Resilience,PsychologicalNCT03328598
A Community-based Resilience Program of Only-child Loss Parents
A study testing Positive psychology therapy group and Resilience promotion therapy group in people with Resilience,Psychological and Bereavement, run by Central South University at 2 sites in China.
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. Read more about this study
- Who is it for?
- Ages 49 years and olderHealthy volunteers can take part
- Conditions the study is for
- Resilience,Psychological, Bereavement, Happiness
- What is being tested?
- Positive psychology therapy group and Resilience promotion therapy group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 2 sitesChina
- Study dates
- 1 Dec 2017to 31 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 49 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- with serious mental disorders or physical illnesses;
- are not able to complete the intervention;
- are not able to finish questionnaire;
- with chewing functional disorder to collect saliva dehydroepiandrosterone.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Central South University
Changsha, Hunan, 410013
Yangguang Tianshi Care Center
Changsha, Hunan, 410013
About this study
Official title: Implementation of a Community-based Resilience Promotion Program to Only-child Loss Parents in China
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.
- Conditions
- Resilience,Psychological, Bereavement, Happiness
- Being tested
- Positive psychology therapy group, Resilience promotion therapy group, Controlled routine activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive psychology therapy groupBehavioural
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 groupBehavioural
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.
Controlled routine activityOther
Conventional community activities is viewed as an active comparator for controlled group.
| Study group | Role | What they receive |
|---|---|---|
| Positive psychology therapy group | Experimental | This arm will be given a positive psychological group intervention developed from an foreign psychotherapy. Receives: Behavioral: Positive psychology therapy group |
| Resilience promotion therapy group | Experimental | This arm will be given a resilience group intervention developed from our pervious research results. Receives: Behavioral: Resilience promotion therapy group |
| Controlled routine activity group | Active comparator | This arm will continue to participate in conventional community activities. Receives: Other: Controlled routine activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-intervention, post-intervention, 3 month after finishing intervention, 1 year after finishing intervention
Secondary outcomes (7)
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.
Measured: Pre-intervention, post-intervention, 3 month after finishing intervention, 1 year after finishing intervention
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.
Measured: Pre-intervention, post-intervention, 3 month after finishing intervention, 1 year after finishing intervention
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.
Measured: Pre-intervention, post-intervention, 3 month after finishing intervention, 1 year after finishing intervention
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.
Measured: Pre-intervention, post-intervention, 3 month after finishing intervention, 1 year after finishing intervention
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.
Measured: Pre-intervention, post-intervention, 3 month after finishing intervention, 1 year after finishing intervention
Change of health care behavior
A person's self-care behavior measured by Health Promoting Lifestyle Profile-Ⅱ( HPLP-Ⅱ).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.
Measured: Pre-intervention, post-intervention, 3 month after finishing intervention, 1 year after finishing intervention
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.
Measured: Pre-intervention, post-intervention, 3 month after finishing intervention, 1 year after finishing intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2017
- Study start1 Dec 2017
- Primary completion24 Jan 2018
- Study completion31 Jan 2019
Why it stopped: Don't have enough funding to finish the project.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Resilience,PsychologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anni Wang, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03328598
- Sponsor's protocol ID
- Central South University
- Status last verified
- Aug 2023
- First submitted
- 19 Oct 2017
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: In our previous field investigation, most participants, as a vulnerable goup, are not willing to share their personal data to the public. Hence, we are not sure whether the recruited participants will agree to share the data.
Publications
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.
PubMed 17014296Jonas-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.
PubMed 25551421Rosenberg 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.
PubMed 24756554Stevens 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.
PubMed 23496405Bonanno 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.
PubMed 12416919Sanderson 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.
PubMed 23579259Galatzer-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.
PubMed 22472274Chi 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.
PubMed 25888685Seligman MEP, Rashid T, Parks AC. Positive psychotherapy. Am Psychol. 2006 Nov;61(8):774-788. doi: 10.1037/0003-066X.61.8.774.
PubMed 17115810Seligman ME. Authentic happiness: Using the new positive psychology to realize your potential for lasting fulfillment(Simon and Schuster,2004.
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Community-based Resilience Promotion Program to Only-child Loss Parents in China
- ClinicalTrials.gov ID
- NCT03328598
- Acronym / sponsor ID
- Central South University
- Conditions
- Resilience,Psychological, Bereavement, Happiness
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Don't have enough funding to finish the project.
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Central South UniversityUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 24 Jan 2018 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 1 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Positive psychology therapy group | Experimental | Behavioral: Positive psychology therapy groupThis arm will be given a positive psychological group intervention developed from an foreign psychotherapy. |
| Resilience promotion therapy group | Experimental | Behavioral: Resilience promotion therapy groupThis arm will be given a resilience group intervention developed from our pervious research results. |
| Controlled routine activity group | Active comparator | Other: Controlled routine activityThis arm will continue to participate in conventional community activities. |
Who may qualify
- Ages
- 49 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- with serious mental disorders or physical illnesses;
- are not able to complete the intervention;
- are not able to finish questionnaire;
- with chewing functional disorder to collect saliva dehydroepiandrosterone.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Positive psychology therapy groupThis 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. | Behavioural | Positive psychology therapy group |
| Resilience promotion therapy groupThe 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. | Behavioural | Resilience promotion therapy group |
| Controlled routine activityConventional community activities is viewed as an active comparator for controlled group. | Other | Controlled routine activity group |
Primary outcome
Change of psychological resilience
Time frame: Pre-intervention, post-intervention, 3 month after finishing intervention, 1 year after finishing intervention
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.
7 secondary outcomes
Change of depression
Time frame: Pre-intervention, post-intervention, 3 month after finishing intervention, 1 year after finishing intervention
Change of subjective well-being
Time frame: Pre-intervention, post-intervention, 3 month after finishing intervention, 1 year after finishing intervention
Change of social avoidance
Time frame: Pre-intervention, post-intervention, 3 month after finishing intervention, 1 year after finishing intervention
Change of sleeping quality
Time frame: Pre-intervention, post-intervention, 3 month after finishing intervention, 1 year after finishing intervention
Change of post-traumatic growth
Time frame: Pre-intervention, post-intervention, 3 month after finishing intervention, 1 year after finishing intervention
Change of health care behavior
Time frame: Pre-intervention, post-intervention, 3 month after finishing intervention, 1 year after finishing intervention
Change of concentration of dehydroepiandrosterone in saliva
Time frame: Pre-intervention, post-intervention, 3 month after finishing intervention, 1 year after finishing intervention
Results and safety
The study was stopped early (reason given: Don't have enough funding to finish the project.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
- Background: PubMed 17014296Ong 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.
- Background: PubMed 25551421Jonas-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.
- Background: PubMed 24756554Rosenberg 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.
- Background: PubMed 23496405Stevens 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.
- Background: PubMed 12416919Bonanno 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.
- Background: PubMed 23579259Sanderson 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.
- Background: PubMed 22472274Galatzer-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.
- Background: PubMed 25888685Chi 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.
- Background: PubMed 17115810Seligman MEP, Rashid T, Parks AC. Positive psychotherapy. Am Psychol. 2006 Nov;61(8):774-788. doi: 10.1037/0003-066X.61.8.774.
- BackgroundSeligman ME. Authentic happiness: Using the new positive psychology to realize your potential for lasting fulfillment(Simon and Schuster,2004.
- Individual participant dataSharing planned: Undecided. In our previous field investigation, most participants, as a vulnerable goup, are not willing to share their personal data to the public. Hence, we are not sure whether the recruited participants will agree to share the data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive psychology therapy group and Resilience promotion therapy group in people with Resilience,Psychological and Bereavement, run by Central South University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Don't have enough funding to finish the project.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of psychological resilience (time frame: Pre-intervention, post-intervention, 3 month after finishing intervention, 1 year after finishing intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03328598, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2023.