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Effectiveness of Online Group-based Nonviolent Communication Interventions

Primary Purpose

Mild to Moderate Depressive Symptoms

Status
Suspended
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Online group nonviolent communication (NVC) interventions
Waitlist control group
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Mild to Moderate Depressive Symptoms focused on measuring depression, parents

Eligibility Criteria

24 Years - 59 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Parents with children in primary schools (Grade 1-6, age 6-12), aged 24-59 years;
  • With mild to moderate depressive symptoms (score of 5-14 on the PHQ-9);
  • Hong Kong residents who can communicate in Chinese (Cantonese or Mandarin).

Exclusion Criteria:

  • Have been diagnosed as major depressive disorder in the past 6 months;
  • Under psychiatric treatment;
  • Currently participating in other parenting or related programs;
  • Parents with PHQ score > 14 will be advised to consult a doctor.

Sites / Locations

  • School of Public Health, The University of Hong Kong

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Online group nonviolent communication (NVC) interventions

Waitlist control group

Arm Description

Rosenberg's "Nonviolent Communication: A Language of Life: Life-changing Tools for Healthy Relationships" and "Raising Children Compassionately: Parenting the Nonviolent Communication Way" will be used as reference guides. 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 participants in WL group will not be provided any materials or training content between baseline (T1) and immediate post assessment (T2). Once the participants completed the T2 assessments, they will be delivered one 1.5-hour online session about physical activity (completely different from NVC training content). In the session, the participants will be introduced the concept of Zero-time exercise and provided video demonstrations of exercise. Six 1.5-hour weekly NVC training sessions (the same as those in intervention group) will be delivered to participants as soon as they have completed the final assessment at T3 (three months after T2).

Outcomes

Primary Outcome Measures

Changes in parenting stress
Parenting stress will be assessed by Parental Stress Scale (PSS). An 16-item PSS has been developed by Leung et al for Hong Kong Chinese parents. It assesses the parenting stress using a 5-point response scale, ranging from 18 to 80.

Secondary Outcome Measures

Changes in NVC skills
A Chinese version will be developed based on the four core components of NVC, with each item rated on a 5-point scale ranging from 0 = never to 5 = always. The average score will be calculated, with higher scores indicating better NVC skills.
Changes in depressive symptoms
The Patient Health Questionnaire (PHQ)-9 will be used to measure depressive symptoms. Participants rate the frequency of nine symptoms over the past two weeks on a 4-point Likert scale (from 0=not at all to 3=nearly every day). The total score ranges from 0 to 27, with higher scores indicating a greater severity of depressive symptoms.
Changes in anxiety symptoms
Generalized Anxiety Disorder (GAD)-7 will be used to assess generalized anxiety disorder. Participants rate the frequency of seven symptoms over the past two weeks on a 4-point Likert scale (from 0=not at all to 3=nearly every day). The total score ranges from 0 to 21, with a higher score indicating a higher level of anxiety.
Changes in well-being
The 7-item Short Warwick-Edinburgh Mental Well-being Scale with the 5-point Likert scale (1 = none of the time, 5 = all the time) will be used. The score is calculated by summing all seven items with a range of 7 to 35. A higher score indicated higher level of wellbeing.

Full Information

First Posted
May 3, 2022
Last Updated
November 1, 2022
Sponsor
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT05371002
Brief Title
Effectiveness of Online Group-based Nonviolent Communication Interventions
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Suspended
Why Stopped
A pilot study on 44 participants was conducted in July to September 2022 to test the preliminary effectiveness. However, due to lack of funding source, the main trial has been suspended. We will keep looking for other funding sources.
Study Start Date
May 16, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild to Moderate Depressive Symptoms
Keywords
depression, parents

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A parallel individual RCT with two groups: (1) an intervention group receiving online group based NVC training and (2) a waitlist control (WL) group.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Online group nonviolent communication (NVC) interventions
Arm Type
Experimental
Arm Description
Rosenberg's "Nonviolent Communication: A Language of Life: Life-changing Tools for Healthy Relationships" and "Raising Children Compassionately: Parenting the Nonviolent Communication Way" will be used as reference guides. 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.
Arm Title
Waitlist control group
Arm Type
Active Comparator
Arm Description
The participants in WL group will not be provided any materials or training content between baseline (T1) and immediate post assessment (T2). Once the participants completed the T2 assessments, they will be delivered one 1.5-hour online session about physical activity (completely different from NVC training content). In the session, the participants will be introduced the concept of Zero-time exercise and provided video demonstrations of exercise. Six 1.5-hour weekly NVC training sessions (the same as those in intervention group) will be delivered to participants as soon as they have completed the final assessment at T3 (three months after T2).
Intervention Type
Behavioral
Intervention Name(s)
Online group nonviolent communication (NVC) interventions
Intervention Description
The primary purpose of NVC as defined by Dr. Marshall Rosenberg is to resolve interpersonal conflict using empathic communication skills. Nonviolence does not refer to the mere absence of physical harm. It is a way of life that helps us to transform old patterns of defensiveness and aggressiveness into compassion and empathy and to improve the quality of all types of relationships. The basic model of NVC consists of four key principles: the separation of observation from evaluation (observation), exploring and expressing the feelings that emerge from observations (feeling), taking responsibility for one's feelings (need), and telling others the need to enrich lives (request). A book on NVC specifically targets parents to improve communication and connection with their children. The NVC model emphasizes the importance of observation and has similarities with the concept of "mindful parenting", which refers to a non-judgmental and open parenting style.
Intervention Type
Other
Intervention Name(s)
Waitlist control group
Intervention Description
Waitlist control, but included a short active intervention during the 2nd and 3rd assessments.
Primary Outcome Measure Information:
Title
Changes in parenting stress
Description
Parenting stress will be assessed by Parental Stress Scale (PSS). An 16-item PSS has been developed by Leung et al for Hong Kong Chinese parents. It assesses the parenting stress using a 5-point response scale, ranging from 18 to 80.
Time Frame
T1: baseline; T2: immediate post-intervention; T3: 3-month after the intervention
Secondary Outcome Measure Information:
Title
Changes in NVC skills
Description
A Chinese version will be developed based on the four core components of NVC, with each item rated on a 5-point scale ranging from 0 = never to 5 = always. The average score will be calculated, with higher scores indicating better NVC skills.
Time Frame
T1: baseline; T2: immediate post-intervention; T3: 3-month after the intervention
Title
Changes in depressive symptoms
Description
The Patient Health Questionnaire (PHQ)-9 will be used to measure depressive symptoms. Participants rate the frequency of nine symptoms over the past two weeks on a 4-point Likert scale (from 0=not at all to 3=nearly every day). The total score ranges from 0 to 27, with higher scores indicating a greater severity of depressive symptoms.
Time Frame
T1: baseline; T2: immediate post-intervention; T3: 3-month after the intervention
Title
Changes in anxiety symptoms
Description
Generalized Anxiety Disorder (GAD)-7 will be used to assess generalized anxiety disorder. Participants rate the frequency of seven symptoms over the past two weeks on a 4-point Likert scale (from 0=not at all to 3=nearly every day). The total score ranges from 0 to 21, with a higher score indicating a higher level of anxiety.
Time Frame
T1: baseline; T2: immediate post-intervention; T3: 3-month after the intervention
Title
Changes in well-being
Description
The 7-item Short Warwick-Edinburgh Mental Well-being Scale with the 5-point Likert scale (1 = none of the time, 5 = all the time) will be used. The score is calculated by summing all seven items with a range of 7 to 35. A higher score indicated higher level of wellbeing.
Time Frame
T1: baseline; T2: immediate post-intervention; T3: 3-month after the intervention
Other Pre-specified Outcome Measures:
Title
Subjective changes in personal mental health
Description
The subjective changes in personal mental health compared with baseline will be rated on 5-point Likert scale, with "5" indicating "much better", "3" indicated "no change" and "1" indicated "much worse".
Time Frame
T2: immediate post-intervention; T3: 3-month after the intervention
Title
Subjective changes in parent-child conflict
Description
The subjective changes in parent-child conflict compared with baseline will be rated on 5-point Likert scale, with "5" indicating "much better", "3" indicated "no change" and "1" indicated "much worse".
Time Frame
T2: immediate post-intervention; T3: 3-month after the intervention
Title
Subjective changes in parent-child communication
Description
The subjective changes in parent-child communication compared with baseline will be rated on 5-point Likert scale, with "5" indicating "much better", "3" indicated "no change" and "1" indicated "much worse".
Time Frame
T2: immediate post-intervention; T3: 3-month after the intervention
Title
The overall satisfaction with the NVC courses
Description
The overall satisfaction with the NVC courses will be rated on a 0-10 scale by the participants, with "0" indicating "very unsatisfied" and "10" indicating "very satisfied".
Time Frame
T2: immediate post-intervention; T3: 3-month after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
24 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Parents with children in primary schools (Grade 1-6, age 6-12), aged 24-59 years; With mild to moderate depressive symptoms (score of 5-14 on the PHQ-9); Hong Kong residents who can communicate in Chinese (Cantonese or Mandarin). Exclusion Criteria: Have been diagnosed as major depressive disorder in the past 6 months; Under psychiatric treatment; Currently participating in other parenting or related programs; Parents with PHQ score > 14 will be advised to consult a doctor.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuying Sun, PhD
Organizational Affiliation
School of Public Health, The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Public Health, The University of Hong Kong
City
Hong Kong
Country
China

12. IPD Sharing Statement

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Effectiveness of Online Group-based Nonviolent Communication Interventions

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