Autism Spectrum Disorder or Attention Deficit Hyperactivity Disorder in Covid-19 Outbreak

NCT ID: NCT04416360

Last Updated: 2023-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-05
• Study Completion Date: 2020-10-30

Brief 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. 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.

Conditions

Autism Spectrum Disorder; Attention-deficit Hyperactivity Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Interview by psychologists

Children and adolescent interview Parents interview Referring caregiver interview

Group Type: EXPERIMENTAL

Interview by psychologists

Intervention Type: OTHER

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

Interventions

Interview by psychologists

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role: collaborator

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Malika DELOBEL-AYOUB

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

University hospital of Toulouse

Toulouse, Occitanie, France

Centre Hospitalier de Versailles

Le Chesnay, , France

Centre Hospitalier Esquirol

Limoges, , France

Hôpital Robert-Debré (AP-HP)

Paris, , France

Maison de Solenn (Hôpital Cochin AP-HP)

Paris, , France

Countries

France

Other Identifiers

RC31/20/0151

Identifier Type: -

Identifier Source: org_study_id