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

Study Overview
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Brief Summary
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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.

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

Conditions
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Resilience,Psychological, Bereavement, Happiness

Intervention / Treatment
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* Behavioral: Positive psychology therapy group
* Behavioral: Resilience promotion therapy group
* Other: Controlled routine activity


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria(made according to the official documents): 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). Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 49 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Positive psychology therapy group<br>This arm will be given a positive psychological group intervention developed from an foreign psychotherapy. | Behavioral: Positive psychology therapy group<br>* 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.<br>|
| Experimental: Resilience promotion therapy group<br>This arm will be given a resilience group intervention developed from our pervious research results. | Behavioral: Resilience promotion therapy group<br>* 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.<br>|
| Active Comparator: Controlled routine activity group<br>This arm will continue to participate in conventional community activities. | Other: Controlled routine activity<br>* Conventional community activities is viewed as an active comparator for controlled group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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. | 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. | Pre-intervention, post-intervention, 3 month after finishing intervention, 1 year after finishing intervention |