|
Stage
|
Feasibility RCT CSO funded
|
Bridging period NSPCC funded
|
NIHR funding/legal challenge to London randomisation
|
Definitive RCT with London site
|
End of recruitment
|
New end date with 2.5-year follow-up
|
|
Time
|
Dec 2011–May 2015
|
June 2015–Dec 2015
|
Jan 2015–28.08.2017
|
29.08.2017
|
31.7.21
|
29.02.2024
|
|
Randomisation condition
|
Consent > baseline > randomisation
|
Randomisation > consent > baseline
|
Consent > randomisation > baseline
|
|
Key challenges
|
Very high recruitment rate and delays to accessing services
|
Waiting lists due to teams treating non-RCT families
|
Potential for bias to be introduced through post-randomisation baseline assessment—necessary to comply with judicial requirements
|
