ISRCTN ISRCTN57161991
DOI https://doi.org/10.1186/ISRCTN57161991
Integrated Research Application System (IRAS) 350650
Central Portfolio Management System (CPMS) 65260
National Institute for Health and Care Research (NIHR) 168754
Sponsor University of Birmingham
Funder National Institute for Health and Care Research
Submission date
19/05/2026
Registration date
02/06/2026
Last edited
16/07/2026
Recruitment status
Recruiting
Overall study status
Ongoing
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Many children with learning disabilities experience significant behaviour and emotional difficulties. Support programmes can assist families with these challenges, but accessing such supports can be difficult for parents. Digital technology, such as online programmes, is one way to provide support for parents caring for a child with learning disabilities. Accessing programmes online can sometimes be easier for families than attending sessions in person. We have planned a study to test the potential benefits of Stepping Stones Online.

Who can participate?
Families will be able to take part in the research if they have a child with learning disabilities aged 2-11 years and they are worried about their child’s behaviour.

What does the study involve?
Whether families will receive Stepping Stones Online straightaway or later will be decided by chance (this is called randomisation). We will collect information from parent carers before families are randomised and around 6 and 12 months later. To find out more about what families think about Stepping Stones Online, we will interview some parent carers. We will also interview the family carers who offer the additional support alongside Stepping Stones Online

What are the possible benefits and risks of participating?
By taking part in this study, you will be helping to answer whether Stepping Stones Online is beneficial to parent carers and children with a learning disability. The results of this study may benefit parent carers and children with a learning disability in the future. You will be asked to fill out questionnaires before the study begins and then 6 months and 12 months later. These questionnaires may take time to complete, and we ask that you do complete them. The questionnaires include positive things but will also ask you to reflect on challenges you may face with your child.

Where is the study run from?
The study is being led/sponsored by University of Birmingham and is being carried out with the Centre for Trials Research at Cardiff University (UK)

When is the study starting and how long is it expected to run for?
June 2026 to February 2029

Who is funding the study?
National Institute for Health and Care Research (NIHR) Health Technology Assessment Programme (UK)

Who is the main contact?
Daisy-online@contacts.bham.ac.uk

Contact information

Dr Emma Scripps
Public

University of Birmingham
Birmingham
B15 2TT
United Kingdom

Phone +44 (0)7483123993
Email Daisy-online@contacts.bham.ac.uk
Prof Kylie Grey
Scientific, Principal investigator

University of Birmingham
Birmingham
B15 2TT
United Kingdom

Phone +44 (0)2476523638
Email k.m.gray@bham.ac.uk

Study information

Primary study designInterventional
AllocationRandomized controlled trial
MaskingBlinded (masking used)
ControlActive
AssignmentParallel
PurposeSupportive care, Treatment
Participant information sheet 49563_PIS__V2.0_28Apr2026.pdf
Scientific titleA randomised controlled trial of a digital parent support programme for parents of children with intellectual disabilities: the Digital Family Support study
Study acronymDAISY
Study objectives Does Stepping Stones Online and access to usual supports (US) lead to improvements in the behavioural and emotional problems of children with intellectual disabilities compared to US alone at 12 months post randomisation?
Ethics approval(s)

Approved 29/04/2026, Wales REC 7 (Floor 4, Crown Building, Cardiff, CF10 3NQ, United Kingdom; N/A; Wales.REC7@wales.nhs.uk), ref: 26/WA/0117

Health condition(s) or problem(s) studiedParenting practices and parental well-being
InterventionParticipants will be randomised online using minimisation.

Stepping Stones Online is designed to support and empower parent carers of a child with intellectual disability aged 2-11 years by increasing their confidence and skills in managing behavioural and emotional problems and promoting positive child behaviour. Improvement in child behavioural and emotional problems leads to improvement in parental wellbeing and reduction in parental stress, and in turn improvements in family relationships.

The control group will access support as usual during the trial but they will be given access to the Stepping Stones Online Intervention for 1 year at the end of their participation in the trial.
Intervention typeBehavioural
Primary outcome measure(s)
  1. Child behaviour and emotional problems measured using the Developmental Behavior Checklist at baseline, 6 months, and 12 months
Key secondary outcome measure(s)
  1. Parent wellbeing measured using the Warwick-Edinburgh Mental Wellbeing Scale at baseline, 6 months, 12 months
  2. Parenting practices measured using the Parenting Scale Short Form at baseline, 6 months, 12 months
  3. Parent psychological distress measured using Kessler 6 at baseline, 12 months
  4. Parent social isolation measured using the UCLA Three-Item Loneliness Scale at Baseline, 12 months
  5. Parenting emotion regulation measured using the Bangor Mindful Parenting Scale at baseline, 12 months
  6. Parent-child relationship quality measured using the Child Parent Relationship Scale at baseline, 12 months
  7. Parental empowerment measured using the Parenting Sense of Competence Scale Revised at baseline, 12 months
  8. Children’s adaptative functioning and communication measured using the GO4KIDDS brief adaptive scale at baseline, 12 months
  9. Parent quality of life measured using EQ-5D-5L at baseline, 12 months
  10. Child quality of life measured using EQ-5D-Y-3L at baseline, 12 months
  11. Child quality of life measured using the Paediatric Quality of Life Inventory at baseline, 12 months
  12. Health and social care service use and cost effectiveness of the intervention measured using EQ-5D-5L, EQ-5D-Y-3L, Paediatric Quality of Life Inventory, and Client Service Receipt Inventory at baseline, 12 months
  13. Process evaluation measured using adherence and fidelity at 12 months
Completion date28/02/2029

Eligibility

Participant type(s)
Age groupMixed
Lower age limit18 Years
Upper age limit100 Years
SexAll
Target sample size at registration432
Key inclusion criteriaCurrent key inclusion criteria as of 16/07/2026:
1. Family has child aged 2-11 years with an intellectual disability (ID)
2. The identified child with intellectual disability meets the following:
2.1. Has a diagnosis or is in the process of exploring a diagnosis or the child’s presentation is related to intellectual and/or severe developmental disabilities – including but not restricted to ‘Learning Disability’, Global Developmental Delay, Pervasive Developmental Delay or Special Educational Needs
AND
2.2. Has an Adaptive Behavior Composite score on the Vineland Adaptive Behaviour Scales (VABS-3, Comprehensive Interview Form) of <80
3. A biological, step, adoptive, foster parent carer available to complete the intervention and study measures
4. Parent carer English language ability sufficient to engage with the Stepping Stones Online programme (with or without support)
5. Parent carer aged ≥18 years
6. Parent carer(s) concerned about the child with ID’s behavioural and/or emotional problems
7. Parent carer lives in England
8. Parent carer able to provide informed consent


Previous key inclusion criteria:
1. Family has child aged 2-11 years with an intellectual disability (ID)
2. The identified child with intellectual disability meets the following:
2.1. Has a diagnosis or is in the process of exploring a diagnosis or the child’s presentation is related to intellectual and/or severe developmental disabilities – including but not restricted to ‘Learning Disability’, Global Developmental Delay, Pervasive Developmental Delay or Special Educational Needs
AND
2.2. Has an Adaptive Behavior Composite score on the Vineland Adaptive Behaviour Scales (VABS-3, Comprehensive Interview Form) of <80
3. A biological, step, adoptive, foster parent carer available to complete the intervention and study measures
4. Parent carer English language ability sufficient to engage with the Stepping Stones Online programme
5. Parent carer aged ≥18 years
6. Parent carer(s) concerned about the child with ID’s behavioural and/or emotional problems
7. Parent carer lives in England
8. Parent carer able to provide informed consent
Key exclusion criteria1. Child with intellectual disability is in 24-hour residential placement
2. Child with intellectual disability is in a foster placement due to end before the 12-month post-randomisation follow-up data collection point
3. There are current child protection concerns relating to the child with ID that have been indicated to the research team at the point of recruitment
4. The family is not in a position to engage with the intervention (for example, the family is in crisis)
5. Another parent carer in the family has already been recruited into the trial
6. Parent carer is unable to access the internet, despite support provided
7. Families where one or more parents have received a multi-session parenting programme covering similar content to Stepping Stones Online over the previous 12 months
8. Families where one or more parents are currently receiving a multi-session parenting programme covering similar content to Stepping Stones Online or any multi-component manualised family intervention, such as, for example, Multi-Systemic Therapy, Stepping Stones Triple P
9. Primary residence outside of England
Date of first enrolment05/06/2026
Date of final enrolment31/08/2027

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Birmingham University
Edgbaston
Birmingham
B15 2TT
England

Results and Publications

Individual participant data (IPD) Intention to shareNo

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet version 2.0 28/04/2026 19/05/2026 No Yes
Protocol file version 1 01/04/2026 19/05/2026 No No

Additional files

49563_PIS__V2.0_28Apr2026.pdf
Participant information sheet
49563 _PROTOCOL_V1_01Apr2026.pdf
Protocol file

Editorial Notes

16/07/2026: The key inclusion criteria were updated.
19/05/2026: Study's existence confirmed by the NIHR.