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

NCT04416360 | Completed

• 1 other identifier: RC31/20/0151
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 5

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.).

Conditions

Autism Spectrum Disorder; Attention-deficit Hyperactivity Disorder

Keywords

home confinement; Covid-19; qualitative research; Autism Spectrum Disorder; Attention-deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (5)

• 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.

  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)

  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)

  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)

  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.

  3 months

Study Arms (1)

Interview by psychologists

EXPERIMENTAL

Children and adolescent interview Parents interview Referring caregiver interview

Other: Interview by psychologists

Interventions

Interview by psychologists 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

Interview by psychologists

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (5)

University hospital of Toulouse

Toulouse, Occitanie, 31059, France

Location

Centre Hospitalier de Versailles

Le Chesnay, 78157, France

Location

Centre Hospitalier Esquirol

Limoges, 87025, France

Location

Hôpital Robert-Debré (AP-HP)

Paris, 75019, France

Location

Maison de Solenn (Hôpital Cochin AP-HP)

Paris, 75679, France

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Attention Deficit Disorder with Hyperactivity; COVID-19

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Malika DELOBEL-AYOUB

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2020
• First Posted: June 4, 2020
• Study Start: May 5, 2020
• Primary Completion: October 30, 2020
• Study Completion: October 30, 2020
• Last Updated: May 24, 2023

Record last verified: 2023-05

Locations

FR (5)