Study of Early Communication Home-Learning Offer (ECHO), a targeted communication program for parents/caregivers of children under 2 years old with significant language difficulties and social communication difficulties
| ISRCTN | ISRCTN14728370 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14728370 |
| IRAS number | 331323 |
| Secondary identifying numbers | IRAS 331323 |
- Submission date
- 19/06/2024
- Registration date
- 08/08/2024
- Last edited
- 08/08/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
This study will help us understand how the Early Communication Home-Learning Offer (ECHO) affects children with early signs of social communication difficulties. The ECHO is a parent-child interaction program targeted at children under 2 years old to support early communication development. We would like to understand if this intervention makes a difference to children’s communication skills. We are also interested in how the ECHO changes how parents/caregivers feel about their parenting.
The ECHO was created to give early support for families of children under 2 years old with language difficulties associated with social communication difficulties. Current clinical data indicates that waiting times for speech and language therapy services are longer than the target 18 weeks in many areas of England and that families might benefit from general advice for supporting their child’s communication skills. Currently most community delivered targeted intervention focus on language development while children with social communication difficulties are referred for specialist interventions delivered by speech and language therapists. The ECHO was developed to address this gap and provide a targeted offer that can be delivered by professionals in the community.
Because the ECHO is a new intervention, we need to understand the experiences of the families receiving it. This will provide a better understanding of what families need and how the ECHO can be improved. We will also collect information on how families feel the ECHO is helpful. Our aim is to provide preliminary evidence of the effectiveness and acceptability of this programme, and offer a new intervention, which can support the current population of children and eventually contribute to an evidence based resource for clinicians more widely.
Who can participate?
Families of children under the age of 2 years old who are identified with signs of significant language difficulties and social communication difficulties referred by health visitors and children centres in Manchester Local Authority area.
What does the study involve?
For all children referred to the Early Years Communication and Language Team, we will complete the ECHO intervention. This includes an initial assessment, 5 intervention sessions and a final review.
The 5 intervention sessions will last approximately 45 minutes each and target early communication parent-child interaction strategies.
During the initial assessment visit we will ask parents/caregivers to fill in 2 written questionnaires (TOPSE and CSBS DP), ask questions from another questionnaire (The Pragmatics Profile), and complete 30-45 minutes of assessment (CSBS DP Behaviour Sample, WellComm Language Screen, and Parent-Child Interaction observation) with the parent/caregiver and their child.
The same questionnaires and assessments will be completed at a final review visit 12 weeks following the intervention.
The only difference for families participating in the research study is that we will store data from assessments and questionnaires as well as our clinical observations on a research database.
For more information about the ECHO intervention, please use contact details to request.
What are the possible benefits and risks of participating?
Those taking part will not receive any immediate direct benefit but will contribute to our understanding of how to better support families. Data will help us understand how the ECHO is supporting early communication development and parent/caregiver wellbeing. This will help to shape the care that other families receive. Findings will also be shared with local services who are likely to support participants in the future.
Families may be asked questions that cause mild distress, and these will be asked by professionals trained in support families in difficult conversations. Families will be visited at home and NHS risk management procedures will be followed to minimise any risk or distress caused by home visiting.
Where is the study run from?
This study was developed and managed by the Early Years Communication and Language team within the Manchester University NHS Foundation Trust (UK)
When is the study starting and how long is this expected to run for?
July 2024 to December 2025.
Who is funding this study?
Department for Education and Manchester Local Authority (UK)
Who is the main contact?
Sarah Cameron, sarah.cameron@mft.nhs.uk
Contact information
Public, Scientific, Principal Investigator
1 Stancliffe Road
Manchester
M22 4PJ
United Kingdom
 ORCID ID |
0009-0006-0915-9853 |
|---|---|
| Phone | +44 7976157683 |
| Sarah.Cameron@mft.nhs.uk |
Study information
| Study design | Single-centre single-arm study with mixed methods qualitative study and intervention study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Community, Home |
| Study type | Prevention, Efficacy |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | Early Communication Home-Learning Offer (ECHO): Targeted communication intervention for parents/caregivers of children aged under 24 months identified as having significant language difficulties associated with social communication difficulties: Protocol for a single-centre, single group effectiveness study |
| Study acronym | ECHO Intervention Study |
| Study hypothesis | A targeted intervention (ECHO) on the communication skills of children under 24 months with significant language difficulties and social communication difficulties will produce noticeable improvement in the child's communication skills, on parent-child interactions and parent/caregiver wellbeing. |
| Ethics approval(s) |
Approved 21/05/2024, London - Bromley Research Ethics Committee (2 Redman Place, Stratford, E20 1JQ, United Kingdom; +44 2071048118; bromley.rec@hra.nhs.uk), ref: 24/PR/0471 |
| Condition | Prevention of long-term language difficulties in children with social communication difficulties |
| Intervention | ECHO program includes parent-child interaction strategies delivered to families in 5 face-to-face sessions targeting shared attention, copying, interpreting behaviour as communication, using visuals, and offering opportunities through pausing and choices. The ECHO intervention is delivered by Language Development Workers with a level 3 (or above) qualification in Child Development and supervised by Speech and Language Therapists. The ECHO intervention is delivered by the Early Years Communication and Language Team employed by the Manchester University NHS Foundation Trust within the Manchester Local Authority area. It is delivered in family’s homes and local children’s centres for 5 x 45 minute sessions delivered individually to each family on a weekly basis. Families are followed up 12 weeks after the final session. |
| Intervention type | Behavioural |
| Primary outcome measure | The Communication and Symbolic Behaviour Scales Developmental Profile™ (CSBS DP) (Wetherby, A.; Prizant, B., 2002) clinical assessment at baseline and 12-week follow up |
| Secondary outcome measures | 1. Qualitative interviews completed via Zoom within 12 months of participation in ECHO 2. WellComm Language Screen Early Years Toolkit – paper version (GL Assessments, 2015) measured using clinical observation at baseline and 12-week follow up 3. The Pragmatics Profile of Everyday Communication Skills (Dewart et al., 1995) questionnaire completed by verbal interview at baseline and 12-week follow up 4. The Tool to Measure Parenting Self-Efficacy (TOPSE) (Bloomfield et al., 2010) questionnaire completed by parent/caregiver at baseline and 12-week follow up 5. Clinical outcome measure of parent-child interaction measured using clinical observation at baseline, each intervention session, and 12-week follow up |
| Overall study start date | 01/06/2023 |
| Overall study end date | 31/12/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 11 Months |
| Upper age limit | 24 Months |
| Sex | Both |
| Target number of participants | 40 |
| Participant inclusion criteria | Qualitative Study: 1. Parent/caregiver received at least one ECHO Intervention session within the last 12 months 2. Parent/caregiver residing within the Manchester Local Authority at the time of interview 3. Parent/caregiver having a sufficient level of oral language skills in any language to participate in an in-depth interview as assessed by the researcher’s judgement ECHO Intervention Study: 1. Parent/caregiver and child aged less than 24 months at the start of intervention 2. Parent/caregiver and child who scored Red on the WellComm Language Screen within 3 months of the start of intervention 3. Parent/caregiver and child who scored High Likelihood of autism on Social Attention and Communication Surveillance (SACS-R) tool 4. Residing within the Manchester Local Authority for the duration of intervention |
| Participant exclusion criteria | Qualitative Study: 1. Current significant and ongoing safeguarding concerns. 2. Learning disabilities and/or communication difficulties or disorders that significantly impact parent/caregiver’s capacity to give informed consent and participate in interview even with interpreter support and use of supportive communication strategies. ECHO Intervention Study: 1. Family currently receiving intervention from another Speech and Language Therapy Service. 2. Parent/caregiver already taking part in the study with another child. 3. Child or parent/caregiver has a diagnosis of visual, motor, or hearing impairment. 4. Child has a diagnosis of a developmental disorder other than autism. 5. Current significant and ongoing safeguarding concerns. |
| Recruitment start date | 01/07/2024 |
| Recruitment end date | 31/07/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Manchester
M22 4PJ
United Kingdom
Sponsor information
Hospital/treatment centre
The Nowgen Centre
29 Grafton Street
Manchester
M13 9WU
England
United Kingdom
| Phone | +44 1612764125 |
|---|---|
| research.sponsor@mft.nhs.uk | |
| Website | https://mft.nhs.uk/ |
"ROR" |
https://ror.org/00he80998 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Department for Education, educationgovuk, DfE
- Location
- United Kingdom
No information available
Results and Publications
| Intention to publish date | 01/07/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository |
| Publication and dissemination plan | When the study is completed, results will be analysed and tabulated, and a final study report will be prepared by the Chief Investigator and Principal Investigators. An HRA final study report containing a summary of the results will be completed within 12 months after the study has ended. A more detailed study report will be shared with the Department of Education and the Manchester Local Authority within 2 years of completion of the study. The data will be owned by MFT, and the full study report can be accessed on request to the Early Years Communication and Language Team. Results will also be shared with relevant local services that support families in the target population, in addition to local children’s centres and family hubs where local families in the target population can access them. The results will also be shared with participating families on request via signposting to their local children’s centre. Clinicians will share contact information for the Early Years Communication and Language Team with children centre and family hub staff, so families can get in touch about the results. If families are interested, they can be supported to share their experiences within the local communities. Information from Qualitative Study interviews will be used to understand the patient story and inform how the ECHO Intervention is experienced by families. This information will help inform how the ECHO Intervention may need to be amended to better meet the needs of the target population. Wider dissemination in peer-reviewed journals of general and special interest may also be considered with authorship shared between the Chief Investigator and Principal Investigators. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 1.1 | 16/05/2024 | 24/06/2024 | No | No |
Additional files
Editorial Notes
19/06/2024: Trial's existence confirmed by NHS HRA.
