Condition category
Mental and Behavioural Disorders
Date applied
18/01/2017
Date assigned
06/02/2017
Last edited
13/03/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims:
Autism spectrum disorder (ASD) is a condition that affects social interaction, communication, interests and behaviour that occurs in around 1% of children. Previous research has shown that the majority of children aged 4-8 years diagnosed with ASD display concerning emotions and behaviours. These include hyperactivity, difficulties with attention, defiance and aggression, and fears and worries.

Parents have reported that these difficulties lead to further impairment and additional family stress, therefore effective intervention is needed. There is emerging evidence that parenting programmes that work on aspects of behaviour could be effective in reducing concerning emotions and behaviours in young children with ASD. The aim of the study is to develop and evaluate a group-based programme for parents (ASTAR B) that could be delivered in the NHS and private and voluntary sectors. ASTAR B will be evaluated against a second group-based programmes, ASTAR A.

Who can participate?
Parents/carers of a child aged 4-8 years diagnosed with ASD.

What does the study involve?
The ASTAR Study compares two newly developed group programmes for parents of young children with autism spectrum disorders (ASD). Both programmes (ASTAR A and ASTAR B) consist of 12 weekly group sessions. They aim to extend parents’ understanding of ASD and associated difficulties but each intervention has a different focus. ASTAR A includes information about ASD, supporting parents to look after themselves, and promoting use of existing supports and resources. ASTAR B focusses on emotional and behavioural problems and discussing ways of managing these.

The ASTAR Study consists of two phases. During the first phase, the study procedures and the group programmes are tested to check that they are acceptable to families. Following this, ASTAR A is directly compared to ASTAR B. During the second phase, families are randomly allocated to one of the two group programmes.

To help develop study procedures and programmes that are acceptable to families, parent and therapist views on the procedures and programmes are obtained and an additional eight to ten parents who declined to participate in the study are interviewed. To examine the effects of the programmes on children and parents, families complete study assessments before and after the programme. The study assessments include observing how parents and children interact. Measures of child mental health and behaviour in home and education settings, parental confidence to manage concerning emotions and behaviour, parenting practices, parental stress, parental wellbeing and parental quality-of-life are also obtained. Information on participating families’ service use and costs are sought and the cost-effectiveness of the programmes is examined.

What are the possible benefits and risks of participating?
Parents may benefit from the opportunity to take part in a group programme and receive tailored support provided by the therapists during the home visits. Families also benefit from have a detailed assessment about their child completed by trained professionals. We do not anticipate any risks to participating families.

Where is the study run from?
The study is run in South East London by a team of researchers at King’s College London and therapists at the South London and Maudsley (SLaM) NHS Foundation Trust.

When is study starting and how long is it expected to run for?
February 2017 to April 2019

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Dr Melanie Palmer
ASTAR@kcl.ac.uk

Trial website

http://iamhealthkcl.net/research-studies/treatment/

Contact information

Type

Public

Primary contact

Dr Melanie Palmer

ORCID ID

Contact details

Department of Child and Adolescent Psychiatry
Institute of Psychiatry
Psychology & Neuroscience (IoPPN)
King's College London
PO Box 85
De Crespigny Park
London
SE5 8AF
United Kingdom
+44 207 848 5260
ASTAR@kcl.ac.uk

Type

Scientific

Additional contact

Prof Tony Charman

ORCID ID

Contact details

Department of Psychology
Institute of Psychiatry
Psychology & Neuroscience (IoPPN)
King's College London
Box PO77
De Crespigny Park
London
SE5 8AF
United Kingdom
+44 207 848 5038
tony.charman@kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1.2

Study information

Scientific title

Can a parent-focussed intervention reduce mental health problems in young children with ASD? The Autism Spectrum Treatment and Resilience (ASTAR) feasibility and pilot trial

Acronym

ASTAR

Study hypothesis

The aim of this study is to test whether a group-based parent training intervention specifically focusing on the identification and management of co-existing emotional and behavioural problems in young children with autism spectrum disorder (ASD) will be associated with their subsequent improvement and which other domains, e.g., parent stress, may be affected by more generic supportive interventions.

Ethics approval

NHS Camden and Kings Cross Research Ethics Committee, 18/11/2016, ref: 16/LO/1769

Study design

Part 1: Single-centre feasibility study
Part 2: Pilot randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Treatment

Patient information sheet

Please use the contact details to request a participant information sheet.

Condition

Emotional and behavioural problems displayed by 4-8 year old children with autism spectrum disorder

Intervention

The study consists of two phases: a feasibility phase and a pilot randomised controlled trial.

Feasibility phase:
After initial contact, consent is obtained and the baseline assessments are administered. Eligible participants then receive either ASTAR A or ASTAR B. There is a staggered approach to intervention delivery during the feasibility phase. Participating families receive either ASTAR A or ASTAR B depending on when they are referred into the study and which intervention is due to be delivered next. In addition, eligible families who did not take up the offer of the intervention are interviewed (N~8-10).

Both ASTAR A and ASTAR B use existing strategies from recognised interventions that are designed to help families with children with ASD. They extend parents’ understanding of ASD and associated difficulties but each intervention has a different focus. Content for both ASTAR A and ASTAR B will be modified for differentiated delivery to groups held with parents of children with ASD who are minimally verbal.

ASTAR A consists of supportive parent groups. It extends parents’ understanding of ASD and associated difficulties and include psychoeducation, supporting parents to look after themselves, and promoting use of existing supports and resources. ASTAR A involves 12 weekly 120-minute group sessions and two 60-minute home visits to support generalisation and individualisation for each family.

ASTAR B, the behavioural parent training intervention, also extends parents’ understanding of ASD and associated difficulties. It focuses on emotional and behavioural problems and has a strong behavioural emphasis on ways of managing these problems. ASTAR B involves 12 weekly 120-minute group sessions and two 60-minute home visits to support generalisation and individualisation for each family.

Post-intervention assessments are administered immediately after the end of the intervention (approximately 13-15 weeks after baseline). A sub-sample of families are interviewed to obtain their views of the research procedures and the interventions. In addition, therapist views of the research procedures and the interventions are also be sought.

Once the feasibility phase is complete and any necessary modifications made to the research procedures or intervention manuals, the pilot RCT is conducted. Any changes to the protocol will be approved by the REC and the record on the trial registry will be updated.

Pilot RCT:
After initial contact, consent is obtained and the baseline assessments are administered. Eligible participants are then randomly allocated to receive either ASTAR A or ASTAR B. Randomisation is done by group (~12 families randomised 1:1 into ASTAR A or ASTAR B, stratified by verbal ability level (minimally verbal vs. single words or greater) and by site (locality). Both ASTAR A and ASTAR B use existing strategies from recognised interventions that are designed to help families with children with ASD. They extend parents’ understanding of ASD and associated difficulties but each intervention has a different focus. Content for both ASTAR A and ASTAR B is modified for differentiated delivery to groups held with parents of children with ASD who are minimally verbal.

ASTAR A consists of supportive parent groups. It extends parents’ understanding of ASD and associated difficulties and include psychoeducation, supporting parents to look after themselves, and promoting use of existing supports and resources. ASTAR A involves 12 weekly 120-minute group sessions and two 60-minute home visits to support generalisation and individualisation for each family.

ASTAR B, the behavioural parent training intervention, also extends parents’ understanding of ASD and associated difficulties. It focuses on emotional and behavioural problems and has a strong behavioural emphasis on ways of managing these problems.

Post-intervention assessments are administered immediately after the end of the intervention (at approximately 13-15 weeks after baseline). If staff resources allow, a reduced set of measures are repeated at a follow-up around 12 weeks after post-intervention (approximately 25-27 weeks after baseline).

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Child behaviour observed during a parent-child interaction is measured at baseline and 13-15 weeks (post-intervention). This measure is new and is first tested for reliability and validity during the feasibility phase of this study. If it is shown not to be reliable and valid then teacher ABC (see below) will be the primary outcome.

Secondary outcome measures

For the feasibility phase and pilot RCT phase:
1. Teacher-rated child mental health and behaviour is measured using the Aberrant Behaviour Checklist (ABC)-Irritability and Hyperactivity/Non-compliance sub scales and the Assessment of Concerning Behaviour (ACB) at baseline and 13-15 weeks
2. Parent-rated child mental health and behaviour is measured using the ABC-Irritability and Hyperactivity/Non-compliance subscales, the ACB, the Home Situations Questionnaire-ASD, and the Preschool Anxiety Scale Revised at baseline and 13-15 weeks
3. Parent identified child problems is measured using Parent-Defined Target Symptoms at baseline and 13-15 weeks
4. Global clinical improvement in children from baseline is measured using clinician-rated Clinical Global Impressions-Improvement Scale at 13-15 weeks
5. Parent behaviour observed during a parent-child interaction is measured at baseline and 13-15 weeks
6. Parental expressed emotion is measured using the Autism-Specific Five Minute Speech Sample at baseline and 13-15 weeks
7. Parenting stress is measured using the Autism Parenting Stress Index at baseline and 13-15 weeks
8. Parenting competence/self-efficacy is measured using the Brief Parental Self Efficacy Scale and the Child Adjustment and Parent Efficacy Scale-Developmental Disability-Parent Efficacy sub scale at baseline and 13-15 weeks
9. Health-related parental quality-of-life is measured using the EQ-5D 5L at baseline and 13-15 weeks
10. Parental wellbeing is measured using the Warwick-Edinburgh Mental Wellbeing Scale and the Office of National Statistics Personal Wellbeing questions at baseline and 13-15 weeks
11. Parenting practices is measured using the Parenting Scale-Short version at baseline and 13-15 weeks
12. Service use and costs is measured using a Client Service Receipt Inventory developed for the study at baseline and 13-15 weeks
13. Adverse effects from baseline is measured using deterioration in primary and secondary outcome measures

Overall trial start date

01/06/2016

Overall trial end date

30/04/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. Parents/carers of children aged 4-8 years with a clinical diagnosis of ASD
2. Sufficient spoken English to participate in the assessments/interventions
3. Agreeing that their family doctor can be informed of their involvement in the study

Participant type

Mixed

Age group

Mixed

Gender

Both

Target number of participants

N=24 for feasibility study and N=60 (30/arm) for pilot RCT. In addition, interviews with ~10 families who declined the offer of the intervention will be conducted during the feasibility phase.

Participant exclusion criteria

1. Current participation in another parent training programme
2. Children with epilepsy poorly controlled by medication (more than weekly seizures)
3. Severe hearing or visual impairment in parent or child
4. Current severe parental psychiatric disorder
5. Active safeguarding concerns
6. For the pilot RCT, participation in the ASTAR feasibility study

Recruitment start date

07/02/2017

Recruitment end date

30/09/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

King's College London, Institute of Psychiatry, Psychology & Neuroscience (IoPPN)
PO Box 85, 16 De Crespigny Park
London
SE5 8AF
United Kingdom

Trial participating centre

Croydon Child and Adolescent Mental Health Services (South London and Maudsley NHS Foundation Trust)
Christopher Wren House, 113 High Street
Croydon
CR0 1QG
United Kingdom

Sponsor information

Organisation

Institute of Psychiatry, Psychology & Neuroscience (IoPPN), King's College London and South London and Maudsley NHS Foundation Trust

Sponsor details

Joint Research & Development Office
Institute of Psychiatry
Psychology & Neuroscience (IoPPN) and South London and Maudsley NHS Foundation Trust
PO05
De Crespigny Park
King's College London
London
SE5 8AF
United Kingdom
+44 20 7836 5454
slam-ioppn.research@kcl.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The study protocol and pilot RCT findings will be published. Other publications will be confirmed at a later date.

IPD Sharing plan:
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

01/05/2020

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

13/03/2017: Internal review.