The Preliminary Evaluation of Supporting Addiction Affected Families Effectively

NCT03412669 | Completed

• 1 other identifier: SAN_SAFE_2016
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Burden in addiction-affected families is a huge problem (well over 100 million family members worldwide are affected by substance use of a relative), largely unrecognised and untreated. Affected family members (AFMs) are vulnerable to physical and mental ill-health, reduced quality of relationships in the family, and family violence. In India, the burden of alcohol use is increasing: attitudes regarding alcohol use and alcohol availability, consumption patterns, age of drinking onset, levels of heavy drinking and alcohol-related problems, are all changing for the worse. These changes to levels of alcohol consumption and problems will have caused a corresponding increase in the prevalence of AFMs, although they are largely a hidden group. Yet, despite clear evidence of the burden of alcohol use on families, there is a lack of adequate support and targeted services for them. The objective of our study is to examine the preliminary effectiveness, feasibility and acceptability of Supporting Addiction Affected Families Effectively (SAFE) versus Enhanced Usual Care (EUC) in improving clinical outcomes. Methods: Our study is a parallel arm Pilot Randomised Controlled Trial of a psychosocial intervention for family members affected by a relative's alcohol use, in Goa, India. 100 AFMs will be recruited by referrals from community gatekeepers and professionals, and self-referrals resulting from media coverage of the study and and word-of-mouth publicity. Those who consent will be allocated in a 1:1 ratio to receive either SAFE (counselling) or EUC (information sheet). SAFE will be delivered by lay counsellors over 5 sessions spread across a month and a half, and EUC will consist of an information sheet on alcohol use, its nature, impact and treatment. The primary outcome is mean difference in 'symptoms' scores assessed by the Symptom Rating Test (at 3 months). Secondary outcomes are mean differences in 'coping' scores assessed by the Coping Questionnaire, 'impact' scores assessed by the Family Member Impact Questionnaire, and 'support' scores assessed by the Alcohol, Drugs and the Family Social Support Scale (at 3 months). The primary analyses will be intention-to-treat at the 3-month end-point. Discussion: Our study will aid the process of translational research, by adopting frameworks that have an established evidence base, and implementing these frameworks in a culturally appropriate manner to newer underserved populations.

Conditions

Addiction

Keywords

Addiction affected family members; Counselling; Psychosocial intervention; Low and Middle Income Countries; India; Pilot Randomised Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Symptom Rating Test

  * Full Scale Name: Symptom Rating Test (Kellner \& Sheffield, 1973; Orford et al, 2005, 2010a). * Construct: This scale measures physical and psychological symptoms; conceptualized as 'Strain' within the Stress-Strain-Coping-Support Model (the model underlying the SAFE project - Orford et al, 2010b). * Total scale range: Total symptom score (min.= 0 max.= 60) * Sub scale range: Total psychological symptom score (min.= 0 max.= 36) and total physical symptom score (min.= 0 max.= 24) * Higher values represent higher symptoms - i.e. worse outcomes * Subscales are combined by summing.

  3 months

Secondary Outcomes (3)

• Coping Questionnaire

  3 months

• Family Member Impact Questionnaire

  3 months

• Alcohol, Drugs and the Family Social Support Scale

  3 months

Other Outcomes (1)

• Domestic Violence Questionnaire

  3 months

Study Arms (2)

Counselling

EXPERIMENTAL

Supporting Addiction Affected Families Effectively is a contextually adapted version of the 5-Step Method, a psychosocial intervention based on the principles of the Stress-Strain-Coping-Support model. The intervention is manualised, and is delivered by lay counsellors over 5 sessions at a weekly basis. The 5 steps (covered in the 5 steps) include: 1) Exploring stresses and strains, 2) Providing relevant information, 3) Exploring and discussing coping behaviours, 4) Exploring and enhancing social support, and 5) Exploring additional needs, and further sources of help. The intervention is delivered in settings based on convenience of the participant: which might be a place outside the home (e.g. field office, neighbour's home), or the participant's home.

Other: Supporting Addiction Affected Families Effectively

Enhanced Usual Care

ACTIVE COMPARATOR

In the study setting, usual care for affected family members is no care at all, as detection rates of stress/strain in affected family members are extremely low. Hence, Enhanced Usual Care for the control group consists of a minimal intervention, namely a leaflet. The leaflet focuses on the burden that affected family members experience in relation to a relative who drinks alcohol, and on various informal and formal sources of support that are available in the local community.

Other: Enhanced Usual Care

Interventions

Supporting Addiction Affected Families Effectively OTHER

Counselling

Counselling

Enhanced Usual Care OTHER

Information sheet

Enhanced Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age (18 years of age and above).
• Family member reports that the relative's drinking has been a major source of distress (to themselves or to others, in the family or outside) in the previous six months.
• Family member and the relative who has been consuming alcohol have been living in the same house at some point in the previous six months, or had regular contact.
• Family member is able to understand and speak any of the local vernacular languages (Konkani, Marathi, Hindi) or English.
• Family member does not have substance use-related problems.
• Family member does not have a severe physical or mental health problem that requires urgent treatment and/ or may interfere with participation in the program.
• Family member is a resident of the catchment area for the duration of the program.

You may not qualify if:

• Age (less than 18 years of age).
• Family member does not report that the relative's drinking has been a major source of distress (to themselves or to others, in the family or outside) in the previous six months.
• Family member and the relative who has been consuming alcohol have not been living in the same house at some point in the previous six months, or not had regular contact.
• Family member is not able to understand and speak any of the local vernacular languages (Konkani, Marathi, Hindi) or English.
• Family member has substance use-related problems.
• Family member has a severe physical or mental health problem that requires urgent treatment and/ or may interfere with participation in the program.
• Family member is not a resident of the catchment area for the duration of the program.

Sponsors & Collaborators

• Sangath: lead
• Wellcome Trust: collaborator

Study Sites (1)

Sangath

Porvorim, Goa, India

Location

MeSH Terms

Conditions

Behavior, Addictive

Condition Hierarchy (Ancestors)

Compulsive Behavior; Impulsive Behavior; Behavior

Study Officials

• Urvita Bhatia, MSc

  Sangath

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2018
• First Posted: January 26, 2018
• Study Start: May 8, 2016
• Primary Completion: November 30, 2016
• Study Completion: November 30, 2016
• Last Updated: May 2, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)