Condition category
Pregnancy and Childbirth
Date applied
17/09/2010
Date assigned
06/10/2010
Last edited
02/06/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://incredible-years-wales-research.bangor.ac.uk/

Contact information

Type

Scientific

Primary contact

Mrs Catrin Jones

ORCID ID

Contact details

Incredible Years Centre
Nantlle Building
Normal site
Bangor University
Bangor
LL57 2PZ
United Kingdom
+44 (0)1248 382651
pspae8@bangor.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

3; 10/WNo01/40

Study information

Scientific title

Prevention of conduct problems and anti-social behaviour in at risk infants: a small scale cluster, non-randomised trial

Acronym

IY Infant evaluation

Study hypothesis

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

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

Study design

Small scale cluster non-randomised trial using a stepped wedge design

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact Mrs Catrin Jones [pspae8@bangor.ac.uk] to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

21/09/2010

Overall trial end date

01/11/2012

Reason abandoned

Eligibility

Participant 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

Participant type

Healthy volunteer

Age group

Mixed

Gender

Both

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)

Participant 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.

Recruitment start date

21/09/2010

Recruitment end date

01/11/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Incredible Years Centre
Bangor
LL57 2PZ
United Kingdom

Sponsor information

Organisation

Bangor University (UK)

Sponsor details

c/o Oliver Turnbull
Head of School of Psychology
Brigantia Building
Bangor
LL57 2AS
United Kingdom
+44 (0)1248 383670
o.turnbull@bangor.ac.uk

Sponsor type

University/education

Website

http://www.bangor.ac.uk/

Funders

Funder type

Other

Funder name

European Social Funded Knowledge Economy Skills Scholarship (KESS) managed by

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Bangor University (UK)

Alternative name(s)

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

United Kingdom

Funder name

Incredible Years Wales charity (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes