NCT06598358

Brief Summary

Assessment of the usability/ acceptability of the Little Journey app with children aged between 3-12 years old with a diagnosis of autism spectrum disorder (ASD) and experience of attending hospital for a procedure, and their parent (or carer), using a test scenario and semi-structured interview.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
7

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
9 days until next milestone

Study Start

First participant enrolled

September 28, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 14, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

2 months

First QC Date

September 13, 2024

Last Update Submit

September 13, 2024

Conditions

Keywords

Usability study

Outcome Measures

Primary Outcomes (1)

  • Usability/acceptability of the Little Journey application

    Assessment of the usability/acceptability of the Little Journey app by parents/guardians/legal representatives and children aged between 3-12 years old who have a diagnosis of autism spectrum disorder (ASD) and are registered as a patient at BCH, using a test scenario and semi-structured interview.

    1 hour

Study Arms (1)

Children aged 3-12 with ASD diagnosis and their parent/guardian/legal representative

Eligibility Criteria

Age3 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children aged between 3-12 years old who have a diagnosis of autism spectrum disorder (ASD) and are registered as a patient at BCH.

You may qualify if:

  • Child's diagnosis of autism spectrum disorder (ASD)
  • Child aged between 3-12 years old
  • Child is a registered patient at Birmingham Children's Hospital attending hospital as part of their care
  • Child and parent/guardian/legal representative willing and able to participate in study, including child's cognitive ability to use the app
  • Child and parent/guardian/legal representative's ability to understand written English and provide verbal feedback in English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Birmingham Women's and Children's NHS Foundation Trust

Birmingham, B4 6NH, United Kingdom

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2024

First Posted

September 19, 2024

Study Start

September 28, 2024

Primary Completion

November 14, 2024

Study Completion

November 14, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations