Evaluation of the Incredible Years Infant programme
| ISRCTN | ISRCTN62055412 | 
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN62055412 | 
| Secondary identifying numbers | 3; 10/WNo01/40 | 
- Submission date
 - 17/09/2010
 - Registration date
 - 06/10/2010
 - Last edited
 - 04/10/2017
 
- Recruitment status
 - No longer recruiting
 - Overall study status
 - Completed
 - Condition category
 - Pregnancy and Childbirth
 
            
            Prospectively registered
        
    
                    
                        
    
        
            
            Protocol
        
    
                    
                        
    
        
            
            Statistical analysis plan
        
    
                    
                        
    
        
            
            Results
        
    
                    
                        
    
        
            
            Individual participant data
        
    
                    
                        
    
                    
                    Plain English summary of protocol
Not provided at time of registration
Contact information
                                            Mrs Catrin Jones
Scientific
                                        Scientific
                                                Incredible Years Centre
Nantlle Building
Normal site
Bangor University
Bangor
LL57 2PZ
United Kingdom
                                                
| Phone | +44 (0)1248 382651 | 
|---|---|
| pspae8@bangor.ac.uk | 
Study information
| Study design | Small scale cluster non-randomised trial using a stepped wedge design | 
|---|---|
| Primary study design | Interventional | 
| Secondary study design | Non randomised study | 
| Study setting(s) | Other | 
| Study type | Prevention | 
| Participant information sheet | Not available in web format, please use contact Mrs Catrin Jones [pspae8@bangor.ac.uk] to request a patient information sheet | 
| Scientific title | Prevention of conduct problems and anti-social behaviour in at risk infants: a small scale cluster, non-randomised trial | 
| Study acronym | IY Infant evaluation | 
| Study objectives | The main hypothesis is that attendance at an Incredible Years Infant group for 8 weeks will increase parental confidence and encourage positive parenting as measured using the coded observed interactions and expressed emotion at the 6- and 12-month post baseline follow-up visit. Other areas of interest in this study are the level of appropriate stimulation provided to the infants, which could encourage the developmental quotient of the infants. Parental mental well-being may be improved through the supportive environment and encouragement of participants to link up with other group members for support both during and after the group. The emphasis on safety issues may raise parents' awareness of the potential hazards and action needed to prevent unintentional injury in the home. As the results of the toddler study suggests maternal mental well-being may increase following attendance on the infant programme.  | 
| Ethics approval(s) | 1. Bangor University School of Psychology Ethics Committee, 16/07/2010 2. NHS North Wales Research Ethics Committee (REC), 19/07/2010, ref: 10/WNo01/40 3. NHS R&D Internal review panel, 05/08/2010  | 
| Health condition(s) or problem(s) studied | Infant development, carer well being | 
| Intervention | The Incredible Years Infant programme (Webster-Stratton, 2008) is delivered in a group format to parents and their babies over 8 x 2 hour sessions. The programme is aimed at encouraging parent understanding of parenting and infant development in the first 12 months. | 
| Intervention type | Other | 
| Primary outcome measure | Video recorded coding of interactions between the primary caregiver and their child at the 6- and 12-month post -baseline follow-up visit. | 
| Secondary outcome measures | 1. Assessment of the home environment: provision of suitable environment and safety awareness of the parent 2. Assessment of maternal mental health 3. Child developmental assessment All outcomes will be measured at baseline, 6 months post-baseline and 12 months post-baseline.  | 
| Overall study start date | 21/09/2010 | 
| Completion date | 01/11/2012 | 
Eligibility
| Participant type(s) | Healthy volunteer | 
|---|---|
| Age group | Mixed | 
| Sex | All | 
| Target number of participants | 78 families in total. We aim to recruit families on a 2:1 ratio (Intervention:control) in the research (54 Intervention and 24 control) | 
| Key inclusion criteria | 1. Participants must have babies that are 2 - 16 weeks old at the baseline visits and are deemed by their Health visitor to live on a low income 2. Intervention families must agree to attend the 8-week programme with their baby  | 
| Key exclusion criteria | 1. Parents that have previously attended a Baby parenting programme are excluded from the research 2. Families that live beyond North and Mid Wales are excluded as Group leaders will need to attend weekly supervisory meetings and families will need home visits by the researcher. One Intervention cluster will provide parent-completed measures collected by their group leader.  | 
| Date of first enrolment | 21/09/2010 | 
| Date of final enrolment | 01/11/2012 | 
Locations
Countries of recruitment
- United Kingdom
 - Wales
 
Study participating centre
                                            Incredible Years Centre
                                        
                                        
                                            
                                            Bangor
LL57 2PZ
United Kingdom
                                    LL57 2PZ
United Kingdom
Sponsor information
                                            Bangor University (UK)
University/education
                                        University/education
                                                c/o Oliver Turnbull
Head of School of Psychology
Brigantia Building
Bangor
LL57 2AS
Wales
United Kingdom
                                                
| Phone | +44 (0)1248 383670 | 
|---|---|
| o.turnbull@bangor.ac.uk | |
| Website | http://www.bangor.ac.uk/ | 
| https://ror.org/006jb1a24 | 
Funders
Funder type
Other
                                                European Social Funded Knowledge Economy Skills Scholarship (KESS) managed by
                                            
                                            No information available
                                                Bangor University (UK)
                                                
Private sector organisation / Universities (academic only)
                                            Private sector organisation / Universities (academic only)
- Location
 - United Kingdom
 
                                                Incredible Years Wales charity (UK)
                                            
                                            No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No | 
| IPD sharing plan summary | Not provided at time of registration | 
| Publication and dissemination plan | Not provided at time of registration | 
| IPD sharing plan | 
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? | 
|---|---|---|---|---|---|
| Results article | results | 15/07/2016 | Yes | No | 
Editorial Notes
04/10/2017: Publication reference added.