Accessibility and Acceptability of InterventionSoundoriginsNCT07021469
Sound Origins Acceptability Study
A study testing Sound origins in people with Accessibility and Acceptability of Intervention, run by King's College London at 2 sites in United Kingdom.
Trial summary
The goal of this study is to assess the acceptability and accessibility of a co-designed music therapy intervention for parents with infants with uncertain futures and nursing staff on the neonatal unit. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Accessibility and Acceptability of Intervention
- What is being tested?
- Sound origins
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 1 Sep 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parent inclusion criteria:
- 18+ years
- Has an infant diagnosed with a condition meeting the infant inclusion criteria on admission to the unit (see below)
- Can give informed consent
- Healthcare professional inclusion criteria:
- Nursing professional working with or providing support to parents with infants diagnosed with a life limiting condition involved in the study
Show all 14Show fewer
- Part time, full time on UCLH neonatal unit
- Any grade
- Infant inclusion
- In accordance with Together for short lives neonatal palliative care guidelines any parent who has an infant meeting the following criteria whilst on the neonatal unit will be eligible for the intervention:
- Category 1: Life-threatening conditions for which curative treatment may be feasible but can fail Provision of palliative care services may be necessary when treatment fails or during an acute crisis, irrespective of the duration of threat to life. On reaching long-term remission or following successful curative treatment there is no longer a need for palliative care services. Examples: extreme prematurity, severe necrotising enterocolitis, congenital heart disease.
- Category 2 Conditions where premature death is inevitable. There may be long periods of intensive treatment aimed at prolonging life and allowing participation in normal activities. Example: chromosomal abnormality, severe spina bifida, bilateral multi-cystic dysplastic kidneys, bilateral renal agenesis.
- Category 3 Progressive conditions without curative treatment options Treatment is exclusively palliative and may commonly extend over many years. Example: skeletal dysplasia, severe neuromuscular disorders.
- Category 4 Irreversible but non-progressive conditions causing severe disability, leading to susceptibility to health complications and likelihood of premature death. Example: severe hypoxic ischaemic encephalopathy.
Who cannot join
- Parent exclusion criteria
- <18+ years
- Acute mental health diagnosis e.g schizophrenia, psychosis
- Substance abuse
- Does not have an infant meeting inclusion criteria
- Unable to provide consent
Show all 9Show fewer
- Healthcare professional exclusion criteria
- not working with or providing support to parents with infants diagnosed with a life limiting condition
- agency staff
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Glenn Robert contact
United Kingdom2 sites
Kings College London
London, Professor
Glenn Robert, glenn.robert@kcl.ac.uk
Glenn Robert
University College London Hospital Neonatal Unit
London, SG12 7DH
Kirsty Jane, +447825286275, kirsty.jane@kcl.ac.uk
Kirsty Jane
About this study
Official title: Sound Origins: Assessment of the Acceptability and Accessibility of a Co-designed Music Therapy Intervention
The goal of this study is to assess the acceptability and accessibility of a co-designed music therapy intervention for parents with infants with uncertain futures and nursing staff on the neonatal unit. The main questions it aims to answer are:
- To assess the acceptability and accessibility of the co-designed music therapy intervention
- To assess the frequency of recruitment and retention of the participants
- To assess the feasibility of the creation and sharing of a musical gift within 1 week
- To assess the appropriateness of the timeframe for interview of parents who experience neonatal death during the study timeframe.
Read more
Participants will test an intervention comprising of:
- Playlists created by parents with lived experience for parents to use as ideas for music they could use for themselves or with baby on the unit. This is shared via QR code in a journal and on the study website which will be provided at the time of the consent.
- Parent Journal: This journal provides a guide for using music and self-reflection. It also has the link for the playlists.
- 'Musical gifts' created with the support of a music therapist from external family/ friends to the baby on the unit. Contact will be on MsTeams with individual age 18 or over or supported by an adult. Music will be created by contact to send direct to family on the neonatal unit as a voice note. If requested the family may send a voice note to the music therapist to then add to to make more complex music using 'Audacity' software to then be returned to the contact via 'we transfer' for approval before sharing with the family on the unit.
- Nurses shared playlist: This is a playlist for nursing staff to create their own shared playlist using their music.
- 'Ask me' badges. These badges are optional for nurses to wear during their shifts but will act as a symbol to parents that their nurse is available to speak to about music
Read the detailed description
Testing a co-designed music therapy intervention:
This study will aim to test a co-designed music therapy interventions with 12 parents of 12 infants with uncertain futures at University College London hospital and the nurses that care for them during this period.
Parents will be approached by the lead researcher, research nurse or lead consultant about participating in the study. They will be given information sheets outlining what will be expected and the potential burdens and benefits of taking part. They will be given 24hrs to consider the study before providing consent. The lead researcher will then approach to gain consent and answer any questions on the study. If consent is given, the cot side nurse will provide the family with the journal and make a referral to music therapy. A meeting with the unit music therapist will then be made and the following discussed:
- contact with a nominated person off the unit to create a musical gift for the baby (external contact will need to be age 18 or over, siblings/ children can be included if supported by an adult). Meeting held via MSTeams.
- explanation of a website and parent playlists
- a journal
After the music therapist has worked with the external contact and a musical gift created (likely to be a lullaby) it will be sent to the family either by the family contact or the music therapists as preferred by the parent. On day 7 of the study the music therapist will check in with the parent on the unit to review the materials and offer further support. Journal entries will not be shared with any member of staff or the researcher unless parents wish to. Parents can then chose to continue support or use the resources independently.
During the study period parents will be asked to complete questionnaires assessing psychological safety (Neuroception of psychological safety scale NPSS-G). These will be completed on the unit on day 1 and 16 of the study via hardcopy. Once completed, parents can leave with the reception in a sealed envelope (provided). This will then be stored in a locked research cabinet until the lead research is able to collect. Separately, nursing staff involved in the care of these babies will be encouraged to build a shared playlist to support staff relationships and regulation through music. They will be sent a digital link to the website which gives instruction and guide to engagement with families through music as well as advise on building a staff playlist. They will also be provided with 'ask me' badges to wear to signal their availability to parents that they are happy to engage in conversation about the parents use of music and the value of certain music to their family.
Evaluation of acceptability:
At the end of the study period (3 weeks) parents will be asked to complete an acceptability survey and attend a short interview. Where a baby has died parents will be contacted 6 weeks after the death to consent their continued participation in the study and completion of the survey and interview. The lead researcher will contact parents to arrange a time for a short interview either at the parents home or at a University College London Hospital research room to discuss the acceptability of the intervention further. Similarly health care professionals will also be ask to complete an acceptability survey at the end of the intervention being testing on the unit (4 months) and encouraged to give feedback on their use of the playlist and the 'ask me' badges. Prior to completing the questionnaire they will be required to complete a consent form where they can tick if they would like to be contacted to participate in an online focus group to discuss their experiences further. Those who chose to do this will be provided with an overview of the topics for discussion prior to the group.
Celebration event:
A celebration event will be held at King's Place, London to celebrate the development of the intervention and the value of the engagement from everyone who has been involved at all stages. Everyone involved at any stage of the research will be invited to this event. It will also be extended to healthcare professionals and family support charities.
- Being tested
- Sound origins
- Keywords
- music therapy, acceptablity, neonatal, NICU, palliative care, experienced based co-design
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sound originsOther
Also called Sound origins music therapy approach, Neonatal music therapy intervention
Parents:
- Playlists created by parents with lived experience for parents to use as ideas for music they could use for themselves or with baby on the unit.
- Parent Journal: This journal provides a guide for using music and self-reflection. It also has the link for the playlists.
- 'Musical gifts' created with the support of a music therapist from external family/ friends to the baby on the unit.
Nursing staff caring for families participating in the study:
- Nurses shared playlist. Suggested creation of 3 playlists for nursing staff to create their own shared playlist using their music.
- 'Ask me' badges. These badges are optional for nurses to wear during their shifts but will act as a symbol to parents that their nurse is available to speak to about music.
| Study group | Role | What they receive |
|---|---|---|
| Parent and staff participants | Experimental | Parents with infants with uncertain futures on admission to the neonatal unit and the nurses caring for them. Receives: Other: Sound origins |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability Questionnaire
A non-validated questionnaire developed by the researchers will assess the acceptability of the intervention based on domains from Sekon's Theoretical Framework of Acceptability. The framework includes the following domains: Affective attitude, burden, ethicality, perceived effectiveness, opportunity cost, intervention coherence, self-efficacy. These will be assessed through one questionnaire.
Measured: Parents will be assessed after completing the intervention for 3 weeks. Staff will complete the questionnaire at the end of the full study duration. This will be either after 4 months or when 12 parents have participated whichever is first.
Secondary outcomes (1)
Neuroception of psychological safety scale- NPSS
Assessment of parent perceived psychological safety: Participants rate how well statements describe their feelings on a likert scale (strongly disagree =1 up to Strongly Agree=5). Higher scores relate to higher levels of perceived psychological safety.
Measured: Days 1 and 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start1 Sep 2025 (estimated)
- Primary completion30 Mar 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Accessibility and Acceptability of InterventionStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Glenn Robert, PhD, Study chair, King's College LondonKirsty Jane, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07021469
- Sponsor's protocol ID
- 355379
- Acronym
- Soundorigins
- Status last verified
- May 2025
- First submitted
- 28 May 2025
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a small scale acceptability testing study as part of the lead researchers PhD.
Publications
Jane K, Wood D, Gallagher K, Livermore P, Shoemark H, Robert G. Parents' experiences of psychotherapeutic support on the neonatal unit: A mixed methods systematic review to inform intervention development for a multicultural population. Nurs Crit Care. 2025 May;30(3):e13194. doi: 10.1111/nicc.13194. Epub 2024 Oct 28.
PubMed 39467007Standley J. Music therapy with premature infant: Research and developmental interventions. Music Therapy Perspectives. 2003;23(1):76-8.
Loewy J, Stewart K, Dassler AM, Telsey A, Homel P. The effects of music therapy on vital signs, feeding, and sleep in premature infants. Pediatrics. 2013 May;131(5):902-18. doi: 10.1542/peds.2012-1367. Epub 2013 Apr 15.
PubMed 23589814Flaks MK, Malta SM, Almeida PP, Bueno OF, Pupo MC, Andreoli SB, Mello MF, Lacerda AL, Mari JJ, Bressan RA. Attentional and executive functions are differentially affected by post-traumatic stress disorder and trauma. J Psychiatr Res. 2014 Jan;48(1):32-9. doi: 10.1016/j.jpsychires.2013.10.009. Epub 2013 Oct 22.
PubMed 24199652Al Maghaireh DF, Abdullah KL, Chan CM, Piaw CY, Al Kawafha MM. Systematic review of qualitative studies exploring parental experiences in the Neonatal Intensive Care Unit. J Clin Nurs. 2016 Oct;25(19-20):2745-56. doi: 10.1111/jocn.13259. Epub 2016 Jun 3.
PubMed 27256250Fraser. L. G-SD, Jarvis. D., Norman. P., Parslow. R., . 'Make Every Child Count' Estimating current and future prevalence of children and young people with life-limiting conditions in the United Kingdom. Together for Short Lives. 2020.
NCMD. NCMD Second Annual Report. Child Death Review Data. 2021.
Dickson G. A Perinatal Pathway for Babies with Palliative Care Needs, 2nd Edition. Together for Short Lives. 2019.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sound Origins: Assessment of the Acceptability and Accessibility of a Co-designed Music Therapy Intervention
- ClinicalTrials.gov ID
- NCT07021469
- Acronym / sponsor ID
- Soundorigins / 355379
- Keywords
- music therapy, acceptablity, neonatal, NICU, palliative care, experienced based co-design
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 30 Mar 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 15 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to assess the acceptability and accessibility of a co-designed music therapy intervention for parents with infants with uncertain futures and nursing staff on the neonatal unit. The main questions it aims to answer are:
- To assess the acceptability and accessibility of the co-designed music therapy intervention
- To assess the frequency of recruitment and retention of the participants
- To assess the feasibility of the creation and sharing of a musical gift within 1 week
- To assess the appropriateness of the timeframe for interview of parents who experience neonatal death during the study timeframe.
Participants will test an intervention comprising of:
- Playlists created by parents with lived experience for parents to use as ideas for music they could use for themselves or with baby on the unit. This is shared via QR code in a journal and on the study website which will be provided at the time of the consent.
- Parent Journal: This journal provides a guide for using music and self-reflection. It also has the link for the playlists.
- 'Musical gifts' created with the support of a music therapist from external family/ friends to the baby on the unit. Contact will be on MsTeams with individual age 18 or over or supported by an adult. Music will be created by contact to send direct to family on the neonatal unit as a voice note. If requested the family may send a voice note to the music therapist to then add to to make more complex music using 'Audacity' software to then be returned to the contact via 'we transfer' for approval before sharing with the family on the unit.
- Nurses shared playlist: This is a playlist for nursing staff to create their own shared playlist using their music.
- 'Ask me' badges. These badges are optional for nurses to wear during their shifts but will act as a symbol to parents that their nurse is available to speak to about music
Detailed description
Testing a co-designed music therapy intervention:
This study will aim to test a co-designed music therapy interventions with 12 parents of 12 infants with uncertain futures at University College London hospital and the nurses that care for them during this period.
Parents will be approached by the lead researcher, research nurse or lead consultant about participating in the study. They will be given information sheets outlining what will be expected and the potential burdens and benefits of taking part. They will be given 24hrs to consider the study before providing consent. The lead researcher will then approach to gain consent and answer any questions on the study. If consent is given, the cot side nurse will provide the family with the journal and make a referral to music therapy. A meeting with the unit music therapist will then be made and the following discussed:
- contact with a nominated person off the unit to create a musical gift for the baby (external contact will need to be age 18 or over, siblings/ children can be included if supported by an adult). Meeting held via MSTeams.
- explanation of a website and parent playlists
- a journal
After the music therapist has worked with the external contact and a musical gift created (likely to be a lullaby) it will be sent to the family either by the family contact or the music therapists as preferred by the parent. On day 7 of the study the music therapist will check in with the parent on the unit to review the materials and offer further support. Journal entries will not be shared with any member of staff or the researcher unless parents wish to. Parents can then chose to continue support or use the resources independently.
During the study period parents will be asked to complete questionnaires assessing psychological safety (Neuroception of psychological safety scale NPSS-G). These will be completed on the unit on day 1 and 16 of the study via hardcopy. Once completed, parents can leave with the reception in a sealed envelope (provided). This will then be stored in a locked research cabinet until the lead research is able to collect. Separately, nursing staff involved in the care of these babies will be encouraged to build a shared playlist to support staff relationships and regulation through music. They will be sent a digital link to the website which gives instruction and guide to engagement with families through music as well as advise on building a staff playlist. They will also be provided with 'ask me' badges to wear to signal their availability to parents that they are happy to engage in conversation about the parents use of music and the value of certain music to their family.
Evaluation of acceptability:
At the end of the study period (3 weeks) parents will be asked to complete an acceptability survey and attend a short interview. Where a baby has died parents will be contacted 6 weeks after the death to consent their continued participation in the study and completion of the survey and interview. The lead researcher will contact parents to arrange a time for a short interview either at the parents home or at a University College London Hospital research room to discuss the acceptability of the intervention further. Similarly health care professionals will also be ask to complete an acceptability survey at the end of the intervention being testing on the unit (4 months) and encouraged to give feedback on their use of the playlist and the 'ask me' badges. Prior to completing the questionnaire they will be required to complete a consent form where they can tick if they would like to be contacted to participate in an online focus group to discuss their experiences further. Those who chose to do this will be provided with an overview of the topics for discussion prior to the group.
Celebration event:
A celebration event will be held at King's Place, London to celebrate the development of the intervention and the value of the engagement from everyone who has been involved at all stages. Everyone involved at any stage of the research will be invited to this event. It will also be extended to healthcare professionals and family support charities.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parent and staff participants | Experimental | Other: Sound originsParents with infants with uncertain futures on admission to the neonatal unit and the nurses caring for them. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 18+ years
- Has an infant diagnosed with a condition meeting the infant inclusion criteria on admission to the unit (see below)
- Can give informed consent
- Nursing professional working with or providing support to parents with infants diagnosed with a life limiting condition involved in the study
- Part time, full time on UCLH neonatal unit
Key exclusion criteria (9 listed)
- Parent exclusion criteria
- <18+ years
- Acute mental health diagnosis e.g schizophrenia, psychosis
- Substance abuse
- Does not have an infant meeting inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sound originsAlso: Sound origins music therapy approach, Neonatal music therapy interventionParents: 1. Playlists created by parents with lived experience for parents to use as ideas for music they could use for themselves or with baby on the unit. 2. Parent Journal: This journal provides a guide for using music and self-reflection. It also has the link for the playlists. 3. 'Musical gifts' created with the support of a music therapist from external family/ friends to the baby on the unit. Nursing staff caring for families participating in the study: 1. Nurses shared playlist. Suggested creation of 3 playlists for nursing staff to create their own shared playlist using their music. 2. 'Ask me' badges. These badges are optional for nurses to wear during their shifts but will act as a symbol to parents that their nurse is available to speak to about music. | Other | Parent and staff participants |
Primary outcome
Acceptability Questionnaire
Time frame: Parents will be assessed after completing the intervention for 3 weeks. Staff will complete the questionnaire at the end of the full study duration. This will be either after 4 months or when 12 parents have participated whichever is first.
A non-validated questionnaire developed by the researchers will assess the acceptability of the intervention based on domains from Sekon's Theoretical Framework of Acceptability. The framework includes the following domains: Affective attitude, burden, ethicality, perceived effectiveness, opportunity cost, intervention coherence, self-efficacy. These will be assessed through one questionnaire.
1 secondary outcome
Neuroception of psychological safety scale- NPSS
Time frame: Days 1 and 16
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- Background: PubMed 39467007Jane K, Wood D, Gallagher K, Livermore P, Shoemark H, Robert G. Parents' experiences of psychotherapeutic support on the neonatal unit: A mixed methods systematic review to inform intervention development for a multicultural population. Nurs Crit Care. 2025 May;30(3):e13194. doi: 10.1111/nicc.13194. Epub 2024 Oct 28.
- BackgroundStandley J. Music therapy with premature infant: Research and developmental interventions. Music Therapy Perspectives. 2003;23(1):76-8.
- Background: PubMed 23589814Loewy J, Stewart K, Dassler AM, Telsey A, Homel P. The effects of music therapy on vital signs, feeding, and sleep in premature infants. Pediatrics. 2013 May;131(5):902-18. doi: 10.1542/peds.2012-1367. Epub 2013 Apr 15.
- Background: PubMed 24199652Flaks MK, Malta SM, Almeida PP, Bueno OF, Pupo MC, Andreoli SB, Mello MF, Lacerda AL, Mari JJ, Bressan RA. Attentional and executive functions are differentially affected by post-traumatic stress disorder and trauma. J Psychiatr Res. 2014 Jan;48(1):32-9. doi: 10.1016/j.jpsychires.2013.10.009. Epub 2013 Oct 22.
- Background: PubMed 27256250Al Maghaireh DF, Abdullah KL, Chan CM, Piaw CY, Al Kawafha MM. Systematic review of qualitative studies exploring parental experiences in the Neonatal Intensive Care Unit. J Clin Nurs. 2016 Oct;25(19-20):2745-56. doi: 10.1111/jocn.13259. Epub 2016 Jun 3.
- BackgroundFraser. L. G-SD, Jarvis. D., Norman. P., Parslow. R., . 'Make Every Child Count' Estimating current and future prevalence of children and young people with life-limiting conditions in the United Kingdom. Together for Short Lives. 2020.
- BackgroundNCMD. NCMD Second Annual Report. Child Death Review Data. 2021.
- BackgroundDickson G. A Perinatal Pathway for Babies with Palliative Care Needs, 2nd Edition. Together for Short Lives. 2019.
- Sound Origins Study, King's College LondonLink provided by the sponsor.
- Individual participant dataSharing planned: No. This is a small scale acceptability testing study as part of the lead researchers PhD.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Glenn Robert contact
Glenn Robert, PhD study chair
King's College London
Kirsty Jane principal investigator
King's College London
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sound origins in people with Accessibility and Acceptability of Intervention, run by King's College London at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bashir Al Hashimi (+447540670429, vpri@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability Questionnaire (time frame: Parents will be assessed after completing the intervention for 3 weeks. Staff will complete the questionnaire at the end of the full study duration. This will be either after 4 months or when 12 parents have participated whichever is first.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07021469, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2025.