Ignite Creation Date:
2024-05-06 @ 3:47 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04755933
Status:
UNKNOWN
Last Update Posted:
2022-05-19
First Post:
2021-02-02
Brief Title:
Parenting With Anxiety Helping Anxious Parents Raise Confident Children
Sponsor:
University of Sussex
Organization:
University of Sussex
Study Overview
Official Title:
A Randomised Controlled Trial of an Online Intervention to Prevent Anxiety in the Children of Anxious Parents
Status:
UNKNOWN
Status Verified Date:
2022-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PWA
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 CI 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 childrens 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 eg 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 questionnaires9-21 months after their first
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 eg 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 questionnaires9-21 months after their first
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None