Profound and multiple learning disabilities Mental and Behavioural Disorders
Conditions
Interventions
The trial design is a cluster-randomised controlled trial with an internal pilot comparing the Intensive Interaction with care as usual. Trial participants are 3-25-year-old children and young people
Sponsors
University of Kent
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 09/12/2025: Educational settings: 1. Special Educational Needs and Disabilities (SEND) educational settings or mainstream educational settings with SEND units around Great Britain 2. At least five children and young people meeting the eligibility criteria 3. Capacity and willingness to agree to the requirements of participation outlined in a memorandum of understanding, which will ask them to confirm that they have the capacity and willingness to release staff to receive training; to deliver the intervention as intended with those children and young people participating in the trial; and to complete the outcome measures. Children and young people: 1. Attends an educational setting taking part in the trial 2. Have PMLD 3. Parent/guardian willing to give consent/act as a consultee for the child or young person 4. Parent/guardian willing to complete outcome measures 5. Child or young person is expected to remain at the setting for the duration of the trial Note: there are no specific inclusion/exclusion related to age. Previous inclusion criteria: Educational settings: 1. Special Educational Needs and Disabilities (SEND) educational settings or mainstream educational settings with SEND units around Great Britain 2. At least five children and young people meeting the eligibility criteria 3. Capacity and willingness to agree to the requirements of participation outlined in a memorandum of understanding, which will ask them to confirm that they have the capacity and willingness to release staff to receive training; to deliver the intervention as intended with those children and young people participating in the trial; and to complete the outcome measures. Children and young people: 1. Attends an educational setting taking part in the trial 2. Have PMLD 3. Parent/guardian willing to give consent/act as a consultee for the child or young person 4. Parent/guardian willing to attend II training 5. Parent/guardian willing to continue with the intervention at home 6. Parent/guardian willing to complete outcome measures 7. Child or young person is expected to remain at the setting for the duration of the trial Note: there are no specific inclusion/exclusion related to age.
Exclusion criteria
Exclusion criteria: Educational settings: 1. Setting unable to fulfil the requirements of the MOU 2. Currently deliver weekly or more frequent II 3. Staff have recently been formally trained in II 4. Insufficient eligible children and young people Children and young people: 1. Currently receiving weekly or more frequent II from II-trained staff within their educational setting 2. Have a degenerative condition or dementia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Communication skills measured using the Communication Complexity Scale (CCS) at baseline, 32 and 52 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| All secondary outcome measures will be collected at baseline, 32 and 52 weeks post-randomisation: 1. Cognitive development, communication, social and environmental interaction measured using Routes for Learning 2. Changes to educational care assessed through reviews of Education Plans 3. Behaviour problems measured using the Behaviour Problems Inventory (BPI-S) 4. Quality of life measured using the Quality of Life-Profound Multiple Disabilities, Mood Interest and Pleasure Questionnaire, Child Health Utility 9D, EQ-5D-Y 5. Parental well-being measured using the Parenting sense of competence scale, Warwick-Edinburgh Mental Well-being Scale, The Carer Experience Scale 6. Health care, social care and educational support service use measured using a bespoke instrument | — |
Countries
England, Scotland, United Kingdom, Wales
Contacts
Public ContactKerry;Katie Bell;Carlisle
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Outcome results
None listed