's Anxiety Scale

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

• Children Depression Inventory

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

• The Rearing Behavior Questionnaire

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

• Strengths and Difficulties Questionnaire

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

• State-Trait Anxiety Inventory

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

Study Arms (3)

Group parent training

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.

Behavioral: Group parent training for anxious parents

Internet delivered parent training

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.

Behavioral: Internet delivered parent training for anxious parents

Wait-list

NO INTERVENTION

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

Interventions

Group parent training for anxious parents BEHAVIORAL

Group parent training

Internet delivered parent training for anxious parents BEHAVIORAL

Internet delivered parent training

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Presence of very aggravated family situations, such as parent substance abuse or severe depression, or domestic violence.

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karolinska Institutet

Solna, 17177, Sweden

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Ata Ghaderi, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, PhD

Study Record Dates

• First Submitted: March 5, 2015
• First Posted: March 11, 2015
• Study Start: August 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: January 1, 2017
• Last Updated: November 13, 2017

Record last verified: 2017-11

Locations

SE (1)