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DOI: 10.1055/s-0035-1549639
Psychological impact on parents by participating in the Pre-POINT study
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.