Ensuring treatment fidelity in a multi-site behavioral intervention study: Implementing NIH behavior change consortium recommendations in the SMART trial

Sheri L. Robb, Debra S. Burns, Sharron L. Docherty, Joan E. Haase

Research output: Contribution to journalArticle

41 Scopus citations

Abstract

The Stories and Music for Adolescent/Young Adult Resilience during Transplant (SMART) study (R01NR008583; U10CA098543; U10CA095861) is an ongoing multi-site Children's Oncology Group randomized clinical trial testing the efficacy of a therapeutic music video intervention for adolescents/young adults (11-24 years of age) with cancer undergoing stem cell transplant. Treatment fidelity strategies from our trial are consistent with the National Institutes of Health (NIH) Behavior Change Consortium Treatment Fidelity Workgroup (BCC) recommendations and provide a successful working model for treatment fidelity implementation in a large, multi-site behavioral intervention study. In this paper, we summarize 20 specific treatment fidelity strategies used in the SMART trial and how these strategies correspond with NIH BCC recommendations in five specific areas: (1) study design, (2) training providers, (3) delivery of treatment, (4) receipt of treatment, and (5) enactment of treatment skills. Increased use and reporting of treatment fidelity procedures is essential in advancing the reliability and validity of behavioral intervention research. The SMART trial provides a strong model for the application of fidelity strategies to improve scientific findings and addresses the absence of published literature, illustrating the application of BCC recommendations in behavioral intervention studies.

Original languageEnglish (US)
Pages (from-to)1193-1201
Number of pages9
JournalPsycho-Oncology
Volume20
Issue number11
DOIs
StatePublished - Nov 1 2011

Keywords

  • behavioral intervention research
  • clinical trials
  • intervention integrity
  • quality assurance monitoring
  • treatment fidelity

ASJC Scopus subject areas

  • Oncology
  • Psychiatry and Mental health
  • Experimental and Cognitive Psychology

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