Family Members Affected by Substance Use Disorder - a Follow-up Study

Caregiver Burden Clinical Trial

Official title:

Family Members Affected by Substance Use Disorder: How do They Cope and What Are Their Expressed Needs for Support?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05665582
• Other study ID #: SSHF_58-04
• Status: Completed
• Start date: January 1, 2016
• Est. completion date: December 31, 2017

Study information

• Verified date: January 2016
• Source: Sorlandet Hospital HF
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The present study registration relates to a quantitative sub-study of a larger mixed method study, including also a qualitative sub-study. Together, these investigations will provide complementary insights. The quantitative study is a follow-up study of close relatives (> 16 years) of patients in treatment for substance use disorder (SUD) who participated in a group-based 4-day psychoeducational program.

Description:

The study is a follow-up study of close relatives (> 16 years) of patients in treatment for SUDs who participated in a group-based 4-day psychoeducational program. The investigators will examine whether the family intervention in the specialized treatment services has benefits in terms of typical patient reported outcomes; physical complaints, psychological functioning, family functioning and QoL. The data collection has been finalized in 2017.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 271
• Est. completion date: December 31, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• All participants in a family program

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Caregiver Burden
• Substance-Related Disorders

Intervention

Other:
• Family program
A 4-day psychoeducational family program.

Locations

Country	Name	City	State
Norway	Addiction Unit - Sørlandet Hospital	Kristiansand	Agder

Sponsors (1)

Lead Sponsor	Collaborator
Sorlandet Hospital HF

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Vederhus JK, Kristensen O, Timko C. How do psychological characteristics of family members affected by substance use influence quality of life? Qual Life Res. 2019 Aug;28(8):2161-2170. doi: 10.1007/s11136-019-02169-x. Epub 2019 Mar 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Caregiver burden	Changes in Codependency symptomatology measured with the Composite Codependency Scale (CCS). Participants indicate the extent to which they agreed with each statement on a scale of 1 (strongly disagree) to 5 (strongly agree).	Changes from baseline to the 3 months follow-up
Primary	Family functioning	Changes in the general family functioning subscale (GFFS). Respondents complete 12 items with a four-point response scale (1 = strongly agree, 4 = strongly disagree). A mean score is computed and a higher score indicated greater family dysfunction.	Changes from baseline to the 3 months follow-up
Secondary	Mental distress	Changes in the the Hopkins Symptom Checklist (HSCL) 10-item version, which is used to measure mental distress. This 10-item index maps symptoms of anxiety (4 items) and depression (6 items) on 4-point Likert-type scales ranging from "not bothered at all" (1) to "extremely bothered" (4). The global severity index (GSI) constitutes the average of all items, with the highest score indicating greater symptom severity during the past week.	Changes from baseline to the 3 months follow-up
Secondary	Physical complaints	Changes in physical complaints, measured on a 10-point ordinal scale (scaled 0 - 10) with higher score indicating more complaints.	Changes from baseline to the 3 months follow-up
Secondary	Well-being / quality of life	Changes in Quality of Life measured with the QoL-5 scale (5 items). Responses are scored on a five-point scale ranging from very poor to very good QoL and then recoded into a decimal scale from 0.1 to 0.9, where 0.9 is the highest/best score and 0.1 the lowest/worst	Changes from baseline to the 3 months follow-up