Enhancing Social and Emotional Health in the Early Years

Not Applicable

Completed

• Conditions: Children's mental health; Mental and Behavioural Disorders

• Registration Number: ISRCTN11079129
• Lead Sponsor: niversity of York

Brief Summary

2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/30573493 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35377882/ (added 05/04/2022) 2021 Interim results article in https://doi.org/10.1007/s10826-021-01991-7 pilot trial results (added 11/05/2022) 2022 Other publications in https://pubmed.ncbi.nlm.nih.gov/35739551/ economic evaluation (added 24/06/2022) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35700307/ (added 05/06/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-11
• Study Completion: 2020-06-30
• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 341

Inclusion Criteria

1. Have the main parental responsibility for a child <8 weeks at initial engagement
2. Be willing to participate in the research
3. Be willing to be randomised and, if allocated to intervention, be able to receive Incredible Years services offered
4. Not be enrolled on another group parent programme at sign-up

Exclusion Criteria

1. The child has obvious or diagnosed organic or child developmental difficulties
2. Do not have the main parental responsibility for a child <8 weeks at initial engagement
3. Are not willing to participate in the research
4. Are not willing to be randomised and, if allocated to intervention, to receive Incredible Years services offered
5. Are enrolled on another group parent programme at sign-up

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Child Primary Outcome (primary outcome for the study):<br>Social and emotional wellbeing – to establish effectiveness at each and all Incredible Years dose levels, using parent report Ages & Stages Questionnaire – Social Emotional (ASQ:SE-2) (measured at baseline and 2, 9 and 18 months post-baseline)<br><br>Parent Primary Outcome (key secondary outcome for the study):<br>Depression – to establish effectiveness at each and all Incredible Years dose levels, using the parent report Patient Health Questionnaire (PHQ-9) (measured at baseline and 2, 9, and 18 months post-baseline)