Children's mental health Mental and Behavioural Disorders
Conditions
Interventions
We plan an 18-month internal pilot randomised controlled trial (RCT) leading to a definitive 30-month RCT. Participants will be randomly allocated to Incredible Years (IY) or service as usual (SAU) ac
2 hours/ week) and/or IY-Toddler (12 weeks
2 hours/ week) dependent on level of need at data collection points 2 and 3. Control parents will receive services as usual.
Sponsors
University of York
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Child Primary Outcome (primary outcome for the study): 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) Parent Primary Outcome (key secondary outcome for the study): 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) | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 06/02/2020: Child Secondary Outcomes: 1. Behaviour – measured at 18-month follow-up using the Strengths and Difficulties Questionnaire (SDQ) 2. Attachment – using the CARE Index (measured at baseline and 2, 9, and 18 months post-baseline) 3. Cognitive development – measured at 18-month follow-up using parent report PedsQL Infant Scale 4. Health (quality of life) – measured at 18-month follow-up using parent report PedsQL Infant Scale 5. Service use –using parent report: Client Service Receipt Inventory (CSRI) (measured at baseline and 2, 9, and 18 months post-baseline) Parent Secondary Outcomes: 1. Carer-child attachment/interaction – measured at 18-month follow-up using parent report Maternal Postnatal Attachment Scale (MPAS) and/or Paternal Postnatal Attachment Scale (PPAS) 2. Parenting skill – using parent report Parent Sense of Competence (PSOC) (measured at baseline and 2, 9 and 18 months post-baseline) 3. Health Related Quality of Life (HRQoL) –using parent report EQ5D5L (measured at baseline and 2, 9 and 18 months post-baseline) 4. Service use – using parent report CSRI (measured at baseline and 2, 9, and 18 months post-baseline) 5. Demographics – using bespoke parent report demographics form capturing key information on age, ethnicity, religion, income, marital status, parent/co-parent education (measured at baseline and 2, 9 and 18 months post-baseline, with a shorter version used for all appointments except baseline). Measures for the economic evaluation: 1. Service use – using parent report CSRI (measured at baseline and 2, 9 and 18 months post-baseline) Measures for the process evaluation: 1. Facilitators’ adherence to core components – standard, weekly-completed, self-rated Incredible Years checklists 2. Implementation fidelity – researcher-rated Parent Programme Implementation Checklist (PPIC), which comprises indices for adherence, dose/exposure, quality of delivery and participant responsiveness, observ | — |
Countries
England, United Kingdom
Contacts
Public ContactSarah Blower
Outcome results
None listed