- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07826702
Nonviolent Communication Plus Personalised E-message for Parents
A Rolling Two-session Nonviolent Communication Intervention Plus Personalised E-message in Improving Child-parent Relationship: a Pilot Randomised Controlled Trial
This pilot randomised controlled trial (RCT) aims to evaluate the feasibility, acceptability, and preliminary effects of combining a brief Nonviolent Communication (NVC) intervention with follow-up personalised AI-generated messages delivered daily via WhatsApp to improve child-parent relationships, parenting competence and family communication.
A total of 60 parents of middle school students experiencing difficulties in family communication or recurrent conflict with their children will be recruited in Hong Kong and randomly assigned (in a 1:1 allocation ratio) to an intervention group or an attention control group.
The intervention group will participate in two 2-hour NVC workshops, scheduled two weeks apart and delivered by the principal investigator, plus four weeks of personalised AI-generated NVC e-messages daily. The attention control group will receive weekly e-messages with healthy lifestyle tips for 6 weeks.
Assessments for participants will be conducted at baseline (T0), post-workshop (T1, after the second session/two weeks after T0), and 12 weeks after baseline (T2). A process evaluation featuring quantitative ratings and open-ended questions will be conducted to explore participants' perceived benefits and subjective experiences.
Přehled studie
Postavení
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Yuying Sun, PhD
- Telefonní číslo: 852 39702916
- E-mail: gsun@hkmu.edu.hk
Studijní místa
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Hong Kong, Hongkong
- The Jockey Club Institute of Healthcare, Hong Kong Metropolitan University
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Kontakt:
- Yuying Sun, PhD
- Telefonní číslo: 852 39702916
- E-mail: gsun@hkmu.edu.hk
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- 1) parents aged 32-59 years with children attending middle school (approximately 12-17 years old) in Hong Kong;
- 2) scoring 3 or above in any item of the 3-item conflict subscale of the Network of Relationship Inventory (Furman & Buhrmester, 2009);
- 3) able to read Chinese and use a smartphone to receive WhatsApp messages;
- 4) willingness to attend a two-session NVC intervention in group format.
Exclusion Criteria:
- 1) severe mental health problems requiring immediate specialist care or inability to provide informed consent.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: NVC Intervention Group
Participants in the intervention group will receive two 2-hour NVC intervention workshops, scheduled two weeks apart and delivered in small groups (either online or face-to-face) by the PI, plus four weeks of daily personalised AI-generated NVC messages via WhatsApp.
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The intervention includes an introduction to NVC's four principles, the difference between observations and judgments, identifying and expressing feelings, taking responsibility for feelings and needs, and using positive action language when making requests. The intervention workshops will be offered in rolling monthly cycles for approximately three rounds over three months (two rounds will be online, and one will be face-to-face). Participants who miss the second session may attend an equivalent session in the second or third cycle. Between and following the sessions, participants will receive AI-generated, tailored messages via WhatsApp daily for four weeks that provide concise NVC tips and guide parents through NVC-style conversations with their adolescents. |
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Aktivní komparátor: Attention Control Group
Participants in the attention control group will not receive any NVC intervention workshops during the study.
They will receive regular healthy lifestyle information messages via WhatsApp for 6 weeks.
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The attention control group will receive an information pamphlet that encourages them to maintain a healthy diet, engage in regular physical activity, and practice weight control.
Participants will receive weekly WhatsApp messages about healthy lifestyle tips for 6 weeks.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Recruitment rate
Časové okno: Baseline (T0)
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Recruitment rate is defined as the proportion of eligible or contacted candidates who actually agree to join the study (Number Enrolled / Number Eligible or Approached).
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Baseline (T0)
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Retention rate
Časové okno: 12-week assessment (T2, around 3 months after baseline)
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Retention rate is defined as the percentage of randomised participants retained and assessed with valid primary outcome data.
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12-week assessment (T2, around 3 months after baseline)
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Child-Parent Relationship
Časové okno: Baseline (T0), Post-workshop assessment (T1, 2 weeks after T0), and 12-week assessment (T2, around 3 months after T0).
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The Child-Parent Relationship Scale (CPRS-SF) is a 15-item scale for evaluating two dimensions of the relationship between parents and children: conflict and closeness.
Items are rated on a 5-point Likert scale ranging from 1 ("strongly disagree") to 5 ("strongly agree").
Scores for closeness and conflict are calculated separately, with higher closeness scores indicating a stronger emotional bond and a supportive relationship between parents and children (Driscoll & Pianta, 2011).
Higher conflict scores indicate greater conflict between parents and children.
The internal consistency reliabilities were adequate in a Chinese sample (Cronbach's alpha = 0.78 to 0.81) (Tan et al., 2023).
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Baseline (T0), Post-workshop assessment (T1, 2 weeks after T0), and 12-week assessment (T2, around 3 months after T0).
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Parenting Competence
Časové okno: Baseline (T0), Post-workshop assessment (T1, 2 weeks after T0), and 12-week assessment (T2, around 3 months after T0).
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The Parenting Sense of Competence Scale (PSOC) (Ngai et al., 2007) is a 17-item scale to measure parents' perceived competence in the parenting role.
Each item is rated on a 6-point Likert scale ranging from 1 (strongly disagree) to 6 (strongly agree).
Higher scores indicate greater competence in parenting.
Cronbach's alpha was 0.93 in a Chinese sample.
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Baseline (T0), Post-workshop assessment (T1, 2 weeks after T0), and 12-week assessment (T2, around 3 months after T0).
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Family function
Časové okno: Baseline (T0), Post-workshop assessment (T1, 2 weeks after T0), and 12-week assessment (T2, around 3 months after T0).
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The Family Communication Scale (FCS) is a 10-item scale used to measure family communication (Guo et al., 2021).
Items are rated on a 5-point Likert scale, ranging from 1 ("strongly disagree") to 5 ("strongly agree").
A higher total score (range 10-50) indicates a higher level of positive family communication.
The Chinese version of FCS showed good internal consistency (Cronbach's alpha = 0.91) and was stable over 1 month (intraclass correlation coefficient = 0.69).
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Baseline (T0), Post-workshop assessment (T1, 2 weeks after T0), and 12-week assessment (T2, around 3 months after T0).
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Anxiety
Časové okno: Baseline (T0), Post-workshop assessment (T1, 2 weeks after T0), and 12-week assessment (T2, around 3 months after T0).
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The Generalized Anxiety Disorder (GAD)-7 scale is a 7-item instrument to assess anxiety symptoms in the past two weeks (Spitzer et al., 2006; Tong et al., 2016).
Each item is scored from 0 to 3. The seven item scores are summed to yield a total score ranging from 0 to 21, with higher scores indicating greater anxiety symptom severity.
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Baseline (T0), Post-workshop assessment (T1, 2 weeks after T0), and 12-week assessment (T2, around 3 months after T0).
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Perceived Benefits
Časové okno: Post-workshop assessment (T1) and 12-week assessment (T2, around 3 months after T0)
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Evaluated through process evaluation metrics assessing perceived benefits, subjective changes in personal mental health, and happiness.
Participants rate overall satisfaction on a 0-10 scale, with 0 indicating "very dissatisfied" and 10 indicating "very satisfied".
Open-ended questions will also collect participants' comments and suggestions.
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Post-workshop assessment (T1) and 12-week assessment (T2, around 3 months after T0)
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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Yuying Sun, PhD, Hong Kong Metropolitan University
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- RD/2026/1.24
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