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Satir Model for Self-esteem, Mental Health, and Family Function Among Individuals With Substance Use Disorders

Primary Purpose

Drug Abuse, Self Esteem, Mental Health Wellness 1

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Satir group
Sponsored by
Hong Kong Metropolitan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Drug Abuse

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: aged 18 or above; are able to speak, read, and write Chinese; are willing to participate in the study and share their experience of the intervention with the research group; have informed consent to participate in the study. Exclusion Criteria: have been diagnosed with severe mental illnesses, such as schizophrenia, mania, antisocial personality disorder; have a diagnosed memory and cognitive impairment; are undergoing psychotherapeutic or psychopharmacologic treatment; are participating in similar studies.

Sites / Locations

  • Fangqiang compulsory isolation detoxification center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Satir group

Control group

Arm Description

Participants in the intervention group will receive a 10-session Satir model intervention.

Participants in the control group will receive care as usual.

Outcomes

Primary Outcome Measures

Self-esteem
The changes of participants' self-esteem will be assessed by using the Chinese version of Rosenberg self-esteem scale. Total scores range from 10 to 40, with higher scores representing lower self-esteem.

Secondary Outcome Measures

Adult attachment
Adult attachment will be assessed by using Adult attachment scale (AAS).The scale consists of 18 items scored on a 5 point likert-type scale. It measures adult attachment styles named "Secure", "Anxious" and "Avoidant".
Coping style
Coping style via Chinese version of simplified coping style questionnaire (SCSQ). It consists of 20 items referring to different ways of coping, with a total score range from 0 to 60. Two subscales are active coping and passive coping.
Self-efficacy
self-efficacy will be assessed by the general self-efficacy scale (GSES). The total score range from 10 to 40. Higher scores indicate higher perceived general self-efficacy
Meaning in life
Meaning in life will be assessed by using the Chinese version of meaning in life questionnaire (MLQ). It includes 10 items with a total score range from 10 to 70. It consists two subscales: MLQ Presence (MLQ-P) and Search (MLQ-S), each of them containing five items. The internal consistency of MLQ is 0.819.
Resilience
Resilience will be assessed via. the 25-item Connor-Davidson Resilience Scale (CD-RISC-25). The items are evaluated on a five-point likert scale ranging from 1 to 4. These ratings result in a number between 0-100, and higher scores indicate higher resilience.
Positive and negative affect scale
Positive and negative affect scale via Positive and negative affect scale (PANAS). This brief scale is comprised of 20 items, with 10 items measuring positive affect (e.g., excited, inspired) and 10 items measuring negative affect (e.g., upset, afraid). Scores can range from 10 to 50 for both the Positive and Negative Affect, with the lower scores representing lower levels of Positive/Negative Affect and higher scores representing higher levels of Positive/Negative Affect.
Drug craving
Drug craving will be assessed via the drug craving scale. It measures five dimensions of substance craving, including (1) prizing substance craving; (2) reflecting substance craving; (3) social substance craving; (4) negative substance craving; and (5) eliminating substance craving. The items are evaluated on a seven-point likert scale ranging from 1(strongly disagree) to 7 (strongly agree),
Motivation to abstain from drugs
Motivation to abstain from drugs will be assessed via the motivation to abstain from drugs. It includes 31 items, The items are evaluated on a five-point likert scale ranging from 1(strongly disagree) to 5 (strongly agree), with higher score indicates higher level of motivation to abstain from drugs.
Family function
Family function via the Chinese version of the 60-item McMaster Family Assessment Device (FAD). It includes seven subscale: problem solving, communication, roles, affective responsiveness, affective involvement, behavior control, and general function. The higher the overall score, the worse the level of family function.

Full Information

First Posted
September 11, 2023
Last Updated
October 18, 2023
Sponsor
Hong Kong Metropolitan University
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1. Study Identification

Unique Protocol Identification Number
NCT06044363
Brief Title
Satir Model for Self-esteem, Mental Health, and Family Function Among Individuals With Substance Use Disorders
Official Title
Assessing the Efficacy and Acceptability of the Satir Model on Self-esteem and Mental Health Among Individuals With Substance Use Disorders in China: A Pilot Study Protocol
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2023 (Actual)
Primary Completion Date
September 9, 2023 (Actual)
Study Completion Date
September 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hong Kong Metropolitan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Self-esteem and family functioning are associated with mental health and success of drug treatment among individuals with substance use disorders (SUD). The Satir model aims to empower individuals to explore their internal resources, address emotional issues, shift coping strategies, enhancing self-esteem, and develop healthier ways of relating to themselves and others. It offers a range of techniques to enhance self-esteem, challenging negative belief systems, and promote personal growth. The aim of the study is to investigate the acceptability and preliminary efficacy of the Satir model on self-esteem, mental health, and family function among individuals with SUD in China. The study will adopt a mixed-method approach. The quantitative phase will employ a randomized control trial (RCT) utilizing a pre-post study design. The qualitative phase will involve conducting semi-structured individual interviews.The data will be analyzed by using SPSS software package (IBM SPSS statistics version 26.0). The individual-interview will be analyzed by using the six-phase thematic analysis. The study has the potential to advance knowledge in the field of drug rehabilitation interventions, inform evidence-based practice, and improve the wellbeing and outcomes of individual with SUD. It can contribute to the ongoing efforts to address the complex challenges associated with substance use and support individual on their trajectory to recovery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Abuse, Self Esteem, Mental Health Wellness 1, Family Dysfunction

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
a single center, open-label, randomized, controlled trial
Masking
Participant
Masking Description
Open trial
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Satir group
Arm Type
Experimental
Arm Description
Participants in the intervention group will receive a 10-session Satir model intervention.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Participants in the control group will receive care as usual.
Intervention Type
Other
Intervention Name(s)
Satir group
Intervention Description
Participants in the intervention group will receive a 10-session, 3-hour/session intervention that spans over a period of five days (2 sessions/day). The intervention program will be conducted on specific weekends, with a gap of 1 to 2 weeks. The total duration of the intervention will be 30 hours.
Primary Outcome Measure Information:
Title
Self-esteem
Description
The changes of participants' self-esteem will be assessed by using the Chinese version of Rosenberg self-esteem scale. Total scores range from 10 to 40, with higher scores representing lower self-esteem.
Time Frame
Through study completion, an average of two months
Secondary Outcome Measure Information:
Title
Adult attachment
Description
Adult attachment will be assessed by using Adult attachment scale (AAS).The scale consists of 18 items scored on a 5 point likert-type scale. It measures adult attachment styles named "Secure", "Anxious" and "Avoidant".
Time Frame
Through study completion, an average of two months
Title
Coping style
Description
Coping style via Chinese version of simplified coping style questionnaire (SCSQ). It consists of 20 items referring to different ways of coping, with a total score range from 0 to 60. Two subscales are active coping and passive coping.
Time Frame
Through study completion, an average of two months
Title
Self-efficacy
Description
self-efficacy will be assessed by the general self-efficacy scale (GSES). The total score range from 10 to 40. Higher scores indicate higher perceived general self-efficacy
Time Frame
Through study completion, an average of two months
Title
Meaning in life
Description
Meaning in life will be assessed by using the Chinese version of meaning in life questionnaire (MLQ). It includes 10 items with a total score range from 10 to 70. It consists two subscales: MLQ Presence (MLQ-P) and Search (MLQ-S), each of them containing five items. The internal consistency of MLQ is 0.819.
Time Frame
Through study completion, an average of two months
Title
Resilience
Description
Resilience will be assessed via. the 25-item Connor-Davidson Resilience Scale (CD-RISC-25). The items are evaluated on a five-point likert scale ranging from 1 to 4. These ratings result in a number between 0-100, and higher scores indicate higher resilience.
Time Frame
Through study completion, an average of two months
Title
Positive and negative affect scale
Description
Positive and negative affect scale via Positive and negative affect scale (PANAS). This brief scale is comprised of 20 items, with 10 items measuring positive affect (e.g., excited, inspired) and 10 items measuring negative affect (e.g., upset, afraid). Scores can range from 10 to 50 for both the Positive and Negative Affect, with the lower scores representing lower levels of Positive/Negative Affect and higher scores representing higher levels of Positive/Negative Affect.
Time Frame
Through study completion, an average of two months
Title
Drug craving
Description
Drug craving will be assessed via the drug craving scale. It measures five dimensions of substance craving, including (1) prizing substance craving; (2) reflecting substance craving; (3) social substance craving; (4) negative substance craving; and (5) eliminating substance craving. The items are evaluated on a seven-point likert scale ranging from 1(strongly disagree) to 7 (strongly agree),
Time Frame
Through study completion, an average of two months
Title
Motivation to abstain from drugs
Description
Motivation to abstain from drugs will be assessed via the motivation to abstain from drugs. It includes 31 items, The items are evaluated on a five-point likert scale ranging from 1(strongly disagree) to 5 (strongly agree), with higher score indicates higher level of motivation to abstain from drugs.
Time Frame
Through study completion, an average of two months
Title
Family function
Description
Family function via the Chinese version of the 60-item McMaster Family Assessment Device (FAD). It includes seven subscale: problem solving, communication, roles, affective responsiveness, affective involvement, behavior control, and general function. The higher the overall score, the worse the level of family function.
Time Frame
Through study completion, an average of two months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: aged 18 or above; are able to speak, read, and write Chinese; are willing to participate in the study and share their experience of the intervention with the research group; have informed consent to participate in the study. Exclusion Criteria: have been diagnosed with severe mental illnesses, such as schizophrenia, mania, antisocial personality disorder; have a diagnosed memory and cognitive impairment; are undergoing psychotherapeutic or psychopharmacologic treatment; are participating in similar studies.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haixia Ma, PhD
Organizational Affiliation
Hong Kong Metropolitan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fangqiang compulsory isolation detoxification center
City
Yancheng
State/Province
Jiangsu
ZIP/Postal Code
224000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The relevant anonymized participant-level data, full dataset, technical appendix, and statistical code are available on reasonable request. The approval from the Principal Investigator for the purpose of data use is required.
IPD Sharing Time Frame
After the project is completed and the results of the project have been published.
IPD Sharing Access Criteria
Request could be sent to Principal Investigator (phxma@hkmu.edu.hk)

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Satir Model for Self-esteem, Mental Health, and Family Function Among Individuals With Substance Use Disorders

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