Plain English Summary
Background and study aims
The Incredible Years Parenting Programme is a group-based programme developed to support parents, children and teachers. Its aim is to help autistic children to develop emotional and social skills, language skills and help them build relationships with other people. This study aims to pilot the programme in three children’s services in North and Mid Wales. An initial pilot showed promising results with a group of nine parents however there was no control comparison group (that is a similar group that have not been on the programme). Researchers now want to run a more rigorous pilot of the programme.
Who can participate?
Parents of children aged 3-8 years with a diagnosis, or strongly suspected diagnosis, of Autism.
What does the study involve?
Families are recruited through Specialist Children’s Services (SCS) and/or Child and Adolescent Mental Health Services (CAMHS). SCS and CAMHS staff are provided with a checklist of eligibility criteria to help them identify eligible families. Once an eligible family is identified, staff introduce the project and ask if they would be interested in learning more about it. If parents agree, they are asked to complete a Note of Interest form and to give their permission for the form to be forwarded to the research team. On receipt of the form, a member of the research team contacts the parent to arrange a home visit to provide further details about the study and obtain informed consent. Once consent is obtained, the researcher asks the parent to complete a number of questionnaires and a 10-minute observation that is filmed. During the observation session, parents are asked to play with their child as they normally would. Once all initial data (known as baseline) has been collected from all participating families, they are randomly allocated to either the IY Autism intervention or a wait-list control condition. Families in the intervention condition start the IY Autism parent programme in immediately, whilst control families are offered the programme nine months later. Every family is required to complete the baseline (first) data collection visit and a 6-month follow-up visit, which follows the same pattern as the initial visit. Families in the intervention condition are asked to complete a 12-month and an 18-month follow-up visit, whichis the same as the other data collection visits. Group leaders and families in the intervention condition will also be interviewed to gain their views on delivering/attending the programme.
What are the possible benefits and risks of participating?
By participating in the study there is an opportunity for parents to get support for their child’s behaviour. This is the first rigorous evaluation of this programme, however evaluations of other similar programmes have shown improvements in child behaviour, parental mental health, and positive parenting skills. All participants will be given access to the programme, although for some participants this will be after the 6-month follow-up data collection point rather than immediately. There are no obvious risks to participants.
Where is the study run from?
Four Specialist Children’s Services/ Child and Adolescent Mental Health Services in Wales.
When is the study starting and how long is it expected to run for?
June 2016 to August 2018
Who is funding the study?
Autistica (UK)
Who is the main contact?
1. Dr Margiad Elen Williams (public)
margiad.williams@bangor.ac.uk
2. Professor Judy Hutchings (scientific)
Trial website
Contact information
Type
Public
Primary contact
Dr 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
Type
Scientific
Additional contact
Prof Judy Hutchings
ORCID ID
Contact details
Centre for Evidence Based Early Intervention
Nantlle Building
Normal Site
Bangor University
Bangor
LL57 2PZ
United Kingdom
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A pilot randomised controlled trial of the Incredible Years® Autistic Spectrum and Language Delays parent programme
Acronym
PALACES
Study hypothesis
Aim is to pilot the IY Autism parent programme in three children’s services in Wales. The primary objectives are to determine whether:
1. It is possible to recruit and randomise to IY parent training versus wait-list control
2. Group facilitators are able to deliver the programme with fidelity
3. Parents engage with programme at the intended level
4. Retention remains high at every data collection time points
5. Parents report good levels of satisfaction with the intervention
Secondary objectives include:
1. Evaluating the effectiveness of the IY Autism parent programme versus wait-list control
2. Explore the costs of delivering the IY Autism parent programme, service use by parents/ children, and any reported improvement in parents’ quality of life
Ethics approval
1. School of Psychology Ethics Committee, Bangor University, 04/07/2016, 2016-15768
2. Betsi Cadwaladr University Health Board Wales Research Ethics Committee 5, 26/07/2016, 16/WA/0224. Ethics amendment for inclusion of qualitative interviews: Betsi Cadwaladr University Health Board Wales Research Ethics Committee 5, 29/03/2017, ref: 16/WA/0224/AM01
Study design
Randomised controlled trial with waiting-list control group
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Autism Spectrum Disorder
Intervention
The IY Autism and Language Delays programme is a group-based intervention consisting of 12–16 sessions (Webster-Stratton, 2015). It is offered to parents of children (aged 2-8) on the Autism spectrum or with language delays. The aim is to promote children’s emotional regulation, social competence, language skills, school readiness, and relationships with others. The programme is delivered in weekly, two-hour sessions. The families are randomised to two conditions: either the intervention condition (they receive the programme immediately) or the wait-list condition (they will be offered the intervention after the 6-month data collection visit).
Intervention type
Behavioural
Phase
Drug names
Primary outcome measures
The externalizing subscale of the Child Behaviour Checklist, measured at baseline, 6-months, 12-months, and 18-months (all time points)
Secondary outcome measures
1. Family Demographics (Family Characteristics), measured at baseline only
2. The Arnold-O’Leary Parenting Scale (Parenting Skills), measured at all time points
3. The Beck Depression Inventory II (Parental Depression), measured at all time points
4. Parenting Stress Index-Short Form (Parental Stress), measured at all time points
5. Social Communication Questionnaire (Child Autistic Symptoms), measured at all time points;
6. The Vineland Adaptive Behaviour Scales (Child Adaptive Behaviour), measured at baseline, 12 months, and 18 months
7. Family APGAR (Family Functioning), measured at all time points
8. Strengths and Difficulties Questionnaire (Sibling Behaviour), measured at all time points
9. Client Service Receipt Inventory (Family Service Use), measured at all time points
10. EQ-5D (Parent Quality of Life), measured at all time points
11. Observation of parent-child interaction (Parent and Child Behaviour), measured at all time points
All time points: baseline, 6 months, 12 months, and 18 months
Overall trial start date
01/06/2016
Overall trial end date
31/08/2018
Reason abandoned
Eligibility
Participant inclusion criteria
1. Parent/caregiver of child aged 3-8 years
2. Child with diagnosis, or strongly suspected diagnosis, of autism
3. Parent/carer speaks good English and/or Welsh
4. Parent/carer consents to take part in research
Participant type
Mixed
Age group
Mixed
Gender
Both
Target number of participants
72 parents and children
Participant exclusion criteria
1. Parent/carer attending other parent programme during intervention phase
2. Family is in crisis (e.g. child at risk of residential placement)
3. Child is in foster care without a long-term plan in that placement
4. Child is on child protection register; Refusal of consent to take part in research
Recruitment start date
01/09/2016
Recruitment end date
31/12/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Child and Adolescent Mental Health Service
Talarfon
Holyhead Road
Bangor
Gwynedd
Wales
LL57 2PZ
United Kingdom
Trial participating centre
Child and Adolescent Mental Health Service
Powys
Wales
SY16 1EG
United Kingdom
Trial participating centre
Child and Adolescent Mental Health Service
Conwy
Wales
LL30 1YE
United Kingdom
Trial participating centre
Child and Adolescent Mental Health Service
Flintshire/Wrexham
Wales
-
United Kingdom
Funders
Funder type
Charity
Funder name
Autistica
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
1. Study protocol and main study findings will be published
2. Other papers to be confirmed at a later date
Intention to publish date
Participant level data
To be made available at a later date
Results - basic reporting
Publication summary
2017 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/28209607