Close
Participant Identification
The study population is parents of young children with ID concerned about their behaviour living in the community in 4 different areas. We have not included children with profound ID as we deem that the intervention is not suitable to their needs and children with mild ID are also excluded as their needs are likely to be met by other available interventions. Eligible participants will be identified by the community paediatric and child and adolescent mental health teams in each of the 4 areas. Health or social care professionals will identify eligible participants through new referrals or existing cases. Identification will involve reviewing or screening identifiable personal information of participants by members of the normal clinical team. If needed, i.e recruitment is not picking up sufficiently, we shall open Patient Identification Centres in areas adjacent to the primary sites. The professional time to be spent on participant identification has been costed through NHS support costs and a SOP will further detail the precise process at each site. All participants interested in taking part will complete an Expression of Interest form which will be then passed on to the researchers. Flyers about the study will be put up at local parent groups, nurseries or special schools if available and GP practices.
Study Setting
Study participants will be recruited from a wide variety of services within the participating centres in North and South London, North East (Newcastle and surrounding areas) and North West (Blackpool and surrounding areas) England. Services will include NHS settings, e.g. Child Development Teams which are the main point of referrals for children suspected with developmental delay and potentially with challenging behaviour; Child and Adolescent Mental Health Services; education (nursery/preschool) and third sector e.g. caregiver groups. Children are assessed through the Healthy Child Programme, a universal resource for 0-5 year olds which aims to identify families that require more support and children at risk of "poor outcomes".
Screening
Once a parent has expressed an interest in the study and in meeting the researchers, they will need to consent to the screening process which is that the child meets inclusion/exclusion criteria. In particular, the parent administered ABAS about the child's adaptive behaviour/level of functioning and to confirm that the child has had challenging behaviours in the past 2 to 6 months continually, i.e. such behaviours are present several times a week.
Screening for eligibility is conducted using parent rated child level of functional abilities for screening at baseline (Adaptive Behavior Assessment System-III (ABAS; 37); Parent/Primary Caregiver Form: Ages 0-5). This measure will help to decide whether a child's level of intellectual ability falls within our inclusion criteria.
If the screening outcome is that the child's adaptive functioning does not reveal disability or reveals mild or profound levels of learning disability, then the family will be thanked for their cooperation by a letter in the post and given an information sheet detailing a number of resources. No further contact will be made. However, where the child fulfils the adaptive function range, the baseline assessment (assuming consent is given) will take place, following which the participant will be randomised.
Informed Consent Procedure
The patient information sheet will be handed out by the professionals at identification of eligible participants or sent via post to identified potentially eligible participants. Parents of a child with moderate to severe ID who are worried about or have had concerns about his/her behaviour will be approached by a member of clinical staff/clinical study officer, given an introduction to the study and the study Patient Information Sheet and asked to complete an expression of interest form. The EPICC-ID trial does not involve children that may be able to consent for themselves.
Informed consent, is two stage: first it will be obtained by the researchers from the person who has parental responsibility for the child to complete the screening measures. At two weeks, and if the child remains eligible, the researchers will then consent the parent for the full study. Prior to any study assessments taking place, the parent will provide written or (audio-recorded) verbal informed consent. If the child is ineligible, the parent will be thanked for their time and given the reasons for this. All participants will be free to withdraw at any time from the study/intervention without giving a reason or affecting further treatment. After meeting with the RA, all parents will have at least 24 hours to decide whether to enter the study. The researchers will be inducted in the study procedures including how to obtain informed consent and will be asked to complete the online GCP course as part of their induction. A copy of the signed Informed Consent form will be given to the participant. The original signed form will be retained at the study site and a copy placed in the medical notes.
Inclusion Criteria
1. Parents 18 years or over; 2. Child aged 30-59 months at identification; 3. Child has moderate to severe intellectual disability (parent reported ABAS General Adaptive Functioning 20-69; 37); 4. Written informed consent by parent/caregiver; 5. Reports of challenging behaviour over a 6- month period but no less than 2 months. Final eligibility for entry into the study will be confirmed by the research team who will confirm eligibility using the ABAS score.
Exclusion Criteria
1. Child has mild, profound or no LD on parent reported ABAS; 2. Parent/carer has insufficient English language to complete study questionnaires; 3. Another sibling is taking part in a parenting study.
Randomisation
Randomisation lists (one per site) will be prepared by the PRIMENT Clinical Trials Unit (to maintain statistician blinding) using 3:2 allocation ratio (intervention and TAU vs TAU) and will be uploaded to the external internet based randomisation and data management site 'Sealed Envelope' prior to the study commencing. Each case will be assigned a study number and treatment allocation emailed separately to the treatment centre therapists. Eligible participants will be allocated online to the next available treatment code in the relevant randomisation list. Randomisation will be stratified by centre and level of Learning Difficulties (moderate and severe) and blocking will be used with random block sizes.
Blinding
As this is a study of a psycho-social intervention, the parents will be aware in which arm they have been allocated. We shall make every effort to ensure that the RAs remain blind to arm allocation and parents will be reminded that they must not disclose any details about their treatment prior to appointments. The research assistants will be based in separate departments to those organizing and delivering the treatment ensuring masking to participant arm allocation.
Allocation Concealment
The Research Assistants will enter the results of the baseline assessment on a web-based system. Parents and therapists will be given information about allocation status and arrangements will be made to commence the group sessions. Researchers will be housed separately from staff involved in delivery of level 4 SSTP. The therapists will not treat any family allocated to TAU.
