An 8-week Resilience-based Community Group Intervention Program for Parents Who Have Lost an Only Child in China
Phase: NA
Conditions: Depression
Sponsor: Central South University

Full study protocol and statistical analysis plan 
 
Official Title of the study: 
A Community-based Resilience Group Psychotherapy for Only-child Loss 
Parents in China 
 
Date of the document: 
6th June 2022 
 
Contents: 
1. Participant Flow 
2. Baseline Characteristics 
3. Outcome Measures 
4. Adverse Event Information 
5. Limitations and Caveats 
6. Certain Agreements 
7. Results Point of Contact 
 
 
 

1. Participant Flow 
Recruitment Details  
We will choose two communities in Changsha, where principle investigators’ institution located, 
to recruit the participants. This community has a social organization to serve the bereaved only 
child lost parents. The recruitment started at Nov 1st 2017. The recruitment announcement was 
distributed to the participants via social worker in their daily online chat group or through 
telephone call. 
Pre-assignment Details [*]  
We firstly assessed the recruited people to ensure meeting the inclusion and exclusion criteria. 
The inclusion criteria are made according to the official documents. OCL Family is one that has 
given birth to only one child but now has no living birth or adopted child, and the bereaved 
mother is older than 49 years (medically maximum age for fertility in China). 
Those with serious mental disorders or physical illnesses who were not able to complete the 
intervention and evaluation questionnaire will be excluded. 
Than the final enrolled participants can be sure and randomized assignment will be conducted. 
Enrollment (total, anticipatory) 
80 
Record the number of the 
eligible and the excluded 
Allocation (randomized)  
Intervention 
group 
Treat 
as 
usual group 
Record the number of the 
received and the unreceived 
 
40 
40 
Follow-up  
(immediately 
after 
intervention)  
 
 
The 
numbers 
of 
each 
follow-up stages are uncertain 
by now. But in the latter 
research, 
we 
will 
record 
information of the lost and the 
continued. 
Follow-up 
(3-month after intervention) 
 
 
Follow-up 
(12-month after intervention) 
 
 
 
Arm/Group Information *  
There are two groups in the study.  
Arm/Group Title *  
Resilience therapy group= Intervention group 
Controlled routine activity group= Treat as usual group 
Arm/Group Description *§  
Resilience therapy group was intervened by a psychotherapy developed by the researchers. 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 activity group will have routine service delivered by social workers. This group 
will have routine service delivered by social workers. 
 
Period(s) *  
There is only one stage in the study.  
Period Title *  
Overall Study.  
Started *  
There will be 80 participants initiating the intervention with around 40 participants in each 
group.  
Completed *  
We did follow-up, and the number in each follow-up was recorded. 
Milestone Title [*]  
Before the intervention, we measured the participants, and the stage is defined as T0. 
We did follow-up immediately after intervention, 3-month after intervention, 12-month after 
intervention, defined as T1, T2, T3 respectively.  

Reason Not Completed Type [*]  
We recorded the exact reason (Adverse Event) why participants do not complete the study. The 
reason may be death, lack of efficacy, lost to follow-up, illness, withdrawing by subject or others. 
 
 
2. Baseline Characteristics 
Arm/Group Information *  
Chi-square test was applied to figure out the difference of enumeration data among three groups. 
ANOVA was applied to test the difference of measurement data among three groups. F values 
and χ2 values was displayed to show the different in two groups.  
Arm/Group Title *  
Resilience therapy group 
Controlled routine activity group 
Arm/Group Description *§  
All the recruited participants was numbered and randomly allocated into two groups by random 
number table. The grouping results was announced to the participants. 
 
Overall Number of Baseline Participants *  
There was 80 participants initiating the intervention.  
Baseline Measure Information *  
A group of demographic characteristics was measured in the study, including gender, age, marital 
status, income per month, gender of lost kid, length of lost kid. 
Baseline Measure Title *  
• 
Age * : Continuous(years) 
• 
Gender * : Female, Male  
• 
Marital status: with a spouse, without a spouse 
• 
Income per month: Categorical: 
• 
<=1000 RMB 
• 
>1000 and <2000 RMB 
• 
>=2000 RMB 
• 
Gender of lost kid: Female, Male 
• 
Length of lost kid: Continuous(years) 
Measure Type *  
• 
Count of Participants: Gender, Marital status  
• 
Mean: Age, Length of lost kid 
• 
Number: Gender of lost kid, Income per month 
Measure of Dispersion *  
• 
Standard Deviation 
• 
Inter-Quartile Range 
• 
Full Range 
Baseline Measure Data *  
The value(s) for each baseline measure was listed below.  
Table 1 Socio-demographic variables among two groups 
 
Resilience 
therapy group 
(n=42) 
Controlled 
group (n=38) 
χ2 /t 
P 
Gender 
 
 
 
 
Male  
16 
13 
0.13 
0.78 
Female 
26 
25 
 
 
Religion* 
 
 
 
 
Yes  
41 
35 
1.27 
0.25 
No  
1 
3 
 
 
Marital status 
 
 
 
 
Married/remarried 
35 
28 
1.11 
0.29 

  Divorced/widowed 
7 
10 
 
 
Education level 
 
 
 
 
  Junior high school and below 
19 
21 
0.80 
0.37 
  Senior high school and above 
23 
17 
 
 
Per capita monthly income (¥)* 
 
 
 
 
  ≤1000 
4 
5 
2.04 
0.36 
1001-2000  
17 
20 
 
 
≥2000 
21 
13 
 
 
Chronic disease 
 
 
 
 
Yes  
14 
15 
0.32 
0.56 
No  
28 
23 
 
 
Gender of child 
 
 
 
 
Male  
34 
27 
1.08 
0.29 
Female 
8 
11 
 
 
Reason of child loss* 
 
 
 
 
  Acute disease 
13 
11 
1.09 
0.77 
Chronic disease 
15 
14 
 
 
Accident 
12 
9 
 
 
  Suicide or others 
2 
4 
 
 
Grandchild 
 
 
 
 
Yes  
33 
28 
0.26 
0.60 
No  
9 
10 
 
 
Age of participants (year) 
62.35±6.14 
60.13±5.57 
1.71 
0.09 
Age of child (year) 
27.68±7.71 
28.90±5.11 
0.74 
0.45 
Length of child loss (year) 
12.04±5.91 
10.67±4.32 
1.17 
0.24 
Note: Income is valued in Chinese currency unit, with ¥2,000 RMB≈$314 USD. *The number of 
grids with theoretical number less than 5 exceeds 1/5, Fisher exact probability was applied.  
 
 
 3. Outcome Measures 
Outcome Measure Information *  
A questionnaire was used during each measurement, including several scales in it. 
The saliva test of Dehydroepiandrosterone was also done in each measurement.  
Outcome Measure Type *  
• 
Primary 
Outcome Measure Title *  
• 
Psychological resilience: 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 
• 
Depression: depressive mood in recent two weeks measured by Zung Self-rated 
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 
• 
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 
• 
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 time frames are the 
changes of social avoidance 

• 
Sleeping quality: a reflection 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 
• 
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 
• 
Concentration of dehydroepiandrosterone in saliva: a kind of hormone that reflects the 
person's psychological stress collected by Sarstedt 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 
Outcome Measure unit * 
The psychological resilience, depression, subjective well-being, social avoidance, sleeping quality, 
and post traumatic growth are measured by scales with no unit. 
Dehydroepiandrosterone has its concentration unit of pg/ml. 
Outcome Measure Time Frame *  
There were four measurements, before the intervention, immediately after intervention, 
3-month after intervention, and 12-month after intervention. They are defined as T0, T1, T2, T3 
respectively. 
 
Analysis Population Information  
Overall Number of Participants Analyzed *  
There was 80 participants totally enrolled in the study.  
Outcome Measure Data Table  
Measure Type *  
• 
Mean 
Measure of Dispersion/Precision *  
• 
Standard Deviation 
Outcome Data *  
Table 2 Descriptive data, change and effect size between group comparisons for primary and 
secondary outcomes at four time points 
 
 
M(SD) of control group 
M(SD) of intervention group 
Resilience 
T0 
51.84 (15.58) 
55.19 (12.04) 
 
T1 
52.61 (13.97) 
65.86 (13.87) 
 
T2 
53.79 (15.11) 
65.05(10.28) 
 
T3 
63.12(13.91) 
64.53(14.16) 
Depression 
T0 
54.42(7.90) 
51.63(6.43) 
 
T1 
52.95(7.98) 
44.75(10.15) 
 
T2 
50.76(7.22) 
44.36(8.32) 
 
T3 
50.70(7.28) 
40.21(10.92) 
PTG 
T0 
56.13(15.68) 
53.50(14.67) 
 
T1 
58.66(15.47) 
70.62(14.66) 
 
T2 
61.05(16.06) 
71.19(11.62) 
 
T3 
61.16(14.99) 
71.57(11.32) 
IWB 
T0 
8.65(2.34) 
8.98(1.94) 
 
T1 
8.81(1.99) 
10.41(2.44) 
 
T2 
9.25(1.90) 
10.43(1.83) 
 
T3 
9.42(2.20) 
10.53(1.99) 
SAD 
T0 
10.89(1.75) 
10.12(2.35) 
 
T1 
10.07(1.31) 
4.95(4.85) 
 
T2 
9.15(2.06) 
4.32(4.49) 
 
T3 
6.99(3.83) 
4.50(4.57) 
Sleep 
T0 
7.25(3.71) 
7.76(3.32) 

 
T1 
7.14(3.48) 
7.31(2.85) 
 
T2 
6.63(3.22) 
7.90 (5.83) 
 
T3 
7.68(4.02) 
6.43(3.00) 
DHEA 
T0 
43.95(27.21) 
48.86(20.47) 
 
T1 
45.40(32.23) 
50.38(31.44) 
 
T2 
43.19(29.33) 
50.87(27.01) 
 
T3 
44.25(22.59) 
50.87 (32.67) 
 
 
 
Statistical Analysis Overview  
Comparison Group Selection [*]  
We compared two groups’ data.  
Type of Statistical Test [*]  
• 
Superiority 
• 
Other (descriptive analysis) 
P-Value [*]  
P-Value will be set at 0.05. 
Method [*]  
• 
ANOVA 
• 
Chi-Squared 
• 
t-Test, 2-Sided 
• 
Other: repeated measurement of variance analysis within different measurements 
among different groups  
Estimation Parameter [*]  
• 
Mean Difference (Final Values) 
 
 
 4. Adverse Event Information 
Time Frame *§  
The intervention lasted 8 weeks, and we recorded the adverse event each week.  
We did follow-up immediately after intervention, 3-month after intervention, and 12-month after 
intervention, and recorded the adverse event at each follow-up. 
Adverse Event Reporting Description [*]  
We added relevant information about adverse event after finishing the study.   
Collection Approach for Table Default *§ 
• 
Systematic Assessment: The psychotherapist routinely determined whether or not 
certain adverse events had occurred through regular investigator assessment during 
intervention and in each follow-up. 
• 
Non-Systematic Assessment: Self-reporting by participants or occasional assessment by 
the psychotherapist. 
Adverse Event Term *  
Most possible adverse event may be the psychological discomfort because the participants are 
experiencing bereavement. We provided information for in three tables summarizing adverse 
events in each group, including all-cause mortality, serious adverse events, and other (not 
including serious) adverse events.  
Organ System *  
• 
Psychiatric Disorders 
 
 
5. Limitations and Caveats 
There may be several limitations. The measurements are mostly based on self-reported scales 
and may lead to unreliable data. We gave instruction before fulfilling the questionnaire to ensure 
the participants understood. 

 
6. Certain Agreements 
Are all PIs Employees of Sponsor? *  
• 
No: The principal investigator is not an employee of the sponsor 
There is no agreement between the agent (university) and the principal investigators. The 
principal investigators are graduate students in the university. The principal investigators (PIs) can 
discuss the results of the study at a scientific meeting or any other public or private forum, or to 
publish in a scientific or academic journal information concerning the results of the study. 
 
 
7. Results Point of Contact 
Name or Official Title *  
Professor: Jingping Zhang 
Position title: Director of Nursing Psychology Research Center 
Organization Name *  
Nursing Psychology Research Center, Xiangya School of Nursing, Central South University 
Phone: *§  +86-13873127168 
Email: *§  jpzhang1965@csu.edu.cn