Child AnxietyPWANCT04755933
Parenting With Anxiety: Helping Anxious Parents Raise Confident Children
A study testing Raising Confident Children Course in people with Child Anxiety and Parent Anxiety, run by University of Sussex at 1 site in United Kingdom.
Trial summary
This is a randomised controlled trial of an intervention to reduce symptoms of anxiety in the children of anxious parents. Parents will participate in an online intervention which helps them develop a calm, consistent, behaviour management style. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Child Anxiety, Parent Anxiety, Parental Wellbeing
- What is being tested?
- Raising Confident Children Course
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,508 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Feb 2021to Apr 2023
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Be a parent (any gender, adoptive/biological/step/foster/grandparent) aged 16+, of a child aged 2 to 11 years (inclusive). The index parent must have at least 50 days' contact with the index child per year and confirm that they see enough of the child to report on the child's current anxiety level.
- Index parent must be a UK resident.
- Self-report subjectively substantial levels of current or lifetime anxiety.
- Able to commit to completion of measures at (up to) three time points even if allocated to the control arm.
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
Abby Dunn contact
United Kingdom1 site, 1 recruiting
- Recruiting
University of Sussex
Brighton, BN1 9RH
Amy Arbon, a.arbon@nhs.net
Abby Dunn, abby.dunn@sussex.ac.uk
About this study
Official title: A Randomised Controlled Trial of an Online Intervention to Prevent Anxiety in the Children of Anxious Parents
This is a randomised controlled trial of an intervention to reduce symptoms of anxiety in the children of anxious parents. Parents will participate in an online intervention which helps them develop a calm, consistent, behaviour management style. The parents will be randomised to the intervention or a control group with no intervention. The intervention itself will undergo a component analysis to determine whether some modules are more effective than others.
Read the detailed description
The study is an online course (derived from an existing evidence-based face-to-face workshop designed and evaluated by the C.I) which aims to reduce symptoms of anxiety in the children of anxious parents. It is a learning tool to help parents to understand the basic processes involved in children's anxiety, to develop a calm, consistent, behaviour management style and to learn skills for responding to difficult emotion in their children.
The whole study takes place online, allowing the participants to sign up, run through some brief eligibility questions, read the study information and provide consent.
Once enrolled in the study, there is a series of baseline questionnaires. The participant also has the option to nominate someone who also knows their child well (e.g. a co-parent, a family member or close friend) to participate in the study with them and to complete a small number of questionnaires. This will help to give us a broader, more objective picture of the child, but is an optional part of the study. 48 hours later (to allow time for the participants to contact the co-respondent if they choose) the index participant will be randomised to one of two groups: either the intervention (the online course), or the control group where they do not receive the intervention.
Those in the intervention will be randomised to receive 8 out of 9 modules of the course, with a suggested time frame of one or two modules a week, each module taking about 30 minutes, with some home-practice tasks in-between.
Both the intervention group and the control group participants will be contacted again after 6 months to complete a set of follow-up questionnaires (similar to those completed at baseline). Depending on when each participant joins the trial, they may be contacted a third time towards the end of the life of the study, to complete another set of questionnaires,9-21 months after their first.
- Conditions
- Child Anxiety, Parent Anxiety, Parental Wellbeing, Child Wellbeing
- Being tested
- Raising Confident Children Course
- Keywords
- Parenting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Raising Confident Children CourseBehavioural
An online learning tool consisting of 8 different modular components, designed to reduce the transmission of anxiety from parents to children. The modular components include: a core starter about anxiety, the role of avoidance, using play to develop childrens confidence, using Emotion Coaching with children, managing difficult behaviour, the role of sleep, exercise and diet, reducing overprotection, modelling confident behaviour and managing difficult behaviour.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | An online learning tool, designed to helps parents develop a calm, consistent behaviour management style, whilst learning skills to discourage children's avoidance. Receives: Behavioral: Raising Confident Children Course |
| Control | No intervention | The participants in the control arm will not receive access to the online course, but will complete the same sets of questionnaires at each of the timepoints. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in child anxiety
Measured using the Spence Children's Anxiety Scale (SCAS-P and Preschool SCAS if the child is aged 6 or under).
SCAS-P: Minimum 0 Maximum 114. A higher total score is indicative of higher level of child anxiety. T scores used to indicate clinical levels of anxiety however this is a screen not a diagnostic instrument.
SCAS Preschool: Minimum 0 Maximum 112. A higher total indicates a higher level of pre-school child anxiety. A score of 1SD above the mean for a subscale or the total score indicates clinical investigated would be warranted.
Measured: Baseline, 6 months, and up to 21 months.
Secondary outcomes (6)
Change in parent anxiety and parental wellbeing
Measured using Screen for Child Anxiety Related Emotional Disorder (SCARED-A): Minimum 0, Maximum 142. . Higher total score (>30) predictive of a current anxiety disorder. Higher subscale scores associated with elevated anxiety symptoms of clinically defines anxiety disorders.
Measured: Baseline, 6 months, and up to 21 months.
Change in parent anxiety and parental wellbeing
Measured using Short Warwick Edinburgh Mental Wellbeing Scale. Minimum score 7. Maximum score 35. Raw scores converted into metric scores. Higher scores indicate higher positive mental wellbeing.
Measured: Baseline, 6 months, and up to 21 months.
Change in child wellbeing and health
Measured using Pediatric Symptom Checklist (PSC-17). Minimum 0. Max 35. A higher score indicates a worse psychosocial functioning. Scores predictive of psychopathology at following levels: Internalizing score positive if ≥ 5 PSC-17 Externalizing score positive if ≥ 7 PSC-17 Attention score positive if ≥7 PSC-17 Total score positive if ≥15.
Measured: Baseline, 6 months, and up to 21 months.
Change in child wellbeing and health
Measured using EQ-5D-Y Proxy. Minimum 11111 Maximum 33333. A higher score indicates a worse health status.
Measured: Baseline, 6 months, and up to 21 months.
Change in anxiogenic parenting behaviours
Measure using Comprehensive Parenting Behaviour Questionnaire (CPBQ). Minimum 104. Maximum 520. The scale is split into broad dimensions, subscales and sub subscales. Higher scores are associated with greater level of parenting behaviour under investigation in the given subscale: both positive (e.g. warmth) and challenging (e.g. overprotection).
Measured: Baseline, 6 months, and up to 21 months
Change in anxiogenic parenting behaviours
Measured using a parenting experience scale (constructed specifically for this study, divided into 8 modules).
Core: Min 1 Max 5. Higher score = Positive. Module A: Min 1 Max 5. Higher score = Positive (Q2: R scored). Module B: Min 1 Max 5. Higher score = Positive (all are R scored). Module C: Min 1 Max 5. Higher score = Positive. Module D: Q1, Q3, Q4: Min 1 Max 5. Higher score = Positive (Q4: R scored). Module D Q2: Min 1 Max 5. Higher score = Positive. Module E: Min 1 Max 4. Higher score = Negative (Q3: R scored). Module F: Min 1 Max 5. Higher score = Positive (Q1 and Q4: R scored). Module G Q1: Min 1 Max 5. Higher score = Positive (Q1: R scored). Module GQ2: Min 3 Max 5: Higher score Negative (Note: Both ends of the scale are maladaptive). Module G Q3: Min 1 Max 5. Higher score = Negative.
Measured: Baseline, 6 months, and up to 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start15 Feb 2021
- Primary completionApr 2023 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Child AnxietyStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 3,508 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sussex
- Sponsor type
- University, hospital or other
- Collaborators
- Kavli Trust, Brighton & Sussex Medical School
- Responsible party
- Sponsor
- Investigators
- Sam Cartright-Hatton, Principal investigator, University of Sussex
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04755933
- Sponsor's protocol ID
- ER/SC430/1
- Acronym
- PWA
- Status last verified
- May 2022
- First submitted
- 2 Feb 2021
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will not be shared on an individual basis. Anonymised study data will be archived at the end of the study through the University of Sussex data repository, Figshare.
Publications
Dunn A, Alvarez J, Arbon A, Bremner S, Elsby-Pearson C, Emsley R, Jones C, Lawrence P, Lester KJ, Morson N, Simner J, Thomson A, Cartwright-Hatton S. Effectiveness of an unguided modular online intervention for highly anxious parents in preventing anxiety in their children: a parallel group randomised controlled trial. Lancet Reg Health Eur. 2024 Sep 4;45:101038. doi: 10.1016/j.lanepe.2024.101038. eCollection 2024 Oct.
PubMed 39291249Dunn A, Alvarez J, Arbon A, Bremner S, Elsby-Pearson C, Emsley R, Jones C, Lawrence P, Lester KJ, Majdandzic M, Morson N, Perry N, Simner J, Thomson A, Cartwright-Hatton S. Effectiveness of a Web-Based Intervention to Prevent Anxiety in the Children of Parents With Anxiety: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2022 Nov 10;11(11):e40707. doi: 10.2196/40707.
PubMed 36355406
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of an Online Intervention to Prevent Anxiety in the Children of Anxious Parents
- ClinicalTrials.gov ID
- NCT04755933
- Acronym / sponsor ID
- PWA / ER/SC430/1
- Conditions
- Child Anxiety, Parent Anxiety, Parental Wellbeing, Child Wellbeing
- Keywords
- Parenting
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,508 participants (estimated)
- Lead sponsor
- University of SussexUniversity, hospital or other
- Collaborators
- Kavli Trust, Brighton & Sussex Medical School
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 16 Feb 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 is a randomised controlled trial of an intervention to reduce symptoms of anxiety in the children of anxious parents. Parents will participate in an online intervention which helps them develop a calm, consistent, behaviour management style. The parents will be randomised to the intervention or a control group with no intervention. The intervention itself will undergo a component analysis to determine whether some modules are more effective than others.
Detailed description
The study is an online course (derived from an existing evidence-based face-to-face workshop designed and evaluated by the C.I) which aims to reduce symptoms of anxiety in the children of anxious parents. It is a learning tool to help parents to understand the basic processes involved in children's anxiety, to develop a calm, consistent, behaviour management style and to learn skills for responding to difficult emotion in their children.
The whole study takes place online, allowing the participants to sign up, run through some brief eligibility questions, read the study information and provide consent.
Once enrolled in the study, there is a series of baseline questionnaires. The participant also has the option to nominate someone who also knows their child well (e.g. a co-parent, a family member or close friend) to participate in the study with them and to complete a small number of questionnaires. This will help to give us a broader, more objective picture of the child, but is an optional part of the study. 48 hours later (to allow time for the participants to contact the co-respondent if they choose) the index participant will be randomised to one of two groups: either the intervention (the online course), or the control group where they do not receive the intervention.
Those in the intervention will be randomised to receive 8 out of 9 modules of the course, with a suggested time frame of one or two modules a week, each module taking about 30 minutes, with some home-practice tasks in-between.
Both the intervention group and the control group participants will be contacted again after 6 months to complete a set of follow-up questionnaires (similar to those completed at baseline). Depending on when each participant joins the trial, they may be contacted a third time towards the end of the life of the study, to complete another set of questionnaires,9-21 months after their first.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Raising Confident Children CourseAn online learning tool, designed to helps parents develop a calm, consistent behaviour management style, whilst learning skills to discourage children's avoidance. |
| Control | No intervention | –The participants in the control arm will not receive access to the online course, but will complete the same sets of questionnaires at each of the timepoints. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Be a parent (any gender, adoptive/biological/step/foster/grandparent) aged 16+, of a child aged 2 to 11 years (inclusive). The index parent must have at least 50 days' contact with the index child per year and confirm that they see enough of the child to report on the child's current anxiety level.
- Index parent must be a UK resident.
- Self-report subjectively substantial levels of current or lifetime anxiety.
- Able to commit to completion of measures at (up to) three time points even if allocated to the control arm.
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| Raising Confident Children CourseAn online learning tool consisting of 8 different modular components, designed to reduce the transmission of anxiety from parents to children. The modular components include: a core starter about anxiety, the role of avoidance, using play to develop childrens confidence, using Emotion Coaching with children, managing difficult behaviour, the role of sleep, exercise and diet, reducing overprotection, modelling confident behaviour and managing difficult behaviour. | Behavioural | Intervention |
Primary outcome
Change in child anxiety
Time frame: Baseline, 6 months, and up to 21 months.
Measured using the Spence Children's Anxiety Scale (SCAS-P and Preschool SCAS if the child is aged 6 or under). SCAS-P: Minimum 0 Maximum 114. A higher total score is indicative of higher level of child anxiety. T scores used to indicate clinical levels of anxiety however this is a screen not a diagnostic instrument. SCAS Preschool: Minimum 0 Maximum 112. A higher total indicates a higher level of pre-school child anxiety. A score of 1SD above the mean for a subscale or the total score indicates clinical investigated would be warranted.
6 secondary outcomes
Change in parent anxiety and parental wellbeing
Time frame: Baseline, 6 months, and up to 21 months.
Change in parent anxiety and parental wellbeing
Time frame: Baseline, 6 months, and up to 21 months.
Change in child wellbeing and health
Time frame: Baseline, 6 months, and up to 21 months.
Change in child wellbeing and health
Time frame: Baseline, 6 months, and up to 21 months.
Change in anxiogenic parenting behaviours
Time frame: Baseline, 6 months, and up to 21 months
Change in anxiogenic parenting behaviours
Time frame: Baseline, 6 months, and up to 21 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
- Derived from this study: PubMed 39291249Dunn A, Alvarez J, Arbon A, Bremner S, Elsby-Pearson C, Emsley R, Jones C, Lawrence P, Lester KJ, Morson N, Simner J, Thomson A, Cartwright-Hatton S. Effectiveness of an unguided modular online intervention for highly anxious parents in preventing anxiety in their children: a parallel group randomised controlled trial. Lancet Reg Health Eur. 2024 Sep 4;45:101038. doi: 10.1016/j.lanepe.2024.101038. eCollection 2024 Oct.
- Derived from this study: PubMed 36355406Dunn A, Alvarez J, Arbon A, Bremner S, Elsby-Pearson C, Emsley R, Jones C, Lawrence P, Lester KJ, Majdandzic M, Morson N, Perry N, Simner J, Thomson A, Cartwright-Hatton S. Effectiveness of a Web-Based Intervention to Prevent Anxiety in the Children of Parents With Anxiety: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2022 Nov 10;11(11):e40707. doi: 10.2196/40707.
- Individual participant dataSharing planned: No. Data will not be shared on an individual basis. Anonymised study data will be archived at the end of the study through the University of Sussex data repository, Figshare.
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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.
Abby Dunn contact
Sam Cartright-Hatton principal investigator
University of Sussex
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Raising Confident Children Course in people with Child Anxiety and Parent Anxiety, run by University of Sussex at 1 site in United Kingdom.
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 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: status not confirmed, as of the sponsor's last update on 19 May 2022. 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 United Kingdom. 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?
Contact Amy Arbon (01273 641444, a.arbon@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in child anxiety (time frame: Baseline, 6 months, and up to 21 months.). 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 NCT04755933, which also lists 2 linked publications.
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 19 May 2022.