NCT03328598

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 19, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 1, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2019

Completed
Last Updated

August 30, 2023

Status Verified

August 1, 2023

Enrollment Period

2 months

First QC Date

October 19, 2017

Last Update Submit

August 28, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Change of depression

    Pre-intervention, post-intervention, 3 month after finishing intervention, 1 year after finishing intervention

  • Change of subjective well-being

    Pre-intervention, post-intervention, 3 month after finishing intervention, 1 year after finishing intervention

  • Change of social avoidance

    Pre-intervention, post-intervention, 3 month after finishing intervention, 1 year after finishing intervention

  • Change of sleeping quality

    Pre-intervention, post-intervention, 3 month after finishing intervention, 1 year after finishing intervention

  • Change of post-traumatic growth

    Pre-intervention, post-intervention, 3 month after finishing intervention, 1 year after finishing intervention

  • +2 more secondary outcomes

Study Arms (3)

Positive psychology therapy group

EXPERIMENTAL

This arm will be given a positive psychological group intervention developed from an foreign psychotherapy.

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.

Behavioral: Resilience promotion therapy group

Controlled routine activity group

ACTIVE COMPARATOR

This arm will continue to participate in conventional community activities.

Other: Controlled routine activity

Interventions

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.

Positive psychology 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.

Resilience promotion therapy group

Conventional community activities is viewed as an active comparator for controlled group.

Controlled routine activity group

Eligibility Criteria

Age49 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • has given birth to only one child;
  • now has no living birth or adopted child;
  • the bereaved mother is older than 49 years in this family(medically maximum age for fertility in China).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Central South University

Changsha, Hunan, 410013, China

Location

Yangguang Tianshi Care Center

Changsha, Hunan, 410013, China

Location

Related Publications (10)

  • 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.

    PMID: 17014296BACKGROUND
  • 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.

    PMID: 25551421BACKGROUND
  • 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.

    PMID: 24756554BACKGROUND
  • 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.

    PMID: 23496405BACKGROUND
  • 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.

    PMID: 12416919BACKGROUND
  • 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.

    PMID: 23579259BACKGROUND
  • 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.

    PMID: 22472274BACKGROUND
  • 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.

    PMID: 25888685BACKGROUND
  • Seligman MEP, Rashid T, Parks AC. Positive psychotherapy. Am Psychol. 2006 Nov;61(8):774-788. doi: 10.1037/0003-066X.61.8.774.

    PMID: 17115810BACKGROUND
  • Seligman ME. Authentic happiness: Using the new positive psychology to realize your potential for lasting fulfillment(Simon and Schuster,2004.

    BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

October 19, 2017

First Posted

November 1, 2017

Study Start

December 1, 2017

Primary Completion

January 24, 2018

Study Completion

January 31, 2019

Last Updated

August 30, 2023

Record last verified: 2023-08

Locations