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CompletedNCT02386410Updated Nov 13, 2017

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

An interventional study of Group parent training for anxious parents and Internet delivered parent training for anxious parents in Anxiety Disorders, sponsored by Karolinska Institutet. Completed at 1 site in Sweden. Per ClinicalTrials.gov, last updated 2017-11-13.

Sponsored by Karolinska Institutet · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Sex
All
01

Study 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.

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Conditions studied

  • Anxiety Disorders

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03

In context

Anxiety Disorders

4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.

This study's enrollment of 40 is below the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

Karolinska Institutet is the lead sponsor of 1,113 studies on the registry; 267 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Presence of very aggravated family situations, such as parent substance abuse or severe depression, or domestic violence.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    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.

    Behavioral: Group parent training for anxious parents

  • Experimental
    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.

    Behavioral: Internet delivered parent training for anxious parents

  • No intervention
    Wait-list

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

Interventions

  • BehavioralGroup parent training for anxious parents
  • BehavioralInternet delivered parent training for anxious parents
06

What researchers measure

Primary outcomes

  1. Anxiety Disorders Interview Schedule - Child and Parent Version

    Time frame: At 12-month follow up

Secondary outcomes

  1. The Spence Children's Anxiety Scale

    Rated by the child and the parent independently

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

  2. Children Depression Inventory

    Rated by the child

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

  3. The Rearing Behavior Questionnaire

    Rated by parents

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

  4. Strengths and Difficulties Questionnaire

    Rated by parents

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

  5. State-Trait Anxiety Inventory

    Rated by parents

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

  6. Montgomery-Åsberg Depression Rating Scale

    Rated by parents

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

  7. Quality of Life Inventory

    Rated by parents

    Time frame: Change from baseline in quality of life scores at 12 months follow-up

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Study locations

1 site
  • Karolinska Institutet
    Solna, 17177, Sweden
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 13, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02386410
Lead sponsor
Karolinska Institutet
Responsible party
Ata Ghaderi (Professor, PhD, Karolinska Institutet) — Principal investigator
First posted
Mar 11, 2015
Start date
Aug 2015
Primary completion
Dec 2016
Completion
Jan 2017
Last update
Nov 13, 2017

Study contacts

Ata Ghaderi, PhD
principal investigator · Karolinska Institutet

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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