Clinical trial NCT06588985: Exploring the Role of Parental Emotion Regulation and Outcomes of Parental Emotional Coaching on Child and Adolescent Psychosocial Outcomes
Official title: Exploring the Role of Parental Emotion Regulation and Outcomes of Parental Emotional Coaching on Child and Adolescent Psychosocial Outcomes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Emotion Regulation
Keywords: Emotion Coaching
Lead sponsor: National University of Singapore
Sponsor class: OTHER
Collaborators: name: Ministry of Education, Singapore
First posted: 2024-09-19
Enrollment: 200
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to either the treatment group or waitlist control group.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Emotional regulation has been found to play a crucial role in an individual's 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 child's emotion regulation abilities and examine how parental emotion dysregulation contribute to the profile of a child's emotional and behavioral difficulties; Part 2 attempts to determine the effectiveness of parental emotional coaching in developing a child's emotion regulation abilities and reducing a child's 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 correlation,regression 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 parents/researcher. The parents' questionnaire should take at most 30 minutes to complete, while the child's 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 1's 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 phone/online 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 professionals/services.

Participants have until 1 week after they completed the study to decide if they wish to withdraw their research data.

Eligibility criteria: Inclusion Criteria:

* Participants include children and adolescents aged 7 to 17 years old, and one of their parents.
* All parent-child dyads will be invited to participate.
* Parents and children have to be fluent in English.
* Persons who are not parents will not be recruited.

Exclusion Criteria:

* Children or parents with physical impairments (apart from corrected vision) will be excluded.
* Children or parents reporting psychotic symptoms, neurodevelopmental disorders, or severe mood disorders will be excluded.

Primary outcomes:
measure: Emotion Regulation Questionnaire (ERQ; Gross & John, 2003)
timeFrame: Baseline, 1-month after baseline and at least 2-months after baseline
measure: Emotion Regulation Questionnaire for Children and Adolescents (ERQ-CA; Gullone & Taffe, 2011)
timeFrame: Baseline, 1-month after baseline and at least 2-months after baseline
measure: Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004)
timeFrame: Baseline, 1-month after baseline and at least 2-months after baseline
Secondary outcomes:
measure: Depression Anxiety Stress Scales short version (DASS-21; Lovibond & Lovibond, 1995)
timeFrame: Baseline, 1-month after baseline and at least 2-months after baseline
measure: Parent Sense of Competency (PSOC; Gilmore & Cuskelly, 2008)
timeFrame: Baseline, 1-month after baseline and at least 2-months after baseline
measure: Parent Relationship Questionnaire (PRQ; Kamphaus & Reynolds, 2006)
timeFrame: Baseline, 1-month after baseline and at least 2-months after baseline
measure: Security Scale questionnaire (SSQ; Kerns et al., 1996)
timeFrame: BBaseline, 1-month after baseline and at least 2-months after baseline
measure: Big-Five Questionnaire for Children (BFQ-C; Barbaranelli et al., 2003)
timeFrame: Baseline only
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University of Singapore
Study officials:
affiliation: National University of Singapore
name: Jamie Ong
role: PRINCIPAL_INVESTIGATOR
References: