Beyond primary outcomes in effectiveness research: A platform-study update and some reflections on directions for the CTN.

This presentation begins with an update on the CTN-0014 platform study, “Mediators and Moderators of BSFT for Adolescent Drug Use.” Previous research on BSFT, a family therapy based on structural family systems theory, has focused mainly on outcomes, with little attention to how the treatment actually works or for whom it might be the most beneficial. Using protocol CTN-0014 as a platform, the authors tested hypotheses about mediators and moderators of BSFT. The study found within-treatment associations between BSFT fidelity and outcome, with minority participants accounting for most of these associations. Associations between BSFT fidelity and observed family change also varied by ethnicity, with significant correlations appearing for minority families, but not whites. Unfortunately, the study also found that the modal quality of BSFT was considerably less than ideal — most of the cases reviewed by the investigators featured BSFT that was considered less than adequate. As fidelity is at the heart of good psychosocial intervention trials, good treatment effectiveness research, and replicable dissemination, the fact that establishing and maintaining high fidelity was very difficult in this trial warrants further examination.

The presentation ends with reflections on future directions for the CTN, including ways to elevate the study of mechanisms, focus on moderators at both the case and organizational level, study therapist development to maximize fidelity, and have centrally organized but independently conducted trials across sites.

Related protocols: CTN-0014, CTN-0014-A-1