Support for families (parents/carers) of children with intellectual disability Mental and Behavioural Disorders
Conditions
Interventions
Families will be randomised using an allocation 1:1 ratio to E-PAtS or Usual Practice (UP). Randomisation will occur using randomly permuted blocks and will be developed by the study statistician. In
Sponsors
University of Warwick
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Family units with at least one child with an ID aged 18 months-5 years 2. The identified child with ID meets the following: 2.1. An administrative label of ID (learning disability/learning difficulties in UK terminology) AND 2.2. Has a standard score on the Vineland Adaptive Behaviour Scales composite score of <80 3. At least one parent/caregiver is available to attend the E-PAtS intervention 4. Parent/caregivers who are to participate in the study are = 18 years old 5. Parent/caregivers who are to participate in the study have a level of English language enabling (verbal) completion of outcome measures
Exclusion criteria
Exclusion criteria: 1. The identified child with ID is in a 24-h residential placement 2. The identified child with ID is in a foster placement due to end before the 12-month post-randomisation follow up data collection point 3. The primary caregiver is enrolled at baseline in a group or individually-delivered parenting programme outside of the study 4. The primary caregiver is enrolled in a programme of personal psychological therapeutic support at baseline 5. Any parent in the family has already participated in an E-PAtS group 6. There are current child protection concerns relating to the identified child with ID that have been identified by professionals/services and indicated to programme facilitators or their host organisation at the point of recruitment 7. The family are recognised to be in a state of current crisis/a score of 8+ on the 10-point Brief Family Distress Scale
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measured at baseline, 3 months post-randomisation and 12 months post-randomisation. The method of data collection will be dependent on the preference of the participant at the screening/recruitment interview. Data will therefore be collected face-to-face, over the telephone or by post. All data collection forms will be paper CRFs/questionnaires 1. The feasibility of recruiting eligible participants to the study and the most effective recruitment pathways to identify families of young children with ID 2. The feasibility of recruiting suitable providers and facilitators to run E-PAtS parenting groups 3. Recruitment rates, adherence to the intervention and retention rates 4. The views of providers and facilitators regarding delivering the intervention and study processes 5. The views of parents/caregivers regarding the intervention and study processes 6. The views of parents/caregivers regarding randomisation within the context of a RCT 7. Fidelity of implementation of the E-PAtS intervention through observation and participant/facilitator interviews 8. Usual practice in this setting and use of services/support in both groups 9. The feasibility of the outcome measures and whether there is preliminary evidence of differences on these measures between the intervention and control group 10. The feasibility of collecting resource use and health related quality of life data for parents and the child with ID to conduct health economic evaluation 11. The views of parents/caregivers regarding the acceptability of using their routinely collected data within the context of a RCT | — |
Secondary
| Measure | Time frame |
|---|---|
| A range of established outcome measures, proposed to test the intervention in a main trial, will be measured. All outcome measures will be assessed on paper CRFs over the telephone, face to face or by post (participant preference) at baseline, 3 months post randomisation and 12 months post randomisation, with the exception of VABS which will only be measured at baseline and 12 months post randomisation. The outcome measures include: 1. Parent impact secondary outcomes (measures for both parents, irrespective of whether they attended the E-PAtS intervention): 2.1. Parental psychological well-being, measured using the Warwick-Edinburgh Mental Well-Being Scale 2.2. Parental anxiety and depression, measured using the Hospital Anxiety and Depression scale 2.3. Parent health-related quality of life, measured using EQ-5D-5L 2.4. Parental situational coping approaches (i.e., coping strategies related to the care of their child with ID), measured using the Brief COPE 2. Secondary outcomes – child with ID: 2.1. Behavioural and emotional problems, and language development, measured using the Child Behavior Checklist (CBCL) for children 1.5-5 years of age including the language development survey supplement 2.2. Adaptive skills and behaviour problems of the child with ID measured with the Vineland Adaptive Behaviour Scales (VABS – 3rd edition). The VABS has an overall standardised Adaptive Composite, and a further three standardised scores for key domains measured across the age range for this study: communication, socialisation, and daily living skills. Parents will also report on “maladaptive” behaviours in the VABS 2.3. Child health-related quality of life, measured using the Paediatric Quality of Life InventoryTM Version 4.0 Generic Core Scales 3. Secondary outcomes – family and family systems: 3.1. P | — |
Countries
England, United Kingdom
Outcome results
None listed