Essential considerations in developing attention control groups in behavioral research

Abstract

Attention control groups strengthen randomized controlled trials of behavioral interventions, but researchers need to give careful consideration to the attention control activities. A comparative effectiveness research framework provides an ideal opportunity for an attention control group as a supplement to standard care, so participants potentially receive benefit regardless of group assignment. The anticipated benefit of the control condition must be independent of the study outcome. Resources needed for attention control activities need to be carefully considered and ethical considerations carefully weighed. In this paper we address nine considerations for the design and implementation of attention control groups: (1) ensure attention control activities are not associated with the outcome; (2) avoid contamination of the intervention or control group; (3) design comparable control and intervention activities; (4) ensure researcher training to adequately administer both treatment arms; (5) design control activities to be interesting and acceptable to participants; (6) evaluate attention control activities; (7) consider additional resources needed to implement attention control activities; (8) quantifying the effects of attention control and intervention groups; and (9) ethical considerations with attention control groups. Examples from the literature and ongoing research are presented. Careful planning for the attention control group is as important as for the intervention group. Researchers can use the considerations presented here to assist in planning for the best attention control group for their study.

The Implementation and Evaluation of the South African Adaptation of the JOBS Program

“…A final limitation, particularly relevant to intervention studies in behavioral research, may be that much time has been spent with the experimental group, therefore, the results of this study can be attributed to the attention they received during the program. A comparative framework should be considered to provide an opportunity for the control group to receive equal attention (Aycock et al, 2018).…”

Osteoarthritis physical activity care pathway (OA-PCP): results of a feasibility trial

“…Despite the lack of change in PA metrics, participants reported clinically meaningful improvements in pain and function [51]. This could be due to the attention provided by the PA coach [52] or a Hawthorne effect [53]. The mean change in pain and function could also be a reflection of substantial changes in PA that were made by some patients.…”

Attention control group activities and perceived benefit in a trial of a behavioral intervention for older adults

“…This provides valuable information when comparing the attention control group results to the intervention group results. These compared results allowed us to more confidently interpret that the intervention did improve participants’ perception of benefit beyond the general benefit of increased attention, than if we had compared the intervention group to a waitlist control group (Aycock et al, ). For full results comparing the attention control group to the intervention group in terms of number and length of visits and perception of benefit, please see Szanton et al, .…”

“…One strategy for addressing comparison challenges in behavioral interventions is to provide control group study participants with attention control visits. In an attention control group, participants receive social attention equivalent in dose and timing to that provided by the intervention (Aycock, Hayat, Helvig, Dunbar, & Clark, ). Attention and interpersonal interactions alone may influence depression, pain, anxiety, and other health outcomes (Popp & Schneider, ; Stice, Burton, Bearman, & Rhode, ; Hedman et al, ; Seers, Crichton, Tutton, Smith, & Saunders, ).…”