Does a delayed intervention study design address community concerns with randomization? The Padres Informados, Jovenes Preparados trial

Randomization is an important procedure for causal inference. However, community partners are often concerned that some community participants do not receive a potentially beneficial intervention. An alternative to the traditional randomized controlled trial (RCT) design that is often recommended for participatory studies is the delayed intervention study design. This design was used in the Padres Informados, Jovenes Preparados (PIJP), a Community-Based Participatory Research (CBPR) RCT assessing a parenting intervention to promote positive youth development to reduce smoking and subtance use among Latino youth. To assess if a delayed intervention design serves the community purpose of assuring access to the PIJP intervention (9 months after recruitment), we compared attendance rates between the intervention and control groups for the first 6 sites where PIJP was delivered. Parent attendance rates were recorded by facilitators. High participation was defined as attending 75% or more of the sessions. Descriptive statistics were calculated and crude estimates were compared using t-test and Chi-square tests. Participants in intervention and control groups had similar demographic characteristics at baseline. Participants in the intervention group attended on average 1.4 more sessions compared to participants in the control group (4.6±3.0 vs 3.2±3.0 respectively, p<0.001). High participation rates were 52.6% in the intervention and 32.5% in the control groups (p=0.001). Likely due to the time lag between recruitment and the delayed intervention participants were less able to attend the program. Alternative study designs should to be considered to succesfully address the needs of community participants.