SOSA: Stay one step ahead implementation study

Not Applicable

Completed

• Conditions: nintentional injuries; Injury, Occupational Diseases, Poisoning

• Registration Number: ISRCTN31210493
• Lead Sponsor: niversity of Nottingham

Brief Summary

2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33067223/ protocol (added 20/10/2020) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/36720631/ (added 02/02/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-16
• Study Completion: 2021-04-30
• Last Update Posted: 13 February 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 797

Inclusion Criteria

1. Parent participants
1.1. Parents of children residing in the 4 SSBC wards and the 5 control wards
1.2. Parents must be aged 18 years or over
1.3. Children must be 2 to 7 months old when study invites are sent
1.4. Children must be living in their usual place of residence (i.e. not in temporary accommodation such as a refuge or foster care)
1.5. Parents must return a completed baseline questionnaire
1.6. Eligibility criteria for parent interviews
1.6.1. Parents taking part in the CBA
1.6.2. Able to provide written informed consent or verbal informed consent over the telephone to take part in the interview
1.6.3. Parents must have had either a 9-12 month review or a 2-2.5 year Healthy Child Programme review (hereafter referred to as child health review).
1.7. Observations of 9-12 month and 2-2.5 year child health reviews:
1.7.1. Parents taking part in the CBA
1.7.2. Able to provide written informed consent to have their child’s review observed
1.7.3. Parents whose child’s review is undertaken in English
1.8. Economic evaluation
1.8.1. Parents taking part in the CBA
1.8.2. Able to provide written informed consent to extract data from their child’s medical records

2. Service provider participants:
Interviews:
2.1. Service providers (health visiting teams, family mentors and early years staff (e.g. children’s centre managers and staff)) in SSBC and control wards who provide written informed consent or verbal informed consent over the telephone for interviews.
2.2. For the interviews with providers who conduct 9-12 month or 2-2.5 year child health reviews the provider must have experience of conducting 9-12 month or 2-2.5 year child health reviews since the start of the SSBC programme.
Observations:
2.3. Service providers (e.g. health visiting teams) in SSBC and control wards who provide written informed consent for observations of 9-12 month or 2-2.5 year child health reviews

Exclusion Criteria

Parents:
1.1. Not residing in SSBC or control wards
1.2. Aged under 18 years
1.3. Children not aged 2-7 months old when study invites sent
1.4. Not returning completed baseline home safety questionnaire
1.5. Not providing written informed consent or verbal informed consent over the telephone for interviews, written informed consent for observations of child health reviews or for extraction of data from medical records
1.6 Parents whose child’s review is not undertaken in English

Service providers:
2. Service providers not providing written informed consent or verbal informed consent over the telephone for interviews or written informed consent for observations of 9-12 month or 2-2.5 year child health reviews

Study & Design

• Study Type: Interventional
• Study Design: Not specified