Anxiety DisordersNCT02386410
Selective Prevention of Anxiety Disorders in Children: A Parent Training Intervention for Anxious Parents
A study testing Group parent training for anxious parents and Internet delivered parent training for anxious parents in people with Anxiety Disorders, run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Anxiety Disorders
- What is being tested?
- Group parent training for anxious parents and Internet delivered parent training for anxious parents
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2015to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Presence of very aggravated family situations, such as parent substance abuse or severe depression, or domestic violence.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Selective Prevention of Anxiety Disorders in Children: A Randomized Controlled Preliminary Study of a Parent Training Intervention for Anxious Parents
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
- Being tested
- Group parent training for anxious parents, Internet delivered parent training for anxious parents
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group parent training for anxious parentsBehavioural
Internet delivered parent training for anxious parentsBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety Disorders Interview Schedule - Child and Parent Version
Measured: At 12-month follow up
Secondary outcomes (7)
The Spence Children's Anxiety Scale
Rated by the child and the parent independently
Measured: Change from baseline in anxiety symptom scores at 12 months follow-up
Children Depression Inventory
Rated by the child
Measured: Change from baseline in depressive symptom scores at 12 months follow-up
The Rearing Behavior Questionnaire
Rated by parents
Measured: Change from baseline in rearing behavior scores at 12 months follow-up
Strengths and Difficulties Questionnaire
Rated by parents
Measured: Change from baseline in dfficulties scores at 12 months follow-up
State-Trait Anxiety Inventory
Rated by parents
Measured: Change from baseline in anxiety symptom scores at 12 months follow-up
Montgomery-Åsberg Depression Rating Scale
Rated by parents
Measured: Change from baseline in depressive symptom scores at 12 months follow-up
Quality of Life Inventory
Rated by parents
Measured: Change from baseline in quality of life scores at 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2015 (estimated)
- Study startAug 2015
- Primary completionDec 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ata Ghaderi, Karolinska Institutet
- Investigators
- Ata Ghaderi, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02386410
- Sponsor's protocol ID
- AGJA-02
- Status last verified
- Nov 2017
- First submitted
- 5 Mar 2015
- Last updated
- 13 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective Prevention of Anxiety Disorders in Children: A Randomized Controlled Preliminary Study of a Parent Training Intervention for Anxious Parents
- ClinicalTrials.gov ID
- NCT02386410
- Acronym / sponsor ID
- AGJA-02
- Conditions
- Anxiety Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 11 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group parent training | Experimental | Behavioral: Group parent training for anxious parentsThe 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. |
| Internet delivered parent training | Experimental | Behavioral: Internet delivered parent training for anxious parentsIn 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. |
| Wait-list | No intervention | –Parents in the wait-list condition will receive the intervention after 12-month follow-up. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Presence of very aggravated family situations, such as parent substance abuse or severe depression, or domestic violence.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group parent training for anxious parents | Behavioural | Group parent training |
| Internet delivered parent training for anxious parents | Behavioural | Internet delivered parent training |
Primary outcome
Anxiety Disorders Interview Schedule - Child and Parent Version
Time frame: At 12-month follow up
7 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ata Ghaderi, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group parent training for anxious parents and Internet delivered parent training for anxious parents in people with Anxiety Disorders, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety Disorders Interview Schedule - Child and Parent Version (time frame: At 12-month follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2017.