Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06446089
Status:
RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-05-23
Brief Title:
A Chinese Version of the Thinking Health Program for East Asian Pregnant Immigrant People in Canada
Sponsor:
Shahirose Sadrudin Premji
Organization:
Queens University
Study Overview
Official Title:
The Feasibility of a Culturally Tailored Mobile App-based Thinking Healthy Program for Mental Health Support of East Asian Pregnant Immigrants in Canada
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this study is to determine the feasibility of using a psychosocial intervention culturally adapted in China to support perinatal mental well-being of Chinese immigrant pregnant women in Canada The intervention is adapted from the Thinking Healthy Program THP available through a mobile application and will be offered to Chinese immigrant pregnant women 22 weeks gestation or greater residing in Canada who are over the age of 18 and speak Mandarin The main questions this study aims to answer are
Will the Chinese version of the THP be acceptable to Chinese immigrant pregnant women residing in Canada and will they use the program which is delivered through a mobile App
How well does the process of recruiting keeping participants in the study and helping them complete the activities work so it can be used for a future larger study
Women interested in the study and who meet the study criteria will complete a questionnaire at the start of the study then use the THP for three weeks complete questionnaires 3-4 weeks after completing the intervention and 6-8 weeks after having their babyies Some may be asked to participate in an individual interview
Will the Chinese version of the THP be acceptable to Chinese immigrant pregnant women residing in Canada and will they use the program which is delivered through a mobile App
How well does the process of recruiting keeping participants in the study and helping them complete the activities work so it can be used for a future larger study
Women interested in the study and who meet the study criteria will complete a questionnaire at the start of the study then use the THP for three weeks complete questionnaires 3-4 weeks after completing the intervention and 6-8 weeks after having their babyies Some may be asked to participate in an individual interview
Detailed Description:
Common mental health conditions during pregnancy include depression and anxiety Having an immigrant status and belonging to an ethnic minority group is linked to an increased likelihood of perinatal mental health problems The lack of culturally tailored and innovative intervention is a predominant factor affecting mental health outcomes for immigrant women Psychological and psychosocial interventions have been reported to significantly improve non-migrant womens mental health The Thinking Healthy Program THP a low-intensity low-cost psychosocial intervention talking therapies based on cognitive behavioural therapy is comprised of 12 1-hour sessions with content organized in modules eg preparing for the baby babys arrival that have associated activities eg mood chart In China the THP has been culturally and linguistically adapted using rigorous processes and delivered to support women in the management of perinatal depression To improve access and ensure a more impactful outcome to the culturally adapted THP a mobile App was created in China with a brief Chinese version of the culturally adapted THP
The primary objective of this study is to 1 assess the feasibility acceptability and usability of the linguistically and culturally adapted THP delivered through a mobile App to Chinese immigrant pregnant women residing in Canada and 2 examine the process of recruitment retention and adherence to intervention to inform a future trial The secondary objective is to produce preliminary evidence on the effectiveness of the brief Chinese version of THP on immigrant womens mental well-being specifically depression
A sequential explanatory mixed-method feasibility study involving a pre-post design in which a single group will be assembled and assessed quantitatively at baseline 3-4 weeks post completion of brief Chinese version of the THP intervention and again at 6-8 weeks following the birth of their baby A subset of participants that have engaged with the intervention nup to 15 will be invited to individual semi-structured telephone interview to share their experience with the intervention
A convenience sample of 50 participants will be recruited for the intervention with a subset of 15 participants to be individually interviewed via the telephone
Participants will be recruited through social media WeChat and Xiaohongshu research team members University mailing list dissemination to professional colleagues eg Obstetrics and Gynecologists and collaboration with social and health-based organizations that serve the East Asian community in Canada
At baseline the sociodemographic characteristics immigrant characteristics healthobstetric history and history of psychological well-being will be assessed Potential covariates that will be assessed once include acculturation baseline Vancouver Index of Acculturation and preterm birth at 6 to 8 weeks postpartum while all others including pregnancy-related anxiety Pregnancy-Related Anxiety Scale somatic symptoms Patient Health Questionnaire-15 psychological stress Perceived Stress Scale-10 resilience Connor-Davidson Resilience Scale-10 social support Multidimensional Scale of Perceived Social Support mother-infant relationship prenatal section of the Pre- and Postnatal Bonding Scale and patient activation Behavioural Activation for Depression Scale will be assessed at baseline and follow-up after intervention andor 6 to 8 weeks postpartum using the scales and instruments listed above
The primary objective of this study is to 1 assess the feasibility acceptability and usability of the linguistically and culturally adapted THP delivered through a mobile App to Chinese immigrant pregnant women residing in Canada and 2 examine the process of recruitment retention and adherence to intervention to inform a future trial The secondary objective is to produce preliminary evidence on the effectiveness of the brief Chinese version of THP on immigrant womens mental well-being specifically depression
A sequential explanatory mixed-method feasibility study involving a pre-post design in which a single group will be assembled and assessed quantitatively at baseline 3-4 weeks post completion of brief Chinese version of the THP intervention and again at 6-8 weeks following the birth of their baby A subset of participants that have engaged with the intervention nup to 15 will be invited to individual semi-structured telephone interview to share their experience with the intervention
A convenience sample of 50 participants will be recruited for the intervention with a subset of 15 participants to be individually interviewed via the telephone
Participants will be recruited through social media WeChat and Xiaohongshu research team members University mailing list dissemination to professional colleagues eg Obstetrics and Gynecologists and collaboration with social and health-based organizations that serve the East Asian community in Canada
At baseline the sociodemographic characteristics immigrant characteristics healthobstetric history and history of psychological well-being will be assessed Potential covariates that will be assessed once include acculturation baseline Vancouver Index of Acculturation and preterm birth at 6 to 8 weeks postpartum while all others including pregnancy-related anxiety Pregnancy-Related Anxiety Scale somatic symptoms Patient Health Questionnaire-15 psychological stress Perceived Stress Scale-10 resilience Connor-Davidson Resilience Scale-10 social support Multidimensional Scale of Perceived Social Support mother-infant relationship prenatal section of the Pre- and Postnatal Bonding Scale and patient activation Behavioural Activation for Depression Scale will be assessed at baseline and follow-up after intervention andor 6 to 8 weeks postpartum using the scales and instruments listed above
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| FRN 154988 | OTHER_GRANT | Canadian Institutes of Health Research | None |