Improving New Parents' Understanding of a Trial. The INPUT Study.

Not Applicable

• Conditions: nderstanding of clinical trials; Anxiety about clinical trials; Willingness to participate in clinical trials; Understanding of clinical trials; Public Health - Health promotion/education

• Registration Number: ACTRN12613001381774
• Lead Sponsor: Professor William Odita Tarnow-Mordi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-12-17
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Eligible participants must fulfill at least one of the following criteria:
(i) Pregnant women in the antenatal ward with a potential preterm pregnancy and their partners,
(ii) Parents whose babies are in the NICU or Special Care Nursery receiving CPAP or less.

Women aged 18 - 49 years
Men aged >18 years

Exclusion Criteria

People whose primary language is other than English (LOTE)
Children and/or young people (ie. <18 years)
People who clinicians identify as unsuitable for the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Parents' level of understanding of the hypothetical clinical trial will be measured using a previously validated questionnaire (Porteri et al, 2009) adapted for use in parents of newborn infants. [During completion of a 30 minute face to face questionnaire immediately after reading the information leaflet.]

Secondary Outcome Measures

Name	Time	Method
Parents' level of anxiety will be measured using the previously validated State­ Trait Anxiety Inventory State (Spielberger et al, 1977; O'Brien et al, 2013). [During completion of a 30 minute face to face questionnaire immediately after reading the information leaflet.];Parents' willingness to participate in the hypothetical clinical trial will be measured on a five part Likert Scale ranging from very unlikely to participate to very likely to participate.[During completion of a 30 minute face to face questionnaire immediately after reading the information leaflet.]