Evaluation of the Enhancing Parenting Skills (EPaS) 2014 intervention for parents of children with behaviour problems

Plain English Summary

Background and study aims
The Enhancing Parenting Skills (EPaS) 2014 programme is an 8 session course for professionals that work with children and families. It aims to improve the knowledge and ability of professionals in cases where the child has behavioural problems. This study was set up to determine as to whether the programme is effective in dealing with these problems. Previous studies have shown that participation in the programme does result in improvement in child behaviour. However, the number of families and health visitors that have taken part have been small so far. Here, we will recruit a larger sample of families and health visitors for the study.

Who can participate?
Parents of children aged 2.5 - 4 years who score within the clinical range on a child behaviour questionnaire (Eyberg Child Behaviour Inventory). Parents and children must speak Welsh and/or English.

What does the study involve?
We are recruiting health visitors to complete a 3-day training in the EPaS 2014 programme. Each health visitor finds two families from their caseload to participate in the study. Potential families are asked to complete a questionnaire about their child's behaviour and, if the child has a high Eyberg Child Behaviour Inventory score, are invited to participate in the study. A researcher then contacts the family to arrange a home visit to collect information for the trial (data collection). Families are given an information sheet to read and, if they are happy to take part, a consent sheet to sign. They are then asked to complete a number of questionnaires and a 30-minute observation session. During the observation session, the researcher observes the interaction between the parent and child whilst they are completing a play task chosen by the child. Following the initial data collection visit (known as baseline), families are randomly allocated to either the treatment group or a wait-list control group, ensuring that each health visitor has on treatment family and one control family. Treatment families complete the EPaS 2014 programme immediately, whilst control families are offered the programme 4-months later when the first follow-up data collection visits have been completed. Health visitors will complete a 3-day training in the EPaS 2014 programme (one day every month for 3 months) whilst working with their treatment family. Every family is required to complete the baseline data collection visit and a 4-month follow-up visit, which is the same as the initial visit. Treatment families are also asked to complete a 8-month follow-up visit, which is the same as the other data collection visits.

What are the possible benefits and risks of participating?
By participating in the study there is an opportunity to get support for their child's behaviour problems that has been shown to be effective in previous studies. All participants will be given access to the programme, although for some participants this will be after the second follow-up data collection point rather than at the beginning. There are no obvious risks to participants.

Where is the study run from?
Banger University (UK)

When is the study starting and how long is it expected to run for?
January 2014 to December 2016

Who is funding the study?
Bangor University (UK)

Who is the main contact?
Miss Margiad Williams
Margiad.Williams@bangor.ac.uk

Trial website

Type

Scientific

Primary contact

Miss Margiad Elen Williams

ORCID ID

Contact details

Centre for Evidence Based Early Intervention
Nantlle Building
Normal Site
Bangor University
Bangor
LL57 2PZ
United Kingdom
+44 (0)1248 383627
margiad.williams@bangor.ac.uk

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Scientific title

A randomised controlled trial of the Enhancing Parenting Skills (EPaS) 2014 intervention for parents of children with behaviour problem

Acronym

The EPaS 2014 Project

Study hypothesis

Aim to evaluate the EPaS 2014 one-to-one intervention, delivered by health visitors, for parents of children with behaviour problems.
The primary research question is: Does the EPaS 2014 intervention lead to reductions in children's behaviour problems?

Ethics approval

North Wales Betsi Cadwaladr University Health Board (BCUHB) Research Ethics Committee, 24/06/2014, ref: 14-WA-0187

Study design

Randomised controlled trial with waiting-list control group

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Home

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Conduct Disorder, child behaviour problems

Intervention

The families are randomised to two groups: one receives the intervention immediately and the other receives the intervention after a four-month waiting period.
The Enhancing Parenting Skills (EPaS) 2014 programme is a one-to-one intervention delivered by health visitors to parents of a child with behaviour problems. Training for health visitors includes assessment methods, case analysis, and intervention strategies. The intervention is delivered in weekly home visits for 10-12 weeks. Each health visitor will deliver the intervention to two families; one immediately and one after the 4-month follow-up assessment (wait-list control group). Intervention families will have three data collection points: baseline, 4 months and 8 months. Wait-list control families will only undertake two data collection points: baseline and 4-month follow-up.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Eyberg Child Behaviour Inventory (Child Behaviour) measured at baseline, 4-months, and 8-months

Secondary outcome measures

1. The Arnold-O'Leary Parenting Scale (Parenting Skills), measured at baseline, 4 months, and 8 months
2. The Beck Depression Inventory (Parental Depression), measured at baseline, 4 months, and 8 months
3. The Conners Abbreviated Parent-Teacher Questionnaire (Hyperactivity Symptoms), measured at baseline, 4 months, and 8 months
4. Direct observation of parent-child interaction (Parent and Child Behaviour), measured at baseline, 4 months, and 8 months
5. A demographic questionnaire (Family Characteristics), measured at baseline only
6. Peabody Picture Vocabulary Scale (Child Language), measured at baseline, 4 months, and 8 months

Overall trial start date

01/01/2014

Overall trial end date

31/12/2016

Reason abandoned (if study stopped)

Participant inclusion criteria

1. Parent of child aged 2.5 to 4 years
2. Child will be rated by health visitor as in clinical range for behaviour problems using the Eyberg Child Behaviour Inventory
3. Parent and child will speak either Welsh and/or English
4. Parent consents to participate, including being observed interacting with their child

Participant type

Mixed

Age group

Mixed

Gender

Both

Target number of participants

60 health visitors and 120 families

Total final enrolment

58

Participant exclusion criteria

1. Child is incorrect age
2. Child does not score in clinical range on the ECBI
3. Parent and child do not speak Welsh or English
4. Child has a clinical diagnosis such as ASD, ADHD, learning difficulties, etc.
5. Parent does not consent

Recruitment start date

01/07/2014

Recruitment end date

31/12/2015

Countries of recruitment

United Kingdom

Trial participating centre

Bangor University
Bangor
LL57 2PZ
United Kingdom

Organisation

Bangor University (UK)

Sponsor details

School of Psychology
Brigantia Bulding
College Road
Bangor
LL57 2DG
United Kingdom

Sponsor type

University/education

Website

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

Funder type

University/education

Funder name

Bangor University (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

Universities (academic only)

Location

United Kingdom

Publication and dissemination plan

The outcomes of the trial will be submitted for publication in a peer-reviewed journal and should be published by 31/12/2018.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Margiad Williams (margiad.williams@bangor.ac.uk). All data is anonymised and in SPSS databases. Data will be available until 31/12/2020.

Intention to publish date

31/12/2019

Participant level data

Available on request

Basic results (scientific)

See additional file (ISRCTN06867279_BasicResults_19Dec17)

Publication list

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25986699

Publication citations

• ISRCTN06867279_BasicResults_19Dec17.pdf Uploaded 22/01/2018

14/06/2019: The following changes were made to the trial record: 1. The intention to publish date was changed from 31/12/2018 to 31/12/2019. 2. The total final enrolment was added. 22/01/2018: The recruitment dates have been updated from 01/01/2014 - 31/12/2016 to 01/07/2014 - 31/12/2015. The ethics reference has been added. The publication and dissemination plans have been added. The participant level data sharing statement has been added. The basic results of this trial have been uploaded as an additional file.