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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03328598
Enrollment
144
Registered
2017-11-01
Start date
2017-12-01
Completion date
2019-01-31
Last updated
2023-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bereavement, Happiness, Resilience,Psychological

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.

Interventions

BEHAVIORALPositive 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.

BEHAVIORALResilience 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.

OTHERControlled routine activity

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

Sponsors

Central South University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
49 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change of psychological resiliencePre-intervention, post-intervention, 3 month after finishing intervention, 1 year after finishing interventionPsychological 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.

Secondary

MeasureTime frameDescription
Change of subjective well-beingPre-intervention, post-intervention, 3 month after finishing intervention, 1 year after finishing interventionA 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.
Change of social avoidancePre-intervention, post-intervention, 3 month after finishing intervention, 1 year after finishing interventionThe 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.
Change of sleeping qualityPre-intervention, post-intervention, 3 month after finishing intervention, 1 year after finishing interventionThe 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.
Change of depressionPre-intervention, post-intervention, 3 month after finishing intervention, 1 year after finishing interventionDepression 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.
Change of health care behaviorPre-intervention, post-intervention, 3 month after finishing intervention, 1 year after finishing interventionA 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.
Change of concentration of dehydroepiandrosterone in salivaPre-intervention, post-intervention, 3 month after finishing intervention, 1 year after finishing interventionA 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.
Change of post-traumatic growthPre-intervention, post-intervention, 3 month after finishing intervention, 1 year after finishing interventionThe 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026