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Objective: to elaborate the conceptual and theoretical-empirical structure, based on the application of Roy’s Adaptation model, to guide the development of a controlled clinical trial aimed at assessing the effectiveness of a nursing intervention program to promote the adaptation of family caregivers with caregiver role strain. Method: theoretical study. The conceptual structure was developed in three phases: development of a comprehensive understanding of the conceptual model, literature review and construction of the conceptual and theoretical-empirical structure itself. Results: the application process demonstrated its consistency in the design of an intervention program for family caregivers of chronic patients, to be tested in a controlled clinical trial. The indicators of adaptation were the reduced score on the caregiver tension scale and the increased perception of wellbeing and quality of life. Conclusion: Roy’s model serves as an important guide for nursing research intended to test nursing interventions that favor the wellbeing of family caregivers. DESCRIPTORS: Caregivers. Nursing. Nursing theory. Chronic disease. MODELO DE ADAPTAÇÃO EM UM ENSAIO CLÍNICO CONTROLADO COM CUIDADORES FAMILIARES DE PESSOAS COM DOENÇAS CRÔNICAS