Aims
To explore the efficacy and cost-effectiveness of ADVANCE to reduce IPV by men in treatment for substance use + substance use TAU compared to substance use TAU only.
Lessons learnt from the feasibility randomised controlled trial for work package 5 [and subsequently work package 4(ii)]
Due to the low eligibility rate (7%) of men approached in waiting rooms in WP4(i), substance use treatment staff should identify and screen men. Evaluating ADVANCE based on (ex)-partners’ outcomes was not feasible, as just 26% were recruited. Our review highlighted similar difficulties in other trials. The primary outcome should be IPV perpetration by men. To recruit more women, researchers rather than ISS workers make the first contact with (ex)-partners and tell them about the trial, with a subsequent call from ISS for all women. Facilitators rather than keyworkers deliver weekly coaching calls to build and maintain therapeutic alliance throughout ADVANCE. Finally, a ‘champion’ should be identified as the key point of contact at each service to streamline communication with the research team.
Trial design, sample size and primary outcome
A parallel-group individual RCT on a 2 : 1 basis to the intervention arm: 378 men randomly allocated to receive the ADVANCE group intervention + TAU (n = 252) or TAU only (n = 126). Self-reported IPV perpetration by men in substance use treatment using the Abusive Behaviour Inventory (ABI) – partner form (perpetration) in the previous 4 months at 12 months post randomisation would have been the primary outcome.166 Incremental cost-effectiveness and cost–utility analysis of the intervention over and above TAU was to be undertaken. A mixed-methods nested process evaluation was planned to understand the intervention’s functioning.
Results
The UK government imposed a lockdown on 16 March 2020 due to COVID-19. No participants had been recruited when the trial was paused on 17 March 2020 and later stopped due to group delivery not being possible. ADVANCE was then adapted for digitally supported delivery [WP3(ii)] and the feasibility of its delivery evaluated [WP4(ii)].