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NCT Number: NCT05665582

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

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.

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Key information

Conditions

Caregiver Burden Behavior Behavioral Symptoms Stress, Psychological

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Addiction Unit - Sørlandet Hospital

Kristiansand, Agder, 4600, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All participants in a family program

Exclusion criteria

  • None

Treatment and study plan

Family program

Other

A 4-day psychoeducational family program.

Primary outcomes

  1. Caregiver burden

    Time frame: Changes from baseline to the 3 months follow-up

    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).

  2. Family functioning

    Time frame: Changes from baseline to the 3 months follow-up

    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.

Secondary outcomes

  1. Mental distress

    Time frame: Changes from baseline to the 3 months follow-up

    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.

  2. Physical complaints

    Time frame: Changes from baseline to the 3 months follow-up

    Changes in physical complaints, measured on a 10-point ordinal scale (scaled 0 - 10) with higher score indicating more complaints.

  3. Well-being / quality of life

    Time frame: Changes from baseline to the 3 months follow-up

    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

Sponsors and collaborators

Lead sponsor

Sorlandet Hospital HF

Other Gov

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 27, 2022
Registry last updated
Jan 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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