Ignite Creation Date:
2024-10-25 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06588985
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-04
Brief Title:
Exploring the Role of Parental Emotion Regulation and Outcomes of Parental Emotional Coaching on Child and Adolescent Psychosocial Outcomes
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Exploring the Role of Parental Emotion Regulation and Outcomes of Parental Emotional Coaching on Child and Adolescent Psychosocial Outcomes
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Emotional regulation has been found to play a crucial role in an individuals mental well-being and emotional dysregulation is implicated in most of psychiatric disorders listed in the Diagnostic and Statistical Manual Fifth Edition DSM-5 APA 2013 Gross Levenson 1997 Thoits 1985 Specifically in children poor emotional regulation skills and parental emotional dysregulation contribute significantly to childhood psychopathology Han Shaffer 2014 This study has two parts - Part 1 aims to explore and identify the parental emotion socialization factors that contributes to a childs emotion regulation abilities and examine how parental emotion dysregulation contribute to the profile of a childs emotional and behavioral difficulties Part 2 attempts to determine the effectiveness of parental emotional coaching in developing a childs emotion regulation abilities and reducing a childs symptoms of psychopathology Participants will include both nonclinical and clinical samples consisting of children and adolescents aged 7 to 17 years old middle childhood to adolescence and their parents Participants will be invited to complete a set of questionnaires Part 1 and to participate in a randomized controlled trial that provides parents with a workshop on emotion coaching skills Part 2 Data will be analysed using correlationregression analyses and mixed Analysis of Variance ANOVA Clinical implications from this study includes informing of improvements to the clinical services provided in the healthcare setting as well as contribute to the transdiagnostic formulation of children and adolescent mental health conditions
Detailed Description:
Proposed Methodology This research proposes 2 studies to investigate the above stated questions Study 1 will utilize a cross-sectional design with children and adolescents as well as their parents from general population completing questionnaires provided while Study 2 will involve inviting participants from Study 1 to participate in a randomized controlled trial Participants may choose to only participate in Study 1 and not Study 2 If participants are keen and provide consent to participate in Study 2 they will have to complete both interventions and all questionnaires required at all timepoints
Participants Procedure Participants include children and adolescents aged 7 to 17 years old and one of their parents Participants will be recruited from the community and the Student Health Centre at Health Promotion Board HPB HPB is only used as a referral site and recruitment site Research procedures are not conducted on their premise Both parents and children will be required to be fluent in the English language and all parent-child dyads will be invited to participate
In terms of procedure interested participants parent-child dyads will be invited to participate Consent will be collected from the child and their parents For Study 1 after consent is taken participants will be asked to complete a set of questionnaires and indicate their interest to participate in Study 2 Survey questionnaires will be administered either face-to-face or online - for face-to-face administration the researcher will provide parent-child dyad with a tablet to complete the questionnaires for online administration parent-child dyads will be emailed a link to the questionnaires to complete most likely on Qualtrics All participants are advised to complete all questions and do not skip A copy of the questionnaire will be shown in its entirety to participants before providing consent For children if they have difficulty understanding the questions they are allowed to skip it or seek help from their parentsresearcher The parents questionnaire should take at most 30 minutes to complete while the childs questionnaire will take at most 15 minutes to complete
If participants only participate in Study 1 they will only be required to complete the set of questionnaires at Timepoint 1 Participants in Study 1 will not be debriefed but they can request to be debriefed by contacting the research team and we can arrange a debrief via Zoom
In Study 2 a randomized controlled trial is designed to test the effects of parent emotion coaching on parental factors such as ER skills sense of competency and mood and stress levels child factors such as ER skills internalizing and externalizing problems and treatment outcomes as well as parent-child relationship Participants will be a subset of Study 1s participants
If participants indicate interest to participate in Study 2 the parents will be randomly assigned to the following experimental groups 1 Emotion Coaching Training or 2 Waitlist Control condition Parents in the emotion coaching workshop will be invited to attend an online training on emotion coaching strategies while parents in the control condition will not be receiving any training workshops during the study They will be invited to join the online workshops when the study is completed Participants will not be informed of the group that they are assigned to and a debrief session will be provided once they complete the study
The training module consists of a three-hour workshop followed by 2 bi-weekly 30-minute phoneonline consultations participants can choose from preferred timeslot on weekdays during regular work hours
Parents and children will be required to complete the set of outcome measures at pre- post-treatment and at a 1-month follow-up All procedures are conducted in English only
Estimated timeline for the different groups
Treatment Group - Week 0 Questionnaire parent and child Weeks 1 - 5 Parent Workshop 2 phone consults Week 6 post-questionnaire parent and child Week 9 - 10 follow-up questionnaire parent and child Intervention phase itself will last at most 5 weeks The 3-hour online workshop will be conducted in real-time over Zoom by a clinical psychologist or a Masters in Clinical Psychologist student supervised by a clinical psychologist
Waitlist Group - Week 0 Questionnaire parent and child Week 6 Questionnaire T2 parent and child Week 9-10 Questionnaire T3 parent and child After they have completed all 3 sets of questionnaires they will be invited to sign up for the workshop on dates that are convenient for them The 3-hour online workshop will be conducted in real-time over Zoom by a clinical psychologist or a Masters in Clinical Psychologist student supervised by a clinical psychologist
At the end of Study 2 all participants will be provided with the debrief sheet either hard or soft copy can be provided and offered a debrief session over Zoom The debrief session will be conducted by the research team
In cases whereby participants may wish to have longer consultation sessions or to extend the intervention outside of the research they may be referred to the relevant professionalsservices
Participants have until 1 week after they completed the study to decide if they wish to withdraw their research data
Participants Procedure Participants include children and adolescents aged 7 to 17 years old and one of their parents Participants will be recruited from the community and the Student Health Centre at Health Promotion Board HPB HPB is only used as a referral site and recruitment site Research procedures are not conducted on their premise Both parents and children will be required to be fluent in the English language and all parent-child dyads will be invited to participate
In terms of procedure interested participants parent-child dyads will be invited to participate Consent will be collected from the child and their parents For Study 1 after consent is taken participants will be asked to complete a set of questionnaires and indicate their interest to participate in Study 2 Survey questionnaires will be administered either face-to-face or online - for face-to-face administration the researcher will provide parent-child dyad with a tablet to complete the questionnaires for online administration parent-child dyads will be emailed a link to the questionnaires to complete most likely on Qualtrics All participants are advised to complete all questions and do not skip A copy of the questionnaire will be shown in its entirety to participants before providing consent For children if they have difficulty understanding the questions they are allowed to skip it or seek help from their parentsresearcher The parents questionnaire should take at most 30 minutes to complete while the childs questionnaire will take at most 15 minutes to complete
If participants only participate in Study 1 they will only be required to complete the set of questionnaires at Timepoint 1 Participants in Study 1 will not be debriefed but they can request to be debriefed by contacting the research team and we can arrange a debrief via Zoom
In Study 2 a randomized controlled trial is designed to test the effects of parent emotion coaching on parental factors such as ER skills sense of competency and mood and stress levels child factors such as ER skills internalizing and externalizing problems and treatment outcomes as well as parent-child relationship Participants will be a subset of Study 1s participants
If participants indicate interest to participate in Study 2 the parents will be randomly assigned to the following experimental groups 1 Emotion Coaching Training or 2 Waitlist Control condition Parents in the emotion coaching workshop will be invited to attend an online training on emotion coaching strategies while parents in the control condition will not be receiving any training workshops during the study They will be invited to join the online workshops when the study is completed Participants will not be informed of the group that they are assigned to and a debrief session will be provided once they complete the study
The training module consists of a three-hour workshop followed by 2 bi-weekly 30-minute phoneonline consultations participants can choose from preferred timeslot on weekdays during regular work hours
Parents and children will be required to complete the set of outcome measures at pre- post-treatment and at a 1-month follow-up All procedures are conducted in English only
Estimated timeline for the different groups
Treatment Group - Week 0 Questionnaire parent and child Weeks 1 - 5 Parent Workshop 2 phone consults Week 6 post-questionnaire parent and child Week 9 - 10 follow-up questionnaire parent and child Intervention phase itself will last at most 5 weeks The 3-hour online workshop will be conducted in real-time over Zoom by a clinical psychologist or a Masters in Clinical Psychologist student supervised by a clinical psychologist
Waitlist Group - Week 0 Questionnaire parent and child Week 6 Questionnaire T2 parent and child Week 9-10 Questionnaire T3 parent and child After they have completed all 3 sets of questionnaires they will be invited to sign up for the workshop on dates that are convenient for them The 3-hour online workshop will be conducted in real-time over Zoom by a clinical psychologist or a Masters in Clinical Psychologist student supervised by a clinical psychologist
At the end of Study 2 all participants will be provided with the debrief sheet either hard or soft copy can be provided and offered a debrief session over Zoom The debrief session will be conducted by the research team
In cases whereby participants may wish to have longer consultation sessions or to extend the intervention outside of the research they may be referred to the relevant professionalsservices
Participants have until 1 week after they completed the study to decide if they wish to withdraw their research data
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None