The Preliminary Evaluation of Supporting Addiction Affected Families Effectively

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

Interventions

OTHER

Supporting Addiction Affected Families Effectively

Counselling

OTHER

Enhanced Usual Care

Information sheet

Sponsors & Collaborators

• Wellcome Trust

  collaborator OTHER

• Sangath

  lead OTHER

Principal Investigators

• Urvita Bhatia, MSc · Sangath

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-05-08

Primary Completion

2016-11-30

Completion

2016-11-30

Countries

• India