Parenting With Anxiety: Helping Anxious Parents Raise Confident Children (PWA)
Primary Purpose
Child Anxiety, Parent Anxiety, Parental Wellbeing
Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Raising Confident Children Course
Sponsored by
About this trial
This is an interventional prevention trial for Child Anxiety focused on measuring Parenting
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- N/A
Sites / Locations
- University of SussexRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
An online learning tool, designed to helps parents develop a calm, consistent behaviour management style, whilst learning skills to discourage children's avoidance.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Change in child wellbeing and health
Measured using EQ-5D-Y Proxy. Minimum 11111 Maximum 33333. A higher score indicates a worse health status.
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).
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.
Full Information
NCT ID
NCT04755933
First Posted
February 2, 2021
Last Updated
May 18, 2022
Sponsor
University of Sussex
Collaborators
Kavli Trust, Brighton & Sussex Medical School
1. Study Identification
Unique Protocol Identification Number
NCT04755933
Brief Title
Parenting With Anxiety: Helping Anxious Parents Raise Confident Children
Acronym
PWA
Official Title
A Randomised Controlled Trial of an Online Intervention to Prevent Anxiety in the Children of Anxious Parents
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2021 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
April 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sussex
Collaborators
Kavli Trust, Brighton & Sussex Medical School
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Child Anxiety, Parent Anxiety, Parental Wellbeing, Child Wellbeing
Keywords
Parenting
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3508 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
An online learning tool, designed to helps parents develop a calm, consistent behaviour management style, whilst learning skills to discourage children's avoidance.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Raising Confident Children Course
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in child anxiety
Description
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.
Time Frame
Baseline, 6 months, and up to 21 months.
Secondary Outcome Measure Information:
Title
Change in parent anxiety and parental wellbeing
Description
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.
Time Frame
Baseline, 6 months, and up to 21 months.
Title
Change in parent anxiety and parental wellbeing
Description
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.
Time Frame
Baseline, 6 months, and up to 21 months.
Title
Change in child wellbeing and health
Description
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.
Time Frame
Baseline, 6 months, and up to 21 months.
Title
Change in child wellbeing and health
Description
Measured using EQ-5D-Y Proxy. Minimum 11111 Maximum 33333. A higher score indicates a worse health status.
Time Frame
Baseline, 6 months, and up to 21 months.
Title
Change in anxiogenic parenting behaviours
Description
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).
Time Frame
Baseline, 6 months, and up to 21 months
Title
Change in anxiogenic parenting behaviours
Description
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.
Time Frame
Baseline, 6 months, and up to 21 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
N/A
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amy Arbon
Phone
01273 641444
Email
a.arbon@nhs.net
First Name & Middle Initial & Last Name or Official Title & Degree
Abby Dunn
Email
abby.dunn@sussex.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sam Cartright-Hatton
Organizational Affiliation
University of Sussex
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Sussex
City
Brighton
ZIP/Postal Code
BN1 9RH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Arbon
Email
a.arbon@nhs.net
First Name & Middle Initial & Last Name & Degree
Abby Dunn
Email
abby.dunn@sussex.ac.uk
First Name & Middle Initial & Last Name & Degree
Sam Cartwright-Hatton
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
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.
Citations:
PubMed Identifier
36355406
Citation
Dunn 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.
Results Reference
derived
Learn more about this trial
Parenting With Anxiety: Helping Anxious Parents Raise Confident Children
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