Behavior, ChildNCT03720028
Angelman & Rett Syndrome: Interaction and Communication
An observational study of Behavior, Child and Parent-Child Relations, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
We aim to describe the communicative and sensory profile of children with Angelman syndrome or Rett syndrome and their use of augmentative and alternative communication. In addition, parents are surveyed regarding parent-child interaction and access to communication support. Read more about this study
- Who is it for?
- Ages 1 year to 14 years
- Conditions the study is for
- Behavior, Child, Parent-Child Relations, Communication
- What is being tested?
- Observation and Parental experiences
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Dec 2018to 1 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 1 year to 14 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with complex communication needs.
Who may be able to join
- Angelman or Rett syndrome
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Parent-child Interaction and Communication in Families Who Have a Child With Rett Syndrome or Angelman Syndrome
We aim to describe the communicative and sensory profile of children with Angelman syndrome or Rett syndrome and their use of augmentative and alternative communication. In addition, parents are surveyed regarding parent-child interaction and access to communication support.
- Conditions
- Behavior, Child, Parent-Child Relations, Communication
- Being tested
- Observation, Parental experiences
- Medical subject headings
- Child Behavior, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationBehavioural
Describe communication and sensory profile using standardized tests and observations.
Parental experiencesBehavioural
Survey parents' experiences with parent-child interaction and augmentative and alternative communication.
| Study group | Role | What they receive |
|---|---|---|
| Child w Angelman/Rett syndrome | Children with Angelman or Rett syndrome, up to 14 years of age Receives: Behavioral: Observation | |
| Parent | Parents of Children with Angelman or Rett syndrome Receives: Behavioral: Parental experiences |
What is being measured
The primary outcome is the main question the study is designed to answer.
Communication profile
Scores on language tests
Measured: 1 day One-time measurement
Parent interaction
Scores on social tests
Measured: 1 day One-time measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start1 Dec 2018
- Primary completion1 Oct 2019
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavior, ChildStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03720028
- Sponsor's protocol ID
- Snummer
- Status last verified
- Oct 2018
- First submitted
- 23 Oct 2018
- Last updated
- 21 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parent-child Interaction and Communication in Families Who Have a Child With Rett Syndrome or Angelman Syndrome
- ClinicalTrials.gov ID
- NCT03720028
- Acronym / sponsor ID
- Snummer
- Conditions
- Behavior, Child, Parent-Child Relations, Communication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- KU Leuven
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 25 Oct 2018 (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.
We aim to describe the communicative and sensory profile of children with Angelman syndrome or Rett syndrome and their use of augmentative and alternative communication. In addition, parents are surveyed regarding parent-child interaction and access to communication support.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Child w Angelman/Rett syndrome | – | Behavioral: ObservationChildren with Angelman or Rett syndrome, up to 14 years of age |
| Parent | – | Behavioral: Parental experiencesParents of Children with Angelman or Rett syndrome |
Who may qualify
- Ages
- 1 year to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with complex communication needs.
Key inclusion criteria (1 listed)
- Angelman or Rett syndrome
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| ObservationDescribe communication and sensory profile using standardized tests and observations. | Behavioural | Child w Angelman/Rett syndrome |
| Parental experiencesSurvey parents' experiences with parent-child interaction and augmentative and alternative communication. | Behavioural | Parent |
Primary outcome
Communication profile
Time frame: 1 day One-time measurement
Scores on language tests
Parent interaction
Time frame: 1 day One-time measurement
Scores on social tests
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2020.
- Individual participant dataSharing planned: No
Related trials for Behavior, Child
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Not yet recruiting
Study of Psychoeducation and Reading for Kids (SPARK)
Reading Difficulties, Behavioral Problems
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Behavior, Child and Parent-Child Relations, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 21 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Communication profile (time frame: 1 day One-time measurement). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Dec 2020.