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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Caregiver Burden

Intervention / Treatment
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* Other: Family program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All participants in a family program Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Affected family members of patients with Substance use disorders<br>The family sample was recruited from at a Norwegian addiction treatment unit where close relatives of patients in treatment for SUD participated in a family program. | Other: Family program<br>* A 4-day psychoeducational family program.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 |