- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT04445818
More Appreciation and Less Criticism Project
A Pilot Intervention Study to Increase Appreciation and Reduce Criticism Among Families in Hong Kong
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
This study is a cluster randomized controlled trial (RCT) with three arms: More Appreciation (MA), Less Criticism and Fruit and Vegetable (FV) group. Clusters, mostly schools, are the unit of random allocation to one of the three arms. Participants from all three arms will be assessed a total of four times, i.e. baseline (before the intervention workshop; (T1), immediate post-workshop (T2), 2-week post-workshop (T3) and 6-week post-workshop (T4).
"Fruit and vegetable consumption" is a subsidiary study to the More Appreciation and Less Criticism (MALC) Project. The study will take advantage of the cluster RCT design adopted by the MALC study, and aims at testing the active HAPA-based intervention (increasing fruit and vegetable intervention) delivered to the MALC control group. The fruit and vegetable group will serve as the intervention arm, and the groups that received interventions regarding increasing appreciation or decreasing criticism, served as the control arms.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Parents who are Cantonese-speaking, able to complete study questionnaire, and who have children attending p.4 to p.6 will be included.
Exclusion Criteria:
- Parents with active psychiatric problems, suicidal ideations, personality disorders, emotional problems, and mental retardartion will be excluded from the study.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: More Appreciation
A 6-minute engaging video will be shown, illustrating examples where a mother initially withholds her appreciation for her son's effort in school and later express it.
The video will also capture the effect on the child and the family.
Attributional discussion questions will follow to elicit positive outcomes of expressing appreciation and the negative outcomes of withholding appreciation (e.g., What may be the long-term effects of showing appreciation on your child, family, or on yourself?).
Key points will be summarised and reinforced to enhance behavioural intention (Schwarzer & Luszczynska, 2008).
Then the participants will be asked to plan by indicating when (e.g., Saturday afternoon), what (e.g., child helping a younger sibling prepare for a dictation test), and how (e.g., "I can see that you gave up your leisure time to help your sister with the spelling.
Thank you!") they would express appreciation to their children.
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Sperimentale: Less Criticism
Participants will watch a 6-minute video showing examples of a father criticising his son, which will be replaced by positive communication later, and the different reactions evoked in the child and the family.
Then, participants will have an attributional discussion on the negative effects of criticism (e.g., negative effect on self-worth and motivation) and positive outcomes of using constructive feedback (e.g., promptly identifying undesirable behaviours without relating to personal traits or abilities).
In small groups, they will work out alternatives (i.e., constructive feedback; termed "positive reminder" in the intervention) to criticism, and each plan and write down when (e.g., after school), what (e.g., low test marks), and how (e.g., "How do you prepare for the tests?)
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Sperimentale: Fruit and Vegetable
This workshop will emphasise the importance of consuming at least 5 portions of fruit and vegetable daily for a healthy diet, and aim to boost participants' self-efficacy in achieving this.
Participants will be presented with examples of one portion of fruit or vegetable, and then create their own recipes.
They will also consider how to overcome obstacles of consuming more portions.
Each participant will set goals and write down plans on when, where, what, and how they would increase their fruit and vegetable intake of their children and family as a whole.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Changes from baseline self-reported appreciation behaviours at follow-ups
Lasso di tempo: Baseline (before the workshop, T1), 2-week post-workshop (T3) and 6-week post-workshop (T4).
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Being assessed by averaging two items, measuring the frequency with which parents expressed appreciation (express appreciation towards children's efforts; express appreciation towards children's strengths) in the past 7 days.
Responses range from 0 to 6 (0: '0 time,' 1: 'one to two times per week,' 2: 'three to four times per week,' 3: 'five to six times per week,' 4: 'once a day,' 5: 'two to three times a day,' and 6: 'four times or more per day').
The Cronbach's alpha is 0.90.
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Baseline (before the workshop, T1), 2-week post-workshop (T3) and 6-week post-workshop (T4).
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Changes from baseline self-reported criticism behaviours at follow-ups
Lasso di tempo: Baseline (before the workshop, T1), 2-week post-workshop (T3) and 6-week post-workshop (T4).
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Being assessed by averaging two items, measuring the frequency with which parents expressed criticism (criticise children; express dissatisfaction towards children's behavior) in the past 7 days.
Responses range from 0 to 6 (0: '0 time,' 1: 'one to two times per week,' 2: 'three to four times per week,' 3: 'five to six times per week,' 4: 'once a day,' 5: 'two to three times a day,' and 6: 'four times or more per day').
The Cronbach's alpha is 0.93.
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Baseline (before the workshop, T1), 2-week post-workshop (T3) and 6-week post-workshop (T4).
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Changes from baseline self-reported fruit and vegetable intake behaviours at follow-ups
Lasso di tempo: Baseline (before the workshop, T1), 2-week post-workshop (T3) and 6-week post-workshop (T4).
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Being assessed by summing two items, one each for the number of servings of fruits and vegetables consumed in the past week.
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Baseline (before the workshop, T1), 2-week post-workshop (T3) and 6-week post-workshop (T4).
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Changes from baseline outcome expectancies of more appreciation at post-workshop
Lasso di tempo: Baseline (before the workshop, T1), and T2 (immediately after the workshop).
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Measured by averaging three items, "If I express my appreciation through words or action more often, my children will be more positive to themselves", "If I express my appreciation through words or action more often, my children will appreciate the other family members more", "If I express my appreciation through words or action more often, my family will be happier and more harmonious".
Participants rated their agreement using a 10-point scale (1 = totally disagree, 10 = totally agree).
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Baseline (before the workshop, T1), and T2 (immediately after the workshop).
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Changes from baseline outcome expectancies of less criticism at post-workshop
Lasso di tempo: Baseline (before the workshop, T1), and T2 (immediately after the workshop).
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Measured by averaging three items.
"If I criticize my children, they will be more negative to themselves", "If I criticize my children, they will learn to criticize the other family members", "If I criticize my children, my family will be less happy and less harmonious".
Participants rated their agreement using a 10-point scale (1 = totally disagree, 10 = totally agree).
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Baseline (before the workshop, T1), and T2 (immediately after the workshop).
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Changes from baseline outcome expectancies of fruit and vegetable intake at post-workshop
Lasso di tempo: Baseline (before the workshop, T1), and T2 (immediately after the workshop).
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Measured by averaging two items.
"if I eat more servings of fruit and vegetables every day, that would be good for my health", "If I eat more fruit and vegetable, I will set a good example for my children".
Participants rated their agreement using a 10-point scale (1 = totally disagree, 10 = totally agree).
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Baseline (before the workshop, T1), and T2 (immediately after the workshop).
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Changes from baseline intention to express more appreciation at post-workshop and 2-week
Lasso di tempo: Baseline (before the workshop, T1), T2 (immediately after the workshop), and 2-week post-workshop (T3).
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Measured by a single item "In the coming 2 weeks, I intend to express appreciation to my child through words or action more often".
Participants rated their agreement on a 10-point scale (1 = totally disagree, 10 = totally agree).
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Baseline (before the workshop, T1), T2 (immediately after the workshop), and 2-week post-workshop (T3).
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Changes from baseline intention to criticize less at post-workshop and 2-week
Lasso di tempo: Baseline (before the workshop, T1), T2 (immediately after the workshop), and 2-week post-workshop (T3).
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Measured by a single item "In the coming 2 weeks, I intend to criticize my child less often".
Participants rated their agreement on a 10-point scale (1 = totally disagree, 10 = totally agree).
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Baseline (before the workshop, T1), T2 (immediately after the workshop), and 2-week post-workshop (T3).
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Changes from baseline intention of more fruit and vegetable intake at post-workshop and 2-week
Lasso di tempo: Baseline (before the workshop, T1), T2 (immediately after the workshop), and 2-week post-workshop (T3).
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Measured by a single item "in the coming 2 weeks, I intend to eat more servings of fruit and vegetables every day".
Participants rated their agreement on a 10-point scale (1 = totally disagree, 10 = totally agree).
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Baseline (before the workshop, T1), T2 (immediately after the workshop), and 2-week post-workshop (T3).
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Changes from baseline self-efficacy of more appreciation at post-workshop and 2-week
Lasso di tempo: Baseline (before the workshop, T1), T2 (immediately after the workshop), and 2-week post-workshop (T3).
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Measured by a single item "In the coming 2 weeks, I am confident that I can express appreciation to my child through words or action more often".
Participants rated their agreement on a 10-point scale (1 = totally disagree, 10 = totally agree).
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Baseline (before the workshop, T1), T2 (immediately after the workshop), and 2-week post-workshop (T3).
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Changes from baseline self-efficacy of less criticism at post-workshop and 2-week
Lasso di tempo: Baseline (before the workshop, T1), T2 (immediately after the workshop), and 2-week post-workshop (T3).
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Measured by a single item "In the coming 2 weeks, I am confident that I can criticize my child less often".
Participants rated their agreement on a 10-point scale (1 = totally disagree, 10 = totally agree).
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Baseline (before the workshop, T1), T2 (immediately after the workshop), and 2-week post-workshop (T3).
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Changes from baseline self-efficacy of more fruit and vegetable intake at post-workshop and 2-week
Lasso di tempo: Baseline (before the workshop, T1), T2 (immediately after the workshop), and 2-week post-workshop (T3).
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Measured by a single item "In the coming 2 weeks, I am confident that I could eat more servings of fruit and vegetables every day".
Participants rated their agreement on a 10-point scale (1 = totally disagree, 10 = totally agree).
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Baseline (before the workshop, T1), T2 (immediately after the workshop), and 2-week post-workshop (T3).
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Changes from baseline action planning of more appreciation at post-workshop, 2-week and 6-week
Lasso di tempo: Baseline (before the workshop, T1), T2 (immediately after the workshop), 2-week post-workshop (T3), and 6-week post-workshop (T4).
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Measured by a single item "In the coming 2 weeks, I have a clear plan on how to express appreciation to my child through words or action more often".
Participants rated their agreement on a 10-point scale (1 = totally disagree, 10 = totally agree).
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Baseline (before the workshop, T1), T2 (immediately after the workshop), 2-week post-workshop (T3), and 6-week post-workshop (T4).
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Changes from baseline action planning of less criticism at post-workshop, 2-week and 6-week
Lasso di tempo: Baseline (before the workshop, T1), T2 (immediately after the workshop), 2-week post-workshop (T3), and 6-week post-workshop (T4).
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Measured by a single item "In the coming 2 weeks, I have a clear plan on how to criticize my child less often.
Participants rated their agreement on a 10-point scale (1 = totally disagree, 10 = totally agree).
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Baseline (before the workshop, T1), T2 (immediately after the workshop), 2-week post-workshop (T3), and 6-week post-workshop (T4).
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Changes from baseline action planning of more fruit and vegetable intake at post-workshop, 2-week and 6-week
Lasso di tempo: Baseline (before the workshop, T1), T2 (immediately after the workshop), 2-week post-workshop (T3), and 6-week post-workshop (T4).
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Measured by a single item "In the coming 2 weeks, I have a clear plan on how to eat more servings of fruit and vegetables every day".
Participants rated their agreement on a 10-point scale (1 = totally disagree, 10 = totally agree).
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Baseline (before the workshop, T1), T2 (immediately after the workshop), 2-week post-workshop (T3), and 6-week post-workshop (T4).
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Changes from baseline coping planning of more appreciation at post-workshop, 2-week and 6-week
Lasso di tempo: Baseline (before the workshop, T1), T2 (immediately after the workshop), 2-week post-workshop (T3), and 6-week post-workshop (T4).
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Measured by a single item "In the coming 2 weeks, I have a clear plan on how to overcome challenges in expressing appreciation to my child through words or action more often".
Participants rated their agreement on a 10-point scale (1 = totally disagree, 10 = totally agree).
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Baseline (before the workshop, T1), T2 (immediately after the workshop), 2-week post-workshop (T3), and 6-week post-workshop (T4).
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Changes from baseline coping planning of less criticism at post-workshop, 2-week and 6-week
Lasso di tempo: Baseline (before the workshop, T1), T2 (immediately after the workshop), 2-week post-workshop (T3), and 6-week post-workshop (T4).
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Measured by a single item "in the coming 2 weeks, I have a clear plan on how to overcome challenges to criticize my child less often".
Participants rated their agreement on a 10-point scale (1 = totally disagree, 10 = totally agree).
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Baseline (before the workshop, T1), T2 (immediately after the workshop), 2-week post-workshop (T3), and 6-week post-workshop (T4).
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Changes from baseline coping planning of more fruit and vegetable intake at post-workshop, 2-week and 6-week
Lasso di tempo: Baseline (before the workshop, T1), T2 (immediately after the workshop), 2-week post-workshop (T3), and 6-week post-workshop (T4).
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Measured by a single item "In the coming 2 weeks, I have a clear plan on how to overcome challenges to eat more servings of fruit and vegetables every day".
Participants rated their agreement on a 10-point scale (1 = totally disagree, 10 = totally agree).
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Baseline (before the workshop, T1), T2 (immediately after the workshop), 2-week post-workshop (T3), and 6-week post-workshop (T4).
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Changes from baseline family well-being
Lasso di tempo: Baseline (before the workshop, T1), 2-week post-workshop (T3) and 6-week post-workshop (T4).
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Being assessed by a composite score of 3 items, namely the 3Hs: family harmony, family happiness, and family health.
Participants rated each item on a scale from 0 (not at all harmonious/ happy/ healthy) to 10 (very harmonious/ happy/ healthy).
This composite score has been used in another study in Hong Kong (M.
P. Wang et al., 2014) which showed a satisfactory Cronbach's alpha (0.84).
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Baseline (before the workshop, T1), 2-week post-workshop (T3) and 6-week post-workshop (T4).
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Samantha Fung, PhD, The University of Hong Kong
Pubblicazioni e link utili
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Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- HKUSPH-MALC
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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