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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • China
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Resilience group
Behavioral: 8-week Resilience Group Psychotherapy
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
Other: Usual care
Usual care means treating as usual, such as regular home visit.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Central South University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 30, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 27, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 8, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 8, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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