Autism Spectrum DisorderCLIECONCT04416360
Autism Spectrum Disorder or Attention Deficit Hyperactivity Disorder in Covid-19 Outbreak
A study testing Interview by psychologists in people with Autism Spectrum Disorder and Attention-deficit Hyperactivity Disorder, run by University Hospital, Toulouse at 5 sites in France.
Trial summary
In response to the coronavirus disease 2019 (covid-19) outbreak, the home confinement of the population ordered by governments in many countries raise questions about its impact on individuals' physical and mental health in the short and longer term. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Autism Spectrum Disorder, Attention-deficit Hyperactivity Disorder
- What is being tested?
- Interview by psychologists
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 5 sitesFrance
- Study dates
- 5 May 2020to 30 Oct 2020
- Phase
- Interventional
- 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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
- Inclusion Criteria: Children / adolescents:
- autism spectrum disorder (ASD) w/wo co-morbidities and/or attention-deficit - hyperactivity disorder (ADHD)
- aged 6 to 17 years (developmental age)
- cared by child psychiatry services involved in the study with continuing care (teleconsultations) during home confinement
- at least one parent consent to participate in the study
- child benefiting from a social security Parents: one or both parents depending on availability and confinement configurations (childcare) Referring caregivers: the referring caregiver will be identified at the time of the child's inclusion in the study
- Exclusion Criteria:
- Parents subject to a judicial safeguard order, guardianship or trusteeship
- Parents or children/adolescents who refuse to participate
- Parents unable to comply with the study requirements because of language or because of lack of access to visio or telephone conference facilities
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Centre Hospitalier de Versailles
Le Chesnay, 78157
Centre Hospitalier Esquirol
Limoges, 87025
Hôpital Robert-Debré (AP-HP)
Paris, 75019
Maison de Solenn (Hôpital Cochin AP-HP)
Paris, 75679
University hospital of Toulouse
Toulouse, Occitanie, 31059
About this study
Official title: Clinical Evolution and Parenting in Children and Adolescents With Autism Spectrum Disorder or Attention Deficit Hyperactivity Disorder Quarantined Because of Covid-19 Outbreak
In response to the coronavirus disease 2019 (covid-19) outbreak, the home confinement of the population ordered by governments in many countries raise questions about its impact on individuals' physical and mental health in the short and longer term. In children, reduced physical activity, changes in lifestyle, disturbances in sleep patterns, lack of in-person contact with peers, poor or inadequate understanding of health risks may be risk factors of anxiety, stress, fatigue, sleep disorders. These problematic effects could be modulated by social factors (housing in urban or rural areas, availability of personal space at home, parenting stress, etc.).
Read the detailed description
Children with Autism Spectrum Disorder (ASD) and/or hyperactive children (ADHD) usually have behavioral and emotional difficulties. The disorders they suffer from, which considerably disturb family life, the therapies they benefit from, which help to organize and structure their daily lives, make them a coherent study group whose observation during home confinement is particularly relevant. Therefore, it is especially interesting to explore the impact of quarantine on the evolution of clinical symptoms and family dynamic.
There is little evidence about the impact of prolonged confinement in these children. The first clinical observations, at the beginning of confinement, reported various situations. Some children showed marked emotional disturbances, whereas others seem to be happy with less social pressure. For ASDs, the ritualization can be a stabilizing factor. For ADHDs, the decrease in school pressure is undoubtedly a positive factor. The availability of parents to create a suitable environment could play a major role. In all cases, changes in care management (teleconsultations for most of them), disruption in routines and lack of points of reference, adjustment in parenting and caring for children for the parents (with difficulties that could increase with prolonged duration of confinement), could have serious long-term effects, but also create opportunities.
So, the present study aim to document the experience of home confinement in children and adolescents with ASD and/or ADHD quarantined because of covid-19 outbreak in various socio-cultural contexts. The experiences reported by the children, their parents and their caregivers will help understand the psychological impact of quarantine.
- Being tested
- Interview by psychologists
- Keywords
- home confinement, Covid-19, qualitative research, Autism Spectrum Disorder, Attention-deficit Hyperactivity Disorder
- Medical subject headings
- Autism Spectrum Disorder, Attention Deficit Disorder with Hyperactivity, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interview by psychologistsOther
Interviews for children / teenagers and parents :
- The questions encourage a narrative
- Repeated interviews: during confinement, at the end of confinement, and 3 months after the end of confinement
- Interviews carried out by videoconference, by trained psychologists not involved in the care process
Interview for referring caregivers: a single interview of approximately 45 minutes, 3 months post-confinement
| Study group | Role | What they receive |
|---|---|---|
| Interview by psychologists | Experimental | Children and adolescent interview Parents interview Referring caregiver interview Receives: Other: Interview by psychologists |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interview of the parents : contextual data
composition, home confinement, change in the environment, personal room at home, screens with internet access, parents' current professional status, teleworking, care, family concerns related to Covid-19, parenting stress, schooling, recurrent complaints.
Measured: Baseline
Interview of the children/adolescents/ parents : Experience of the confinement in general
related to education; related to daily family life; related to leisure, related to care (children/adolescents, parents)
Measured: Baseline
Interview of the children/adolescents/ parents : Experience of the confinement in general
related to education; related to daily family life; related to leisure, related to care (children/adolescents, parents)
Measured: 1 month
Interview of the children/adolescents/ parents : Experience of the confinement in general
related to education; related to daily family life; related to leisure, related to care (children/adolescents, parents)
Measured: 3 months
Interview of the referring caregiver : data relating to disease and management of care
Data relating to disease and management of care. Experience of the referring caregiver.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start5 May 2020
- Primary completion30 Oct 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Malika DELOBEL-AYOUB, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04416360
- Sponsor's protocol ID
- RC31/20/0151
- Acronym
- CLIECO
- Status last verified
- May 2023
- First submitted
- 19 May 2020
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evolution and Parenting in Children and Adolescents With Autism Spectrum Disorder or Attention Deficit Hyperactivity Disorder Quarantined Because of Covid-19 Outbreak
- ClinicalTrials.gov ID
- NCT04416360
- Acronym / sponsor ID
- CLIECO / RC31/20/0151
- Keywords
- home confinement, Covid-19, qualitative research, Autism Spectrum Disorder, Attention-deficit Hyperactivity Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 5 May 2020 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 4 Jun 2020 (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.
In response to the coronavirus disease 2019 (covid-19) outbreak, the home confinement of the population ordered by governments in many countries raise questions about its impact on individuals' physical and mental health in the short and longer term. In children, reduced physical activity, changes in lifestyle, disturbances in sleep patterns, lack of in-person contact with peers, poor or inadequate understanding of health risks may be risk factors of anxiety, stress, fatigue, sleep disorders. These problematic effects could be modulated by social factors (housing in urban or rural areas, availability of personal space at home, parenting stress, etc.).
Detailed description
Children with Autism Spectrum Disorder (ASD) and/or hyperactive children (ADHD) usually have behavioral and emotional difficulties. The disorders they suffer from, which considerably disturb family life, the therapies they benefit from, which help to organize and structure their daily lives, make them a coherent study group whose observation during home confinement is particularly relevant. Therefore, it is especially interesting to explore the impact of quarantine on the evolution of clinical symptoms and family dynamic.
There is little evidence about the impact of prolonged confinement in these children. The first clinical observations, at the beginning of confinement, reported various situations. Some children showed marked emotional disturbances, whereas others seem to be happy with less social pressure. For ASDs, the ritualization can be a stabilizing factor. For ADHDs, the decrease in school pressure is undoubtedly a positive factor. The availability of parents to create a suitable environment could play a major role. In all cases, changes in care management (teleconsultations for most of them), disruption in routines and lack of points of reference, adjustment in parenting and caring for children for the parents (with difficulties that could increase with prolonged duration of confinement), could have serious long-term effects, but also create opportunities.
So, the present study aim to document the experience of home confinement in children and adolescents with ASD and/or ADHD quarantined because of covid-19 outbreak in various socio-cultural contexts. The experiences reported by the children, their parents and their caregivers will help understand the psychological impact of quarantine.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interview by psychologists | Experimental | Other: Interview by psychologistsChildren and adolescent interview Parents interview Referring caregiver interview |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 |
|---|---|---|
| Interview by psychologistsInterviews for children / teenagers and parents : * The questions encourage a narrative * Repeated interviews: during confinement, at the end of confinement, and 3 months after the end of confinement * Interviews carried out by videoconference, by trained psychologists not involved in the care process Interview for referring caregivers: a single interview of approximately 45 minutes, 3 months post-confinement | Other | Interview by psychologists |
Primary outcome
Interview of the parents : contextual data
Time frame: Baseline
composition, home confinement, change in the environment, personal room at home, screens with internet access, parents' current professional status, teleworking, care, family concerns related to Covid-19, parenting stress, schooling, recurrent complaints.
Interview of the children/adolescents/ parents : Experience of the confinement in general
Time frame: Baseline
related to education; related to daily family life; related to leisure, related to care (children/adolescents, parents)
Interview of the children/adolescents/ parents : Experience of the confinement in general
Time frame: 1 month
related to education; related to daily family life; related to leisure, related to care (children/adolescents, parents)
Interview of the children/adolescents/ parents : Experience of the confinement in general
Time frame: 3 months
related to education; related to daily family life; related to leisure, related to care (children/adolescents, parents)
Interview of the referring caregiver : data relating to disease and management of care
Time frame: 3 months
Data relating to disease and management of care. Experience of the referring caregiver.
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 24 May 2023.
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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.
Malika DELOBEL-AYOUB principal investigator
University Hospital, Toulouse
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interview by psychologists in people with Autism Spectrum Disorder and Attention-deficit Hyperactivity Disorder, run by University Hospital, Toulouse at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. 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?
Interview of the parents : contextual data (time frame: Baseline). The study lists 5 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 24 May 2023.