Negative effects on family functioning from psychosocial treatments: a recommendation for expanded safety monitoring.

Whereas biomedical products are required to be tested for safety with respect to vulnerable organ systems, psychosocial treatments are not required to be tested for safety with respect to vulnerable social systems such as the family. This article provides some evidence for the need to document the potential negative effects of psychosocial treatments on family-level outcomes. Three randomized controlled trials are reviewed in which independent ratings or self-reports of family functioning were measured. Each of the 3 studies compared the efficacy of a family and a nonfamily treatment. Totally unexpectedly, the nonfamily treatment in each of the 3 trials demonstrated significant declines in family functioning. The authors suggest that psychosocial treatments with vulnerable populations have the potential to produce negative side effects on families. Therefore, it is important to conduct further research to determine whether safety studies should be required for psychosocial treatments.