Emotional and behavioural problems displayed by 4-8 year old children with autism spectrum disorder. Mental and Behavioural Disorders Emotional and behavioural problems displayed by 4-8 year old children with autism spectrum disorder.
Conditions
Interventions
Current interventions as of 23/10/2017:
Pilot RCT:
After initial contact, consent is obtained and the baseline assessments are administered. Eligible participants are t
Sponsors
Institute of Psychiatry, Psychology & Neuroscience (IoPPN), King's College London and South London and Maudsley NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 15/02/2019: Child behaviour that challenges observed during a structured researcher-child and parent-child interaction assessment is measured at baseline and 18-24 weeks after randomisation (post-intervention). The measure is new and the trialists first wanted to establish the reliability and validity of the measure. The change back to child behaviour that challenges was made prior to unblinding and any analyses being undertaken, after careful consideration about the primary aim of the intervention and the reliability of the developed measure. This change in primary outcome was approved by the ASTAR Trial Steering Committee on the 21/01/2019. Previous primary outcome measure from 23/10/2017 to 14/02/2019: Parent 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 an alternative primary outcome measure will be selected prior to analysis. Any change in primary outcome measures will be approved by the ASTAR Trial Steering Committee. Original primary outcome measure: 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
| Measure | Time frame |
|---|---|
| Current secondary outcome measures for the pilot RCT phase as of 15/02/2019: 1. Child compliance observed during the structured researcher-child and parent-child interaction assessment is measured at baseline and 18-24 weeks (post-intervention) 2. Parent behaviour observed during the structured researcher-child and parent-child interaction assessment is measured at baseline and 18-24 weeks (post-intervention) 3. 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 18-24 weeks (post-intervention) 4. 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 18-24 weeks (post-intervention) 5. Improvement in parent identified child problems is measured using Parent-Defined Target Symptoms at baseline and 18-24 weeks (post-intervention) 6. Global clinical improvement in children from baseline is measured using clinician-rated Clinical Global Impressions-Improvement Scale at 18-24 weeks (post-intervention) 7. Parenting stress is measured using the Autism Parenting Stress Index at baseline and 18-24 weeks (post-intervention) 8. Parenting competence/self-efficacy is measured using the Child Adjustment and Parent Efficacy Scale-Developmental Disability-Parent Efficacy sub scale at baseline and 18-24 weeks (post-intervention) 9. Health-related parental quality-of-life is measured using the EQ-5D 5L at baseline and 18-24 weeks (post-intervention) 10. Parental wellbeing is measured using the Short Warwick-Edinburgh Mental Wellbeing Scale and the Office of National Statistics Pe | — |
Countries
England, United Kingdom
Contacts
Public ContactMelanie Palmer
Outcome results
None listed