Mild to Moderate Depressive SymptomsNCT05371002
Effectiveness of Online Group-based Nonviolent Communication Interventions
A study testing Online group nonviolent communication (NVC) interventions in people with Mild to Moderate Depressive Symptoms, run by The University of Hong Kong at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 24 to 59 years
- Conditions the study is for
- Mild to Moderate Depressive Symptoms
- What is being tested?
- Online group nonviolent communication (NVC) interventions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteChina
- Study dates
- 16 May 2022to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
School of Nursing and Health Studies, Hong Kong Metropolitan University
Hong Kong
About this study
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
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.
Read the 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.
- Conditions
- Mild to Moderate Depressive Symptoms
- Being tested
- Online group nonviolent communication (NVC) interventions, Waitlist control group
- Keywords
- depression, parents
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online group nonviolent communication (NVC) interventionsBehavioural
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.
Waitlist control groupOther
Waitlist control, but included a short active intervention during the 2nd and 3rd assessments.
| Study group | Role | What they receive |
|---|---|---|
| Online group nonviolent communication (NVC) interventions | Experimental | 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. Receives: Behavioral: Online group nonviolent communication (NVC) interventions |
| Waitlist control group | Active comparator | 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). Receives: Other: Waitlist control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: T1: baseline; T2: immediate post-intervention; T3: 3-month after the intervention
Secondary outcomes (4)
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.
Measured: T1: baseline; T2: immediate post-intervention; T3: 3-month after the intervention
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.
Measured: T1: baseline; T2: immediate post-intervention; T3: 3-month after the intervention
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.
Measured: T1: baseline; T2: immediate post-intervention; T3: 3-month after the intervention
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.
Measured: T1: baseline; T2: immediate post-intervention; T3: 3-month after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start16 May 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Apr 2025 (estimated)
Why it stopped: Due to lack of funding source, the main trial has been suspended. The research team is looking for funding source to recover the trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild to Moderate Depressive SymptomsStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuying Sun, The University of Hong Kong
- Investigators
- Yuying Sun, PhD, Principal investigator, School of Public Health, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05371002
- Sponsor's protocol ID
- 17605422
- Status last verified
- Nov 2023
- First submitted
- 3 May 2022
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05371002
- Acronym / sponsor ID
- 17605422
- Conditions
- Mild to Moderate Depressive Symptoms
- Keywords
- depression, parents
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Due to lack of funding source, the main trial has been suspended. The research team is looking for funding source to recover the trial.
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 16 May 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 12 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Online group nonviolent communication (NVC) interventions | Experimental | Behavioral: Online group nonviolent communication (NVC) interventionsRosenberg'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. |
| Waitlist control group | Active comparator | Other: Waitlist control groupThe 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). |
Who may qualify
- Ages
- 24 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online group nonviolent communication (NVC) interventionsThe 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. | Behavioural | Online group nonviolent communication (NVC) interventions |
| Waitlist control groupWaitlist control, but included a short active intervention during the 2nd and 3rd assessments. | Other | Waitlist control group |
Primary outcome
Changes in parenting stress
Time frame: T1: baseline; T2: immediate post-intervention; T3: 3-month after the intervention
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.
4 secondary outcomes
Changes in NVC skills
Time frame: T1: baseline; T2: immediate post-intervention; T3: 3-month after the intervention
Changes in depressive symptoms
Time frame: T1: baseline; T2: immediate post-intervention; T3: 3-month after the intervention
Changes in anxiety symptoms
Time frame: T1: baseline; T2: immediate post-intervention; T3: 3-month after the intervention
Changes in well-being
Time frame: T1: baseline; T2: immediate post-intervention; T3: 3-month after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
Related trials for Mild to Moderate Depressive Symptoms
Active, not recruiting
A Pilot Study of Synbiotics in Adults With Depressive Symptoms
Depressive Symptoms Mild to Moderate in Severity
Recruiting
Neuroscience of Psychotherapy for Depression
Depression
Not yet recruiting
Probiotics for Depressive Symptomatology and Neural Activity.
Mild-to-moderate Depression, Neural Activity
Not yet recruiting
PB-18 Probiotic for Mild to Moderate Depression
Depressive Disorder
Not yet recruiting
Online Self-healing Program
Mild to Moderate Depressive Symptoms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuying Sun, PhD principal investigator
School of Public Health, The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online group nonviolent communication (NVC) interventions in people with Mild to Moderate Depressive Symptoms, run by The University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in parenting stress (time frame: T1: baseline; T2: immediate post-intervention; T3: 3-month after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2023.