A Community-based Resilience Group Psychotherapy for Only-child Loss Parents in China

June 6, 2022 updated by: Anni Wang, Central South University

An 8-week Resilience-based Community Group Intervention Program for Parents Who Have Lost an Only Child in China

Two communities in Changsha was selected, where principle investigators' institution located, to recruit 80 participants into intervention group and control group. Resilience therapy group was intervened by a psychotherapy developed by the researchers, which lasts 8 weeks. The themes of each week are start-up, mutual help, trust in yourself, thanksgiving feedback, care for yourself, emotional management, end-up. Measurement was conducted before the intervention, immediately after intervention, 3-month after intervention, and 12-month after intervention. A questionnaire was used during each measurement, including several scales in it, including resilience and depression.The saliva test of Dehydroepiandrosterone was also done in each measurement.

Study Overview

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Hunan
      • Changsha, Hunan, China, 410013
        • Central South University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

49 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. had only one child but now passed away;
  2. failed to have another children;
  3. volunteered to participate;
  4. the score of resilience was under 72 points indicating a lower or middle level

Exclusion Criteria:

  1. in the acute bereavement period (<6 months);
  2. unable to participate in activities due to severe physical illness;
  3. receiving drug treatment for mental illness;
  4. receiving other psychological therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Resilience group
Resilience Group Psychotherapy 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.
Active Comparator: Controlled group
Usual care means treating as usual, such as regular home visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of resilience
Time Frame: Change from before intervention, immediately after intervention,3-month after intervention, to 12-month after intervention
A kind of ability to bounce back from adversity measured by Connor-Davidson Resilience Scale, with higher score reflecting higher level of resilience, ranging from 0-100.
Change from before intervention, immediately after intervention,3-month after intervention, to 12-month after intervention
Change of depression
Time Frame: Change from before intervention, immediately after intervention,3-month after intervention, to 12-month after intervention.
Depressive mood in recent two weeks measured by Zung Self-rated Depression Scale, with higher score reflecting higher level of depression, ranging from 0-80.
Change from before intervention, immediately after intervention,3-month after intervention, to 12-month after intervention.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of subjective well-being
Time Frame: Change from before intervention, immediately after intervention,3-month after intervention, to 12-month after intervention.
A feeling of happiness measured by Campbell Index of well-being, with higher score reflecting higher subjective well-being, ranging from 1.1 to 14.7.
Change from before intervention, immediately after intervention,3-month after intervention, to 12-month after intervention.
Change of social avoidance
Time Frame: Change from before intervention, immediately after intervention,3-month after intervention, to 12-month after intervention.
The phenomenon that a person is absent from normal social interaction with others measured by Social Avoidance and Distress Scale, with higher score reflecting higher social avoidance, ranging from 0 to 7.
Change from before intervention, immediately after intervention,3-month after intervention, to 12-month after intervention.
Change of sleeping quality
Time Frame: Change from before intervention, immediately after intervention,3-month after intervention, to 12-month after intervention.
Sleep quality in recent month measured by Pittsburgh sleep quality index, with higher score reflecting bad quality, ranging from 0 to 23.
Change from before intervention, immediately after intervention,3-month after intervention, to 12-month after intervention.
Change of post traumatic growth
Time Frame: Change from before intervention, immediately after intervention,3-month after intervention, to 12-month after intervention.
The positive growth after an adversity measured by Post Traumatic Growth Inventory, with higher score reflecting higher growth, ranging from 20 to 120.
Change from before intervention, immediately after intervention,3-month after intervention, to 12-month after intervention.
Change of concentration of dehydroepiandrosterone in saliva
Time Frame: Change from before intervention, immediately after intervention,3-month after intervention, to 12-month after intervention.
A kind of hormone that reflects the person's psychological stress collected by saliva collection tube by chewing the sterile cotton strips for 60 seconds, with higher concentration reflecting higher dehydroepiandrosterone level. The unit is pg/ml.
Change from before intervention, immediately after intervention,3-month after intervention, to 12-month after intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2017

Primary Completion (Actual)

January 30, 2018

Study Completion (Actual)

January 30, 2019

Study Registration Dates

First Submitted

May 27, 2022

First Submitted That Met QC Criteria

June 6, 2022

First Posted (Actual)

June 8, 2022

Study Record Updates

Last Update Posted (Actual)

June 8, 2022

Last Update Submitted That Met QC Criteria

June 6, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Resilience Group Psychotherapy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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