Related Experiment Video
Updated: Aug 18, 2026

A Familiarization Protocol Facilitates the Participation of Children with ASD in Electrophysiological Research
Published on: July 31, 2017
Participant-centered adaptations in caregiver trials: strategies for managing confounds
Linda Lindsey Davis1, Michael Weaver, Barbara Habermann
1School of Nursing, Duke University, Durham, NC 27210, USA. davis317@mc.duke.edu
Background:
Randomized trials have been criticized for being more protocol than participant-centered, with concerns raised about higher subject attrition and limited generalizability under controlled conditions. Informal caregivers are similar to other participants in community-based trials: many are unlikely to remain in a trial without procedural adaptations to meet some of their needs.
Purpose:
This article discusses design and statistical strategies for tracking potential confounds associated with 3 participant-centered adaptations that may be made in community-based caregiver trials: tailoring multi-component interventions, using interpersonal contacts for participant maintenance, and non-blinding of trial participants. The intent of the article is to initiate dialogue on the seldom-discussed issue of participant-centered adaptations in community-based trials.
Conclusions:
Participant-centered adaptations may reduce subject attrition and enhance generalizability, but protocol adaptation can compromise trial integrity. The challenge for investigators is to develop scientifically sound methods for tracking / controlling potential confounds associated with each adaptation.
Related Concept Videos
Strategies for Assessing and Addressing Confounding
Confounding can be addressed at both the design phase of a study and through analytical methods after data...
Modeling in Therapy
Participant Modeling
Participant modeling involves therapists demonstrating calm and effective behaviors in situations...
Blinding
Patient-centered Care
Blind Procedures