Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:34 AM
Study NCT ID:
NCT05371002
Status:
SUSPENDED
Last Update Posted:
2023-11-30
First Post:
2022-05-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of Online Group-based Nonviolent Communication Interventions
Sponsor:
The University of Hong Kong
Organization:
Study Overview
Official Title:
Effectiveness of Online Group-based Nonviolent Communication Interventions for Reducing Parenting Stress in Parents With Mild to Moderate Depressive Symptoms: a Randomized Controlled Trial
Status:
SUSPENDED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to lack of funding source, the main trial has been suspended. The research team is looking for funding source to recover the trial.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a randomized controlled trial (RCT) to test the effectiveness of nonviolent communication (NVC) intervention for reducing parenting stress to parents with children in primary schools and mild to moderate depression. A pilot RCT on 50 participants (25 in NVC vs. 25 in control group, 2 small groups for each arm) will be conducted in late June to September 2022 to test the procedure and preliminary results. A RCT (1:1 allocation ratio) on 200 parents who have children of Grade 1-6 and mild to moderate depressive symptoms assessed by Patient Health Questionnaire (PHQ)-9. Outcomes will be measured at baseline, immediately after completion of intervention and three months after the intervention. This study will provide evidence on the effectiveness of NVC to reduce parenting stress and enhance parents' mental well-being.
Detailed Description:
Objectives: To test the effectiveness of nonviolent communication (NVC) intervention for reducing parenting stress in parents with mild to moderate depression and children in primary schools.
Hypothesis: Our intervention group will show more improvements in parents' NVC skills, parenting stress, depression and anxiety symptoms, and well-being than the control group.
Design and subjects: An RCT (1:1 allocation ratio) on 200 parents who have mild to moderate depressive symptoms assessed by Patient Health Questionnaire (PHQ)-9 and children of Grade 1-6.
Instruments: Parental Stress Scale; self-developed NVC scale; PHQ-9; Generalized Anxiety Disorder-7; Short Warwick-Edinburgh Mental Well-being Scale.
Interventions: Six 1.5-hour weekly online group sessions (10-14 participants in each group) will be delivered by NVC professionals to the intervention group, including (1) introduction to four key principles of NVC, communication that blocks compassion, and distinguishing observations from evaluations, (2) identifying and expressing feelings, providing a list of words to express feelings and four steps to express anger, (3) taking responsibility for feelings (needs), distinguishing between an outside event and the met or unmet needs behind the feelings, (4) using positive action language to make requests, (5) review and summary, and (6) experience sharing and suggestions for further practice. Group discussion will be used to sustain the participants' engagement. The waitlist control group will receive simple messages through the same media on physical activity and will be provided with the training sessions afterwards. A pilot study on 50 participants (25 in NVC vs. 25 in control group, 2 small groups for each arm) will be conducted in late June to September 2022 to test the procedure and preliminary results. Only T1 and T2 will be conducted to obtain the immediate effect of the intervention.
Outcome measures: Outcomes will be measured at baseline, immediately after completion of intervention and three months after the intervention. The primary outcome is parenting stress at 3-month after the intervention. Secondary outcomes include NVC skills, parental depression and anxiety symptoms, and well-being at 3-month after the intervention. Process evaluation will be conducted after the intervention. In-depth interviews will be conducted on 30 parents in the intervention group to explore participants' experiences.
Data analysis: Intention-to-treat approach. A multilevel mixed model will be used to evaluate the between-group mean differences in the outcomes of the two groups, after adjusting for baseline outcomes and demographics. Per-protocol sensitivity analyses will be conducted by only including the adherent participants who complete at least four sessions and all assessments. Mediation analysis will be conducted following AGReMA guideline. Cost analysis will be conducted.
Expected results: The intervention group will show greater improvements in the measured outcomes than the control group, offering strong evidence of effectiveness.
Hypothesis: Our intervention group will show more improvements in parents' NVC skills, parenting stress, depression and anxiety symptoms, and well-being than the control group.
Design and subjects: An RCT (1:1 allocation ratio) on 200 parents who have mild to moderate depressive symptoms assessed by Patient Health Questionnaire (PHQ)-9 and children of Grade 1-6.
Instruments: Parental Stress Scale; self-developed NVC scale; PHQ-9; Generalized Anxiety Disorder-7; Short Warwick-Edinburgh Mental Well-being Scale.
Interventions: Six 1.5-hour weekly online group sessions (10-14 participants in each group) will be delivered by NVC professionals to the intervention group, including (1) introduction to four key principles of NVC, communication that blocks compassion, and distinguishing observations from evaluations, (2) identifying and expressing feelings, providing a list of words to express feelings and four steps to express anger, (3) taking responsibility for feelings (needs), distinguishing between an outside event and the met or unmet needs behind the feelings, (4) using positive action language to make requests, (5) review and summary, and (6) experience sharing and suggestions for further practice. Group discussion will be used to sustain the participants' engagement. The waitlist control group will receive simple messages through the same media on physical activity and will be provided with the training sessions afterwards. A pilot study on 50 participants (25 in NVC vs. 25 in control group, 2 small groups for each arm) will be conducted in late June to September 2022 to test the procedure and preliminary results. Only T1 and T2 will be conducted to obtain the immediate effect of the intervention.
Outcome measures: Outcomes will be measured at baseline, immediately after completion of intervention and three months after the intervention. The primary outcome is parenting stress at 3-month after the intervention. Secondary outcomes include NVC skills, parental depression and anxiety symptoms, and well-being at 3-month after the intervention. Process evaluation will be conducted after the intervention. In-depth interviews will be conducted on 30 parents in the intervention group to explore participants' experiences.
Data analysis: Intention-to-treat approach. A multilevel mixed model will be used to evaluate the between-group mean differences in the outcomes of the two groups, after adjusting for baseline outcomes and demographics. Per-protocol sensitivity analyses will be conducted by only including the adherent participants who complete at least four sessions and all assessments. Mediation analysis will be conducted following AGReMA guideline. Cost analysis will be conducted.
Expected results: The intervention group will show greater improvements in the measured outcomes than the control group, offering strong evidence of effectiveness.
Study Oversight
Has Oversight DMC:
False
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?: