Condition category
Mental and Behavioural Disorders
Date applied
30/06/2016
Date assigned
21/09/2016
Last edited
21/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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.

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. Miss Margiad Elen Williams (public)
margiad.williams@bangor.ac.uk
2. Professor Judy Hutchings (scientific)

Trial website

N/A

Contact information

Type

Public

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
01248 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

Not provided at time of registration

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 below 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

Sponsor information

Organisation

Bangor University

Sponsor details

School of Psychology
Brigantia Building
College Road
Bangor
LL57 2AS
United Kingdom

Sponsor type

University/education

Website

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

Publication citations

Additional files

Editorial Notes