ISRCTN15330120
Suspended
未知
Rethinking Strategies for Positive Newborn Screening Result (NBS+) Delivery (ReSPoND): A process evaluation of co-designing interventions to minimise impact on parental emotional well-being and stress
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Genetic screening in newborn
- Sponsor
- City, University of London
- Enrollment
- 160
- Status
- Suspended
- Last Updated
- 3 years ago
Overview
Brief Summary
2019 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/31508239 protocol (added 12/09/2019) 2020 Other publications in https://pubmed.ncbi.nlm.nih.gov/33004391/ Health professionals' experiences (added 07/10/2020) 2021 Other publications in https://pubmed.ncbi.nlm.nih.gov/34452966/ Process evaluation (added 01/09/2021) 2020 Interim results article in https://pubmed.ncbi.nlm.nih.gov/33310815/ Assessment of current practice (added 31/10/2022) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35881727/ (added 31/10/2022)
Investigators
Eligibility Criteria
Inclusion Criteria
- •Parents of children who have received a NBS\+ result in the previous 3\-12 months including true positives, false positives and children who later have a cystic fibrosis screen positive, inconclusive diagnosis (CFSPID). This time frame has been chosen as the focus for this research based on feedback from parents of children who have previously received a NBS\+ result. It has also been demonstrated that positive NBS can impact on child\-parent relationships during the first year of life.
- •Health professionals:
- •1\. Staff employed in NBS laboratories and involved in the processing of NBS\+ results
- •2\. Staff who have been involved in communicating NBS\+ results to parents in the last 6 months.
Exclusion Criteria
- •1\. Parent of children who have received a negative NBS result
- •2\. Parents of children with co\-morbidities that are likely to influence their perception of receiving the positive NBS result
- •3\. Parents whose baby has died prior to being approached to be involved in the study
- •4\. Inability of parents to understand and give informed consent
- •5\. Parents whose recruitment is contraindicated on psychosocial grounds (identified by their health visitor or specialist nurse)
- •Health professionals:
- •1\. Staff who have not been involved in communicating positive NBS results to parents in the last 6 months
- •2\. Staff who have personal experience of receiving a positive NBS result
Outcomes
Primary Outcomes
Not specified
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