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

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

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.

Study Overview

• Status: Completed
• Conditions: Caregiver Burden
• Intervention / Treatment: Other: Family program

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 271

Contacts and Locations

Study Locations

• Norway
  • Agder
    • Kristiansand, Agder, Norway, 4600
      • Addiction Unit - Sørlandet Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Family members of patients in treatment for SUD at a Norwegian addiction treatment unit. The family members participated in a 4-day psychoeducational program

Description

Inclusion Criteria:

• All participants in a family program

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Affected family members of patients with Substance use disorders; 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; A 4-day psychoeducational family program.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sorlandet Hospital HF

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): June 30, 2017
• Study Completion (Actual): December 31, 2017

Study Registration Dates

• First Submitted: December 16, 2022
• First Submitted That Met QC Criteria: December 16, 2022
• First Posted (Actual): December 27, 2022

Study Record Updates

• Last Update Posted (Actual): January 4, 2023
• Last Update Submitted That Met QC Criteria: January 2, 2023
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Chemically-Induced Disorders; Stress, Psychological; Substance-Related Disorders; Caregiver Burden
• Other Study ID Numbers: SSHF_58-04

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