A Community-based Resilience Program of Only-child Loss Parents

Bereavement Clinical Trial

Official title:

Implementation of a Community-based Resilience Promotion Program to Only-child Loss Parents in China

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03328598
• Other study ID #: Central South University
• Status: Terminated
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: January 31, 2019

Study information

• Verified date: August 2023
• Source: Central South University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a community-based participatory research aiming at helping the only-child loss parents to be happier and resilient from bereavement. It is a psycho-behavioral intervention research. There are two intervention programs in this study. One is derived from a foreign psychotherapy, developed by an American psychologist and has been testified the effectiveness in promoting happiness. Another one is developed by the researchers based on the previous cross-sectional survey and interviews with those bereaved parents. The researchers will apply randomized controlled trial to testify and compare those two intervention programs in a Chinese community.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 144
• Est. completion date: January 31, 2019
• Est. primary completion date: January 24, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 49 Years and older

Eligibility

Inclusion Criteria(made according to the official documents):

1. has given birth to only one child;

2. now has no living birth or adopted child;

3. the bereaved mother is older than 49 years in this family(medically maximum age for fertility in China).

Exclusion Criteria:

1. with serious mental disorders or physical illnesses;

2. are not able to complete the intervention;

3. are not able to finish questionnaire;

4. with chewing functional disorder to collect saliva dehydroepiandrosterone.

Related Conditions & MeSH terms

• Bereavement
• Happiness
• Resilience,Psychological

Intervention

Behavioral:
• Positive psychology therapy group
This program is developed from a foreign group program based on positive psychology. The positive psychology therapy lasts 8 weeks, and has a group intervention in each week. The themes of each week are start-up, time gift, positive mind, three good things, a thankful heart, life train, active service, end-up.
• Resilience promotion therapy group
The other one is developed from research team's previous research results. The resilience promotion therapy lasts 8 weeks, and also has a group intervention in each week. The themes of each week are start-up, mutual help, trust in yourself, thanksgiving feedback, care for yourself, emotional management, end-up.

Other:
• Controlled routine activity
Conventional community activities is viewed as an active comparator for controlled group.

Locations

Country	Name	City	State
China	Central South University	Changsha	Hunan
China	Yangguang Tianshi Care Center	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Central South University

Country where clinical trial is conducted

China, 

References & Publications (10)

Bonanno GA, Wortman CB, Lehman DR, Tweed RG, Haring M, Sonnega J, Carr D, Nesse RM. Resilience to loss and chronic grief: a prospective study from preloss to 18-months postloss. J Pers Soc Psychol. 2002 Nov;83(5):1150-64. doi: 10.1037//0022-3514.83.5.1150. — View Citation

Chi P, Slatcher RB, Li X, Zhao J, Zhao G, Ren X, Zhu J, Stanton B. Perceived Stigmatization, Resilience, and Diurnal Cortisol Rhythm Among Children of Parents Living With HIV. Psychol Sci. 2015 Jun;26(6):843-52. doi: 10.1177/0956797615572904. Epub 2015 Apr 17. — View Citation

Galatzer-Levy IR, Bonanno GA. Beyond normality in the study of bereavement: heterogeneity in depression outcomes following loss in older adults. Soc Sci Med. 2012 Jun;74(12):1987-94. doi: 10.1016/j.socscimed.2012.02.022. Epub 2012 Mar 20. — View Citation

Jonas-Simpson C, Steele R, Granek L, Davies B, O'Leary J. Always with me: understanding experiences of bereaved children whose baby sibling died. Death Stud. 2015 Jan-Jun;39(1-5):242-51. doi: 10.1080/07481187.2014.991954. Epub 2014 Dec 31. — View Citation

Ong AD, Bergeman CS, Bisconti TL, Wallace KA. Psychological resilience, positive emotions, and successful adaptation to stress in later life. J Pers Soc Psychol. 2006 Oct;91(4):730-49. doi: 10.1037/0022-3514.91.4.730. — View Citation

Rosenberg AR, Starks H, Jones B. "I know it when I see it." The complexities of measuring resilience among parents of children with cancer. Support Care Cancer. 2014 Oct;22(10):2661-8. doi: 10.1007/s00520-014-2249-5. Epub 2014 Apr 23. — View Citation

Sanderson C, Lobb EA, Mowll J, Butow PN, McGowan N, Price MA. Signs of post-traumatic stress disorder in caregivers following an expected death: a qualitative study. Palliat Med. 2013 Jul;27(7):625-31. doi: 10.1177/0269216313483663. Epub 2013 Apr 11. — View Citation

Seligman ME. Authentic happiness: Using the new positive psychology to realize your potential for lasting fulfillment(Simon and Schuster,2004.

Seligman MEP, Rashid T, Parks AC. Positive psychotherapy. Am Psychol. 2006 Nov;61(8):774-788. doi: 10.1037/0003-066X.61.8.774. — View Citation

Stevens GJ, Dunsmore JC, Agho KE, Taylor MR, Jones AL, van Ritten JJ, Raphael B. Long-term health and wellbeing of people affected by the 2002 Bali bombing. Med J Aust. 2013 Mar 18;198(5):273-7. doi: 10.5694/mja12.11480. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of psychological resilience	Psychological resilience is a kind of ability to bounce back from adversity measured by Connor-Davidson Resilience Scale (CD-RISC).It is a self-reported scale by adding up 25 items and the total score ranges from 0-100, with higher score reflects higher resilience. The differences within two times frame are the changes of psychological resilience.	Pre-intervention, post-intervention, 3 month after finishing intervention, 1 year after finishing intervention
Secondary	Change of depression	Depression may refer to depressive mood in recent two weeks at each assessment measured by Zung Self-rating Depression Scale (SDS).It is a self-reported scale by adding up 20 items and the total score ranges from 20-80, with higher score reflects higher depression. The differences within time frames are changes of depression.	Pre-intervention, post-intervention, 3 month after finishing intervention, 1 year after finishing intervention
Secondary	Change of subjective well-being	A feeling of happiness measured by Campbell Index of well-being (IWB).It is a self-reported scale by adding up 8 items and the total score ranges from 2.1-14.7, with higher score reflects higher subjective well-being. The differences within time frames are change of subjective well-being.	Pre-intervention, post-intervention, 3 month after finishing intervention, 1 year after finishing intervention
Secondary	Change of social avoidance	The phenomenon that a person is absent from normal social interaction with others measured by Social Avoidance and Distress Scale(SAD). It is a self-reported scale by adding up 14 items and the total score ranges from 0-14, with higher score reflects social avoidance. The differences within two time frame are the changes of social avoidance.	Pre-intervention, post-intervention, 3 month after finishing intervention, 1 year after finishing intervention
Secondary	Change of sleeping quality	The sleeping quality is a response of one's mood in recent month measured by Pittsburgh sleep quality index(PSQI). It is a self-reported scale, with total score higher than 19 reflects sleeping disorder. The differences within each time frames are the changes of sleeping quality.	Pre-intervention, post-intervention, 3 month after finishing intervention, 1 year after finishing intervention
Secondary	Change of post-traumatic growth	The positive growth after an adversity measured by Post Traumatic Growth Inventory(PTGI). It is a self-reported scale by adding up 24 items and the total score ranges from 0-120, with higher score reflects more growth. The differences within time frames are changes of post-traumatic growth.	Pre-intervention, post-intervention, 3 month after finishing intervention, 1 year after finishing intervention
Secondary	Change of health care behavior	A person's self-care behavior measured by Health Promoting Lifestyle Profile-?( HPLP-?).It is a self-reported scale by adding up 40 items in four dimensions. The total score ranges from 40-160, with higher score reflects better health care behavior. The differences within time frames are changes of health care behavior.	Pre-intervention, post-intervention, 3 month after finishing intervention, 1 year after finishing intervention
Secondary	Change of concentration of dehydroepiandrosterone in saliva	A kind of hormone that reflects the person's psychological stress collected by Sarstedt(Brand name) saliva collection tube by chewing the sterile cotton strips for 60 seconds. It will be tested by enzyme-linked immunosorbent assay (ELISA) with Kit Number of HT81012 and Origin site in Canada PLlabs(Company name). The differences within time frames are changes of dehydroepiandrosterone concentration in saliva.	Pre-intervention, post-intervention, 3 month after finishing intervention, 1 year after finishing intervention