NCT05371002

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 12, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

May 16, 2022

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

November 30, 2023

Status Verified

November 1, 2023

Enrollment Period

2.6 years

First QC Date

May 3, 2022

Last Update Submit

November 27, 2023

Conditions

Keywords

depressionparents

Outcome Measures

Primary Outcomes (1)

  • 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.

    T1: baseline; T2: immediate post-intervention; T3: 3-month after the intervention

Secondary Outcomes (4)

  • Changes in NVC skills

    T1: baseline; T2: immediate post-intervention; T3: 3-month after the intervention

  • Changes in depressive symptoms

    T1: baseline; T2: immediate post-intervention; T3: 3-month after the intervention

  • Changes in anxiety symptoms

    T1: baseline; T2: immediate post-intervention; T3: 3-month after the intervention

  • Changes in well-being

    T1: baseline; T2: immediate post-intervention; T3: 3-month after the intervention

Other Outcomes (4)

  • Subjective changes in personal mental health

    T2: immediate post-intervention; T3: 3-month after the intervention

  • Subjective changes in parent-child conflict

    T2: immediate post-intervention; T3: 3-month after the intervention

  • Subjective changes in parent-child communication

    T2: immediate post-intervention; T3: 3-month after the intervention

  • +1 more other outcomes

Study Arms (2)

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.

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).

Other: Waitlist control group

Interventions

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.

Online group nonviolent communication (NVC) interventions

Waitlist control, but included a short active intervention during the 2nd and 3rd assessments.

Waitlist control group

Eligibility Criteria

Age24 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Nursing and Health Studies, Hong Kong Metropolitan University

Hong Kong, China

Location

MeSH Terms

Conditions

Depression

Interventions

Methods

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Yuying Sun, PhD

    School of Public Health, The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: A parallel individual RCT with two groups: (1) an intervention group receiving online group based NVC training and (2) a waitlist control (WL) group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Professor

Study Record Dates

First Submitted

May 3, 2022

First Posted

May 12, 2022

Study Start

May 16, 2022

Primary Completion

December 31, 2024

Study Completion

April 30, 2025

Last Updated

November 30, 2023

Record last verified: 2023-11

Locations