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Piloting, psychometric testing and feasibility studies of adapted DIALOG+ in people with mild to moderate learning disability

Improving quality of life and behaviour that challenges in people with mild to moderate intellectual disability through person-centred solution focused communication (ICONIC)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN11440256
Enrollment
502
Registered
2025-07-07
Start date
2025-08-07
Completion date
Unknown
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild to moderate intellectual disability Mental and Behavioural Disorders

Interventions

Current interventions as of 16/04/2026: An adapted version of DIALOG+ (a brief, low-cost solution-focused intervention that improves the therapeutic effectiveness of routine clinical meetings between

Sponsors

North East London NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: Current inclusion criteria as of 16/04/2026: WP1a: Service Users Inclusion Criteria: 1. Aged 18 years or over 2. Mild or moderate ID based on service records / clinical notes 3. Current history of behaviour that challenges (at least one incident of self-injurious behaviour, physical or verbal aggression, temper tantrums / outbursts, or damage to property in the last 3 months) 4. Living in any setting including the family home and supported living/residential home 5. Can provide informed verbal or written consent WP1b Psychometric Testing: Service Users Inclusion Criteria: 1. Aged 18 years or over 2. Mild or moderate ID based on service records / clinical notes 3. Under community ID services from the East London Foundation Trust - Updated 04/11/2025: from participating NHS trusts 4. Can provide informed verbal or written consent WP1b Comparison Testing: Service Users Inclusion Criteria: 1. Aged between 18 and 65 years 2. Living in the community and treated as out-patients by community psychiatric teams from participating NHS trusts 3. Have a primary diagnosis of a mental health issue 4. Can provide informed verbal or written consent WP2: Service Users Inclusion Criteria: 1. Aged 18 years or over 2. Mild or moderate ID based on service records / clinical notes 3. Current history of behaviour that challenges (at least one incident of self-injurious behaviour, physical or verbal aggression, temper tantrums / outbursts, or damage to property in the last 3 months) 4. Living in any setting including the family home and supported living/residential home 5. Can provide informed verbal or written consent WP3: Service Users Inclusion Criteria: 1. Aged 18 years or over 2. Mild or moderate ID based on service records / clinical notes 3. Current history of behaviour that challenges (at least one incident of self-injurious behaviour, physical or verbal aggression, temper tantrums / outbursts, or damage to property in the last 3 months) 4. Residing in supported living or residential care 5. Can provide informed verbal or written consent Previous inclusion criteria: WP1a 1. Service Users Inclusion Criteria: 1. Aged 18 or over 2. Mild or moderate ID based on service records / clinical notes 3. Current history of behaviour that challenges (at least one incident of self-injurious behaviour, physical aggression or damage to property in the last 3 months) 4. Living in any setting including the family home and supported living/residential home 5. Can provide informed verbal or written consent 2. Clinicians Inclusion Criteria: 1. Aged 18 or over 2. Currently working within a community ID service, intensive support team or in a local authority or social care organisation for people with ID 3. From any profession (e.g. psychology, nursing, speech and language therapy, psychiatry, social work), grade 4 and above with a minimum of six months experience working with people with ID 4. Consent to participation 3. Care Workers Inclusion Criteria: 1. Aged 18 or over 2. Have worked in the care home for at least three months 3. Provide at least one day of support per week to service users 4. Consent to participation WP1b 1. Service Users Inclusion Criteria: 1. Aged 18 or over 2. Mild or moderate ID based on service records / clinical notes 3. Under community ID services from the East London Foundation Trust - Updated 04/11/2025: from participating NHS trusts 4. Can provide informe

Exclusion criteria

Exclusion criteria: Current exclusion criteria as of 16/04/2026: WP1b Psychometric Testing: Service Users Exclusion Criteria: 1. Under 18 years of age 2. Severe ID based on service records/clinical notes 3. Not under community ID services from the East London Foundation Trust - Updated 04/11/2025: from participating NHS trusts 4. Unable to provide informed verbal or written consent WP1b Comparison Testing: 1. Under 18 years of age and over 66 years of age 2. Currently in an inpatient in a psychiatric hospital 3. Do not have a primary mental health diagnosis (e.g., substance misuse disorder) 4. Unable to provide informed verbal or written consent Previous exclusion criteria: WP1a 1. Service Users Exclusion Criteria: 1. Under 18 years of age 2. Severe ID based on service records / clinical notes 3. Likely to move out of borough within the next 3 months or at imminent risk of hospital admission 4. Unable to provide informed verbal or written consent 2. Clinicians Exclusion Criteria: 1. Under 18 years of age 2. Not currently working within a community ID service, intensive support team or in a local authority or social care organisation for people with ID 3. Below grade 4 and less than 6 months experience working with people with ID 4. Do not consent to participation 3. Care Workers Exclusion Criteria: 1. Under 18 years of age 2. Have worked in the care home for less than 3 months 3. Do not provide at least one day of support per week to service users 4. Do not consent to participation WP1b 1. Service Users Exclusion Criteria: 1. Under 18 years of age 2. Severe ID based on service records / clinical notes 3. Not under community ID services from the East London Foundation Trust - Updated 04/11/2025: from participating NHS trusts 4. Unable to provide informed verbal or written consent WP2 1. Service Users Exclusion Criteria: 1. Under 18 years of age 2. Severe ID based on service records / clinical notes 3. Already participating in WP3 or involved in another clinical trial 4. Likely to move out of borough within the next 6 months or at imminent risk of hospital admission 5. Unable to provide informed verbal or written consent 2. Clinicians Exclusion Criteria: 1. Under 18 years of age 2. Not currently working within a community ID service, intensive support team or in a local authority or social care organisation for people with ID 3. Below grade 4 and less than 6 months experience working with people with ID 4. Do not consent to participation 5. Have participated in other work packages 3. Participant Carers Exclusion Criteria: 1. Under 18 years of age 2. If a paid carer and have worked with the person for less than six months and/or do not know the person well and/or support the person on a regular basis 3. Do not consent to participation WP3 1. Service Users Exclusion Criteria: 1. Under 18 years of age 2. Severe ID based on service records / clinical notes 3. Already participating in WP2 or involved in another clinical trial 4. Likely to move out of the care home within the next six months or are at imminent risk of hospital admission 5. Unable to provide informed verbal or written consent 2. Care Homes Exclusion Criteria: 1. Not supported living or residential placements for service users with ID and/or not in the participating areas 2. Service manager does not agree for the

Design outcomes

Primary

MeasureTime frame
Current primary outcomes as of 16/04/2026: WP1a Piloting: 1. Acceptability of / feedback on the intervention is measured using semi-structured interviews / focus groups after 2-4 weeks. 2. Intervention implementation processes from the perspective of clinicians and care workers are assessed using the NoMAD questionnaire after 2-4 weeks. WP1b Psychometric Testing: 1. Construct and concurrent validity of the aDIALOG scale are measured using the Mini-MANS LD and the WHOQOL Disabilities module and Clinical Outcome in Routine Evaluation- Learning Disability (CORE-LD), 14 item version (measure of psychological distress) at baseline. 2. Test re-test reliability of the aDIALOG scale is measured by completing the scale at baseline and again 24 hours to 1 week later. WP1b Comparison Testing: 1. Reliability of the aDIALOG scale through measuring the internal consistency and comparing to the original DIALOG scale. 2. Validity of the aDIALOG scale measured using evenness of distribution of scores compared to the original DIALOG scale and confirmatory factor analysis. Previous primary outcomes: WP1a Piloting: 1. Acceptability of / feedback on the intervention is measured using semi-structured interviews / focus groups with at 6 weeks. 2. Intervention implementation processes from the perspective of clinicians and care workers are assessed using the NoMAD questionnaire at 6 weeks. WP1b Psychometric Testing: 1. Construct and concurrent validity of the aDIALOG scale are measured using the Mini-MANS LD and the WHOQOL Disabilities module and Clinical Outcome in Routine Evaluation- Learning Disability (CORE-LD), 14 item version (measure of psychological distress) at baseline. 2. Test re-test reliability of the aDIALOG scale is measured by completing the scale at baseline and again 24 hours to 1 week later. Feasibility studies: 1. Changes in behaviour in service users is measured using the Aberrant Behaviour Checklist (ABC) – Irritability subscale at baseline and 6 months

Secondary

MeasureTime frame
Feasibility studies: 1. Quality of life in service users is measured using the 13- item WHOQOL Disabilities module (WHOQOL-DIS) at baseline and 6 months 2. Community and Leisure participation in service users is measured using the Guernsey Community Participation and Leisure Assessment – Revised (GCPLA-R) at baseline and 6 months 3. Changes in psychological distress in service users is measured using the Learning Disability – Clinical Outcomes in Routine Evaluation, 14 item version (LD-CORE-14) at baseline and 6 months 4. Changes in the presence of psychiatric disorders in service users is measured using the Moss Psychiatric Assessment Schedule - Check (Moss-PAS Check) at baseline and 6 months 5. Changes in behaviour and functioning in service users as a result of the intervention is measured using a modified version of the Clinical Global Impressions Scale – Improvement version (CGI-I) at 6 months 6. Paid and family carer distress in participant carers is measured using the Kessler Psychological Distress Scale - K6 at baseline and 6 months 7. Changes in health-related quality of life in service users is measured using the EuroQol Five Dimensions - Learning Disability modified version of the EQ-5D-3L at baseline and 6 months. A proxy version of the EQ-5D-5L will also be completed by participant carers at baseline and 6 months. 8. Health related quality of life in participant carers is measured using the EQ-5D-5L at baseline and 6 months. 9. Health and social care contacts and medication in service users is measured using a modified version of the Client Services Receipt Inventory (CSRI) at baseline and 6 months. 10. Treatment costs of delivering the intervention are measured using staff time, room bookings and other resource use in participating clinical services and care homes. 11. Intervention implementation processes from the perspective of clinicians and care workers are assessed using the NoMAD questionnaire at 6 months. 12. Recruitment is measured using

Countries

England, United Kingdom

Contacts

Public ContactLaura Miller
l.miller@qmul.ac.uk+44 7352 980401

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: May 1, 2026