Diabetologie und Stoffwechsel 2015; 10 - P133
DOI: 10.1055/s-0035-1549639

Psychological impact on parents by participating in the Pre-POINT study

M Bassy 1, K Lange 1, AG Ziegler 2, 3, G Klingensmith 4, E Schober 5, R Roth 6, PJ Bingley 7, M Rottenkolber 8, A Theil 9, C Peplow 2, A Eugster 9, G Eisenbarth 4, R Puff 2, J Hasford 8, P Achenbach 2 E Bonifacio 9 for the Pre-POINT study group
  • 1Medizinische Hochschule Hannover, Medizinische Psychologie, Hannover, Germany
  • 2Institute of Diabetes Research, Helmholtz Zentrum München, und Forschergruppe Diabetes, Klinikum rechts der Isar, Technische Universität München, München, Germany
  • 3Forschergruppe Diabetes e.V., Neuherberg, Germany
  • 4Barbara Davis Center for Childhood Diabetes, University of Colorado, School of Medicine, Aurora, United States
  • 5Department of Pediatrics, Medical University of Vienna, Wien, Austria
  • 6Institut für Diabetesforschung, Helmholtz Zentrum München, München, Germany
  • 7School of Clinical Sciences, University of Bristol, Bristol, United Kingdom
  • 8Institute for Medical Information Sciences, Biometry, and Epidemiology, Ludwig-Maximilians-Universität, München, Germany
  • 9DFG Center for Regenerative Therapies Dresden, Faculty of Medicine, Technische Universität Dresden, Dresden, Germany

Introduction: The Primary Oral INsulin Trial (Pre-POINT) study offered an immunization-like treatment to prevent type 1 diabetes in children (2 – 7yrs.) with high diabetes risk. This sub-study assessed the psychological impact on parents by participating in the Pre-POINT study.

Method: Parents completed questionnaires on parental distress prior to and at 3 and 9 months of participation. The questionnaire included a 6-item short form of the State-Trait Anxiety Inventory (STAI) to assess parents' anxiety about their child's risk of developing diabetes and a 6-item wellbeing-questionnaire (WBQ). In addition, 3 items assessed parents' satisfaction (high-low: 1 – 5) with study participation and recommendation of the study to a friend.

Results: Forty parents completed questionnaires at entry and 19 at 9 months follow-up. Moderate anxiety scores (min – max: 0 – 18) were observed at entry (9.51 ± 4.1) and these dissipated during participation (9 month scores, 6.53 ± 4.6; p = 0.016). The mean scores of depression (optimal wellbeing-depression: 0 – 18) were low at all three assessments (4.08 ± 1.9; 3.42 ± 1.8; 4.84 ± 1.7; p = 0.19). Furthermore, satisfaction with the decision to participate was high with no differences over time (1.79 ± 0.73; 1.78 ± 0.66; 1.79 ± 0.86). At 9 months, 89.5% of the participants would recommend the study participation to other families. Two participants withdrew consent after 3 and 6 months of treatment, respectively, because one family had difficulties attending the visits and the other felt that participation in the study would not help preventing type 1 diabetes.

Conclusion: No evidence for a negative psychological impact of study participation could be observed.