Methods of recruiting adolescents with psychiatric and substance use disorders for a clinical trial.

A lack of research on effective ways of recruiting adolescents with co-occurring psychiatric and substance use disorders has contributed to the paucity of clinical trials and significant research gaps in such youths. Development of feasible and effective methods of recruitment is also critical to trial performance, as poor recruitment can lead to prohibitive costs, inadequate statistical power, and reduced scientific value of clinical trials. This article reports on the recruiting strategies for a 16-week, multi-site trial of osmotic-release methylphenidate combined with cognitive-behavioral therapy in adolescents with co-occurring attention deficit hyperactivity disorder and substance use disorder (protocol CTN-0028). A multifaceted recruiting strategy was employed that targeted multiple referral sources, used incentives, involved numerous staff members, emphasized the therapeutic alliance during prescreening, and utilized data to modify strategies based on results. Overall, 303 adolescents were randomized from 1,333 total referrals across 11 participating community treatment providers (CTPs). Results found that existing treatment program sources, including treatment program staff, social services, the juvenile justice system, and mental health clinics, provided a majority of referrals for prescreening and randomization. These results support the feasibility of recruiting dually-diagnosed adolescents using a multifaceted approach involving the entire study team.

Related protocols: CTN-0028