Effectiveness of Online Group-based Nonviolent Communication Interventions for Reducing Parenting Stress in Parents With Mild to Moderate Depressive Symptoms: a Randomized Controlled Trial
Online group nonviolent communication (NVC) interventions
+ Waitlist control group
Estudio de Investigación en servicios de salud
Resumen
Fecha de inicio: 16 de mayo de 2022
Fecha en la que se inscribió al primer participante.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.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 250 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Investigación en Servicios de Salud
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.De 24 a 59 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Criterios
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.2 grupos de intervención están designados en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalGrupo II
Comparador ActivoObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
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School of Nursing and Health Studies, Hong Kong Metropolitan University
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