Anxiety DisordersNCT04722731
Prevention of Childhood Anxiety Disorders in Offspring of Anxious Parents
A study testing Confident Parents - Brave Children (CPBT) and Self-help book "What all parents ought to know" in people with Anxiety Disorders, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
This study aims to expand the evidence of prevention of anxiety disorders in children. Children of anxious parents are at increased risk of developing anxiety disorders. Twin studies support a direct environmental transmission of anxiety between parent and child, and a main mechanism is suggested to be the parenting… Read more about this study
- Who is it for?
- Ages 5 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety Disorders
- What is being tested?
- Confident Parents - Brave Children (CPBT) and Self-help book "What all parents ought to know"
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 215 participants
- Where
- 1 siteSweden
- Study dates
- 15 Feb 2021to 1 Jul 2025
- 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 5 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The parent suffers from exaggerated worry or anxiety
- The parent speaks and reads Swedish
- The child is 5-9 years old
- The child receives a clinicians assigned clinical severity rating (CSR) of 1 to 3 on anxiety disorders in ADIS-C (subclinical symptoms of anxiety)
Who cannot join
- Current or recent parental alcohol or substance abuse
- The parent suffer from severe psychiatric conditions (e.g.current or recent psychotic or manic/hypomanic symptoms, severe depression or increased risk of suicide)
- Social conditions that would obstruct from participation (e.g.ongoing custody dispute, domestic violence, ongoing investigation of child neglect through social services)
- The child suffers from/is currently in treatment for an anxiety disorder or depression
- The child is currently undergoing a neuropsychological evaluation
- The child has no symptoms of anxiety at all (the child receives a clinicians assigned CSR of 0 on all anxiety disorders in the ADIS-C interview )
- The child meet criteria for an anxiety disorder (the child receives a clinicians assigned CSR of 4 or above on any anxiety disorder in ADIS-C interview )
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention of Childhood Anxiety Disorders in Offspring of Anxious Parents - a Randomized Controlled Trial
This study aims to expand the evidence of prevention of anxiety disorders in children. Children of anxious parents are at increased risk of developing anxiety disorders. Twin studies support a direct environmental transmission of anxiety between parent and child, and a main mechanism is suggested to be the parenting style of anxious parents, characterised by criticism and rejection, overprotection and modelling of anxiety.
This study will take a novel approach to prevent childhood anxiety disorders by evaluating the Confident Parents - Brave Children (CPBC) program, a parent program targeting anxious parents, in a randomised controlled trial (RCT).
Read the detailed description
RESEARCH QUESTIONS
- Is the CPBC-program effective in preventing childhood anxiety disorders within a period of 12 and 36 months respectively, compared to a self-help parenting book?
- Is the CPBC-program effective in preventing childhood anxiety symptoms within a period of 12 and 36 months respectively, compared to a self-help parenting book?
- Is the effect moderated by severity of parental anxiety, child anxiety symptoms at baseline, or gender or age of the child?
- Is the study effective in increasing parental self efficacy?
- Is the effect of CPBC-program mediated by changes in parental criticism and rejection, overprotection, parental modelling of anxiety or parental accommodation?
- Is the CPBC-program cost-effective?
DESIGN The first study is a full scale parallel randomised controlled trial (allocation ratio 1:1). This study will include follow-up assessments after 12 and 36 months and will evaluate the relative efficacy of the CPBC-program versus an active control group (self-help book). The second part includes a mediation analysis and the third part is a within trial economic evaluation comparing the outcomes and costs between the CPBC-program and control using two types of analyses (cost-utility analysis and cost-consequence analysis).
POWER To have an 80% power to detect a significant (p ≤ 0.05) small to moderate difference (standardised mean difference = 0.4) the investigators will need to recruit 194 children. Given an anticipated attrition of 10%, the investigators will aim at including a total of 216 children. Participants will be recruited through advertisements. The participants will be randomly allocated to either (1) CPBC-program or (2) reading a self-help book.
- Conditions
- Anxiety Disorders
- Being tested
- Confident Parents - Brave Children (CPBT), Self-help book "What all parents ought to know"
- Keywords
- Prevention, Childhood anxiety, Parent program
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Confident Parents - Brave Children (CPBT)Behavioural
Session 1: Psychoeducation.
Session 2: How to decrease criticism and rejection. Skills that provide a warm parenting style and acceptance of the child: validation and child directed play/activities.
Session 3: Strategies to increase the autonomy of the child. The parents will learn how to use a stepladder approach to decrease overprotective behaviours.
Session 4: How to decrease modelling of anxious behaviours and how to be a brave role model.
Session 5: How to recognise and respond when your child is anxious. How to help your child approach new or scary things by using a stepladder approach.
Session 6: Review of the principles and skills learned during the program. The group members will make a plan for how to continue the work on their own.
Self-help book "What all parents ought to know"Behavioural
Participants in the control group will receive a self-help parenting book containing general research-based parenting strategies. They will be instructed to read the book within the 10 weeks from baseline to post.
| Study group | Role | What they receive |
|---|---|---|
| Confident Parents - Brave Children | Experimental | The Confident Parents - Brave Children (CPBT) is a group parent training targeted to anxious parents, delivered by a psychologist via video conference (the Zoom software solution).
The CPBT will comprise six 120-minutes digital sessions. One month after the last group session, all parents will be offered to have an individual booster session with a psychologist over Zoom. Receives: Behavioral: Confident Parents - Brave Children (CPBT) |
| Self-help book | Active comparator | In the control group, participants will receive a parenting book, titled "What all parents ought to know". This is a self-help book for parents, partly based on the scientifically evaluated parent program "All Children in Focus". Receives: Behavioral: Self-help book "What all parents ought to know" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in severity of childhood anxiety disorder as rated by clinician at 12-month, and 36 month follow-up
Clinical Severity Ratings (CSR, ranging from 0 to 8, where a value of 4 and higher indicate that the child meet criteria for an anxiety disorder). The CSR is extracted from the Anxiety Disorders Interview Schedule - Schedule for Children (ADIS-C). The CRS is rated by clinician based on interviewing with primary caregiver.
Measured: Base-line assessment, 12 month follow-up, 36 month follow-up
Secondary outcomes (11)
Change in Child Health Utility-9 Dimensions (CHU9D) at post-intervention, 12-month, and 36 month follow-up
CHU9D is a validated parent-rated questionnaire of the child's quality of life, including 9 items (each item scored 1-5 where lower scores indicates better quality of life).
Measured: Base-line assessment, post-intervention, 12 month follow-up, 36 month follow-up
Change in EQ5D at post-intervention, at post-intervention, 12-month, and 36 month follow-up
EQ5D is a validated self-rated questionnaire of the parent's quality of life, including 5 items (each item scored 1-3 where lower scores indicates better quality of life).
Measured: Base-line assessment, post-intervention, 12 month follow-up, 36 month follow-up
Change in Expressed Emotion Adjective Checklist (EEAC) at post-intervention, 12-month, and 36 month follow-up
The EEAC is a validated self-rated questionnaire of the parent's positive and negative emotions directed towards the child. The EEAC include 20 adjectives (each scored 1-8 where 1 indicates never and 8 always.
Measured: Base-line assessment, post-intervention, 12 month follow-up, 36 month follow-up
Change in the Revised Parental Overprotective Scale (RPOS) at post-intervention, 12-month, and 36 month follow-up
RPOS is a revised version of the validated self-rated questionnaire of the parent's overprotective behaviors, including 11 items (each item scored 1-5 where higher scores indicates more overprotective behaviors).
Measured: Base-line assessment, post-intervention, 12 month follow-up, 36 month follow-up
Change in the Modelling of Parental Anxiety Questionnaire (MPAQ) at post-intervention, 12-month, and 36 month follow-up
MPAQ is a self-rated questionnaire of the parent's modelling of anxious and non-anxious behaviours (two different sub-scales), including 7+9 items (each item scored 1-5 where higher scores indicates more modelling).
Measured: Base-line assessment, post-intervention, 12 month follow-up, 36 month follow-up
Change in the Screen for Child Anxiety Related Disorders Revised (SCARED-R) at post-intervention, 12-month, and 36 month follow-up
SCARED-R is a validated parent-rated questionnaire of the child's anxiety symptoms including 41 items (each item scored 0-2 where higher scores indicates more anxiety symptoms).
Measured: Base-line assessment, post-intervention, 12 month follow-up, 36 month follow-up
Change in the PHQ 9 at post-intervention, 12-month, and 36 month follow-up Change in the Patient Health Questionnaire (PHQ-9) at post-intervention, 12-month, and 36 month follow-up
The PHQ-9 is a validated self-rated questionnaire of the parent's depression symptoms, including 9 items, (each item scored 0-3 where higher scores indicates more depressive symptoms).
Measured: Base-line assessment, post-intervention, 12 month follow-up, 36 month follow-up
Change in PROMIS-Anxiety Short Form at post-intervention, 12-month, and 36 month follow-up
The PROMIS Anxiety Short Form is a validated self-rated questionnaire of the parent's anxiety symptoms, including 8 items, (each item scored 1-5 where higher scores indicates more anxiety symptoms).
Measured: Base-line assessment, post-intervention, 12 month follow-up, 36 month follow-up
Change in Family Accommodation Scale-Anxiety Parent Report (FASA-PR) at post-intervention, 12-month, and 36 month follow-up
The FASA-PR is a validated self-rated questionnaire of the parent's accommodation to the child's anxiety, including 13 items (each item scored 0-4 where higher scores indicates more accommodation).
Measured: Base-line assessment, post-intervention, 12 month follow-up, 36 month follow-up
Change in Parenting Sense of Competence Scale (PSOC) at post-intervention, 12-month, and 36 month follow-up
PSOC is a validated self-reported questionnaire of the parent's sense of competence, including 11 items (each item scored 1-6 where higher scores indicates more sense of competence).
Measured: Base-line assessment, post-intervention, 12 month follow-up, 36 month follow-up
Use of societal resources past three months (an adapted version of the TIC-P questionnaire)
TIC-P (Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness) is a questionnaire including questions about healthcare social support medications, parental absence from work, absence from school and productivity loss in school.
Measured: Assessed at Base-line assessment, post-intervention, 12 month follow-up, 36 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start15 Feb 2021
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johan Åhlén, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04722731
- Sponsor's protocol ID
- JASE01
- Status last verified
- Oct 2023
- First submitted
- 20 Jan 2021
- Last updated
- 4 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Elfstrom S, Rosengren A, Andersson R, Engelbrektsson J, Isaksson A, Meregalli M, van Leuven L, Lalouni M, Ost LG, Ghaderi A, Ahlen J. Evaluating a program to prevent anxiety in children of anxious parents: a randomized controlled trial. J Child Psychol Psychiatry. 2025 Sep;66(9):1345-1356. doi: 10.1111/jcpp.14151. Epub 2025 Mar 12.
PubMed 40077809
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Childhood Anxiety Disorders in Offspring of Anxious Parents - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04722731
- Acronym / sponsor ID
- JASE01
- Conditions
- Anxiety Disorders
- Keywords
- Prevention, Childhood anxiety, Parent program
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 215 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 25 Jan 2021 (actual)
- 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.
This study aims to expand the evidence of prevention of anxiety disorders in children. Children of anxious parents are at increased risk of developing anxiety disorders. Twin studies support a direct environmental transmission of anxiety between parent and child, and a main mechanism is suggested to be the parenting style of anxious parents, characterised by criticism and rejection, overprotection and modelling of anxiety.
This study will take a novel approach to prevent childhood anxiety disorders by evaluating the Confident Parents - Brave Children (CPBC) program, a parent program targeting anxious parents, in a randomised controlled trial (RCT).
Detailed description
RESEARCH QUESTIONS
- Is the CPBC-program effective in preventing childhood anxiety disorders within a period of 12 and 36 months respectively, compared to a self-help parenting book?
- Is the CPBC-program effective in preventing childhood anxiety symptoms within a period of 12 and 36 months respectively, compared to a self-help parenting book?
- Is the effect moderated by severity of parental anxiety, child anxiety symptoms at baseline, or gender or age of the child?
- Is the study effective in increasing parental self efficacy?
- Is the effect of CPBC-program mediated by changes in parental criticism and rejection, overprotection, parental modelling of anxiety or parental accommodation?
- Is the CPBC-program cost-effective?
DESIGN The first study is a full scale parallel randomised controlled trial (allocation ratio 1:1). This study will include follow-up assessments after 12 and 36 months and will evaluate the relative efficacy of the CPBC-program versus an active control group (self-help book). The second part includes a mediation analysis and the third part is a within trial economic evaluation comparing the outcomes and costs between the CPBC-program and control using two types of analyses (cost-utility analysis and cost-consequence analysis).
POWER To have an 80% power to detect a significant (p ≤ 0.05) small to moderate difference (standardised mean difference = 0.4) the investigators will need to recruit 194 children. Given an anticipated attrition of 10%, the investigators will aim at including a total of 216 children. Participants will be recruited through advertisements. The participants will be randomly allocated to either (1) CPBC-program or (2) reading a self-help book.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Confident Parents - Brave Children | Experimental | Behavioral: Confident Parents - Brave Children (CPBT)The Confident Parents - Brave Children (CPBT) is a group parent training targeted to anxious parents, delivered by a psychologist via video conference (the Zoom software solution). The CPBT will comprise six 120-minutes digital sessions. One month after the last group session, all parents will be offered to have an individual booster session with a psychologist over Zoom. |
| Self-help book | Active comparator | Behavioral: Self-help book "What all parents ought to know"In the control group, participants will receive a parenting book, titled "What all parents ought to know". This is a self-help book for parents, partly based on the scientifically evaluated parent program "All Children in Focus". |
Who may qualify
- Ages
- 5 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- The parent suffers from exaggerated worry or anxiety
- The parent speaks and reads Swedish
- The child is 5-9 years old
- The child receives a clinicians assigned clinical severity rating (CSR) of 1 to 3 on anxiety disorders in ADIS-C (subclinical symptoms of anxiety)
Key exclusion criteria (7 listed)
- Current or recent parental alcohol or substance abuse
- The parent suffer from severe psychiatric conditions (e.g.current or recent psychotic or manic/hypomanic symptoms, severe depression or increased risk of suicide)
- Social conditions that would obstruct from participation (e.g.ongoing custody dispute, domestic violence, ongoing investigation of child neglect through social services)
- The child suffers from/is currently in treatment for an anxiety disorder or depression
- The child is currently undergoing a neuropsychological evaluation
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 |
|---|---|---|
| Confident Parents - Brave Children (CPBT)Session 1: Psychoeducation. Session 2: How to decrease criticism and rejection. Skills that provide a warm parenting style and acceptance of the child: validation and child directed play/activities. Session 3: Strategies to increase the autonomy of the child. The parents will learn how to use a stepladder approach to decrease overprotective behaviours. Session 4: How to decrease modelling of anxious behaviours and how to be a brave role model. Session 5: How to recognise and respond when your child is anxious. How to help your child approach new or scary things by using a stepladder approach. Session 6: Review of the principles and skills learned during the program. The group members will make a plan for how to continue the work on their own. | Behavioural | Confident Parents - Brave Children |
| Self-help book "What all parents ought to know"Participants in the control group will receive a self-help parenting book containing general research-based parenting strategies. They will be instructed to read the book within the 10 weeks from baseline to post. | Behavioural | Self-help book |
Primary outcome
Change in severity of childhood anxiety disorder as rated by clinician at 12-month, and 36 month follow-up
Time frame: Base-line assessment, 12 month follow-up, 36 month follow-up
Clinical Severity Ratings (CSR, ranging from 0 to 8, where a value of 4 and higher indicate that the child meet criteria for an anxiety disorder). The CSR is extracted from the Anxiety Disorders Interview Schedule - Schedule for Children (ADIS-C). The CRS is rated by clinician based on interviewing with primary caregiver.
11 secondary outcomes
Change in Child Health Utility-9 Dimensions (CHU9D) at post-intervention, 12-month, and 36 month follow-up
Time frame: Base-line assessment, post-intervention, 12 month follow-up, 36 month follow-up
Change in EQ5D at post-intervention, at post-intervention, 12-month, and 36 month follow-up
Time frame: Base-line assessment, post-intervention, 12 month follow-up, 36 month follow-up
Change in Expressed Emotion Adjective Checklist (EEAC) at post-intervention, 12-month, and 36 month follow-up
Time frame: Base-line assessment, post-intervention, 12 month follow-up, 36 month follow-up
Change in the Revised Parental Overprotective Scale (RPOS) at post-intervention, 12-month, and 36 month follow-up
Time frame: Base-line assessment, post-intervention, 12 month follow-up, 36 month follow-up
Change in the Modelling of Parental Anxiety Questionnaire (MPAQ) at post-intervention, 12-month, and 36 month follow-up
Time frame: Base-line assessment, post-intervention, 12 month follow-up, 36 month follow-up
Change in the Screen for Child Anxiety Related Disorders Revised (SCARED-R) at post-intervention, 12-month, and 36 month follow-up
Time frame: Base-line assessment, post-intervention, 12 month follow-up, 36 month follow-up
Change in the PHQ 9 at post-intervention, 12-month, and 36 month follow-up Change in the Patient Health Questionnaire (PHQ-9) at post-intervention, 12-month, and 36 month follow-up
Time frame: Base-line assessment, post-intervention, 12 month follow-up, 36 month follow-up
Change in PROMIS-Anxiety Short Form at post-intervention, 12-month, and 36 month follow-up
Time frame: Base-line assessment, post-intervention, 12 month follow-up, 36 month follow-up
Change in Family Accommodation Scale-Anxiety Parent Report (FASA-PR) at post-intervention, 12-month, and 36 month follow-up
Time frame: Base-line assessment, post-intervention, 12 month follow-up, 36 month follow-up
Change in Parenting Sense of Competence Scale (PSOC) at post-intervention, 12-month, and 36 month follow-up
Time frame: Base-line assessment, post-intervention, 12 month follow-up, 36 month follow-up
Use of societal resources past three months (an adapted version of the TIC-P questionnaire)
Time frame: Assessed at Base-line assessment, post-intervention, 12 month follow-up, 36 month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
- Derived from this study: PubMed 40077809Elfstrom S, Rosengren A, Andersson R, Engelbrektsson J, Isaksson A, Meregalli M, van Leuven L, Lalouni M, Ost LG, Ghaderi A, Ahlen J. Evaluating a program to prevent anxiety in children of anxious parents: a randomized controlled trial. J Child Psychol Psychiatry. 2025 Sep;66(9):1345-1356. doi: 10.1111/jcpp.14151. Epub 2025 Mar 12.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Confident Parents - Brave Children (CPBT) and Self-help book "What all parents ought to know" 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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 4 Oct 2023. 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?
Results are not available in the source record.
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?
Change in severity of childhood anxiety disorder as rated by clinician at 12-month, and 36 month follow-up (time frame: Base-line assessment, 12 month follow-up, 36 month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04722731, which also lists 1 linked publication.
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 4 Oct 2023.