Autism Spectrum DisordercoquilleNCT06867783
EVALUATION FOR YOUNG CHILDREN WITH AUTISM SPECTRUM DISORDERS
A study testing coquille in people with Autism Spectrum Disorder, run by Centre hospitalier de Ville-Evrard, France at 1 site in France.
Trial summary
Collaborative early management of children under 30 months with autism spectrum disorder and their families in an ambulatory child psychiatry unit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- coquille
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteFrance
- Study dates
- 29 Nov 2024to 1 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years and over
- French language spoken and written by the parent
- Free and informed consent form , initialled and signed by the parent
- Child under 30 months of age at time of inclusion, diagnosed with autism spectrum disorder
- Total CARS score greater than or equal to 30
- Free and informed consent form, initialled and signed by legal representatives
Who cannot join
- Any acute, somatic or psychiatric clinical condition of the mother not compatible with therapeutic intervention.
- Current engagement in an interventional research protocol
- Mother under protection of justice, guardianship or enhanced curatorship
- Mother no longer having parental authority
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EVALUATION OF EARLY FAMILY AND MULTIFAMILY INTERVENTION FOR YOUNG CHILDREN WITH AUTISM SPECTRUM DISORDERS
Collaborative early management of children under 30 months with autism spectrum disorder and their families in an ambulatory child psychiatry unit.
Read the detailed description
Early intervention in Autism Spectrum Disorder (ASD) is now considered a priority. An approach that targets both child disorders and parental distress, and supports the skills of parents, is desirable. Yet there is no early intervention by the ASD involving parents and targeting both child functioning and parenting skills specifically.
Our objective is to evaluate quantitatively and qualitatively the collaborative family support system for ASD "Coquille". This scheme combines the development of a personalized care project based on parents' priorities, an intensive single-family parent-child follow-up and a group of multi-family therapy , over a total period of 6 months. Our main hypothesis is the significant decrease in behavioral disorders of children, evaluated by CARS, following the Coquille device. Our secondary hypotheses concern the evolution of parental dimensions following the device (sense of coherence, parental skills, parental stress, coping strategies and social support). We assume that these dimensions will change as a result of the scheme, and that they will be maintained in the medium term, six months after Coquille. A semi-structured interview will qualitatively explore the dimensions related to family resources, before and after the follow-up and in the medium term. This will also allow the mother to collect experience of the device.
- Conditions
- Autism Spectrum Disorder
- Being tested
- coquille
- Keywords
- Autism Spectrum Disorder - coquille device
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coquilleDevice
Modalities: Elaboration of the personalized care project, follow-up parents-child single family, multi-family therapy (MFT).
Frequency: MFT weekly, bi-familial observation weekly for one month, single-parent child-parent monitoring weekly for five months, MFT father-child bimonthly for six months, three co-parents, three child psychiatric consultations to develop the personalized collaborative care project
| Study group | Role | What they receive |
|---|---|---|
| coquille device | Other | collaborative family support scheme aimed at improving family functioning and child behaviour Receives: Device: coquille |
What is being measured
The primary outcome is the main question the study is designed to answer.
Childhood Autism Rating, Scale, CARS
CARS works by rating your child's behavior, characteristics, and abilities against the expected developmental growth of a typical child.It is done by your primary healthcare provider, a teacher, or a parent by rating the child's behaviors from 1 to 4. 1 being normal for your child's age, 2 for mildly abnormal, 3 for moderately abnormal, and 4 as severely abnormal. Scores range from 15 to 60 with 30 being the cutoff rate for a diagnosis of mild autism. Scores 30-37 indicate mild to moderate autism, while scores between 38 and 60 are characterized as severe autism.
Measured: It is done before the sign of the consent (T-1),
Childhood Autism Rating, Scale, CARS
CARS works by rating your child's behavior, characteristics, and abilities against the expected developmental growth of a typical child.It is done by your primary healthcare provider, a teacher, or a parent by rating the child's behaviors from 1 to 4. 1 being normal for your child's age, 2 for mildly abnormal, 3 for moderately abnormal, and 4 as severely abnormal. Scores range from 15 to 60 with 30 being the cutoff rate for a diagnosis of mild autism. Scores 30-37 indicate mild to moderate autism, while scores between 38 and 60 are characterized as severe autism.
Measured: Six month after the use of coquille device (T1)
Childhood Autism Rating, Scale, CARS
CARS works by rating your child's behavior, characteristics, and abilities against the expected developmental growth of a typical child.It is done by your primary healthcare provider, a teacher, or a parent by rating the child's behaviors from 1 to 4. 1 being normal for your child's age, 2 for mildly abnormal, 3 for moderately abnormal, and 4 as severely abnormal. Scores range from 15 to 60 with 30 being the cutoff rate for a diagnosis of mild autism. Scores 30-37 indicate mild to moderate autism, while scores between 38 and 60 are characterized as severe autism.
Measured: Six month after the follow up (T2)
Sociodemographic and lifestyle
The socio-demographic questionnaire contains 4 items:
Socio-demographic criteria (gender, date of birth, level of education, marital status and number of children), diet, screen, and sleep.
Measured: Immediately after the sign of the consent (T0)
Sociodemographic and lifestyle
The socio-demographic questionnaire contains 4 items:
Socio-demographic criteria (gender, date of birth, level of education, marital status and number of children), diet, screen, and sleep.
Measured: Six month after the use of coquille device (T1)
Sociodemographic and lifestyle
The socio-demographic questionnaire contains 4 items:
Socio-demographic criteria (gender, date of birth, level of education, marital status and number of children), diet, screen, and sleep.
Measured: Six month after the follow up (T2)
Parental Stress Scale
The Parental Stress Scale (PSS) was created in 1995 to measure stress unique to parenting and captures both the joys and demands of parenting. Each following sentences describe feelings and perceptions that relate to the experience of being a parent. The PSS is brief and can be completed in less than 10 minutes. It is an 18-item self-report measure in which parents respond to statements about their typical relationship with their child. The possible range of the PSS is 18 (low stress) to 90 (high stress).
Respondents indicate how much they agree or disagree to each of the 18 statements. Responses are scored as follows:Strongly disagree = 1,Disagree = 2, Undecided = 3, Agree = 4, Strongly agree = 5
Measured: Immediately after the sign of the consent (T0)
Parental Stress Scale
The Parental Stress Scale (PSS) was created in 1995 to measure stress unique to parenting and captures both the joys and demands of parenting. Each following sentences describe feelings and perceptions that relate to the experience of being a parent. The PSS is brief and can be completed in less than 10 minutes. It is an 18-item self-report measure in which parents respond to statements about their typical relationship with their child. The possible range of the PSS is 18 (low stress) to 90 (high stress).
Respondents indicate how much they agree or disagree to each of the 18 statements. Responses are scored as follows:Strongly disagree = 1,Disagree = 2, Undecided = 3, Agree = 4, Strongly agree = 5
Measured: Six month after the use of coquille device (T1)
Parental Stress Scale
The Parental Stress Scale (PSS) was created in 1995 to measure stress unique to parenting and captures both the joys and demands of parenting. Each following sentences describe feelings and perceptions that relate to the experience of being a parent. The PSS is brief and can be completed in less than 10 minutes. It is an 18-item self-report measure in which parents respond to statements about their typical relationship with their child. The possible range of the PSS is 18 (low stress) to 90 (high stress).
Respondents indicate how much they agree or disagree to each of the 18 statements. Responses are scored as follows:Strongly disagree = 1,Disagree = 2, Undecided = 3, Agree = 4, Strongly agree = 5
Measured: Six month after the follow up (T2)
Ways of Coping Checklist
The Ways of Coping Checklist (WCCL; Folkman \& Lazarus, 1980) is a checklist of 68 items describing a broad range of behavioral and cognitive coping strategies that an individ- ual might use in a specific stressful episode.They include items from the domains of defensive coping (e.g., avoidance, intellectualization, isolation, suppression), information-seeking, problem- solving, palliation, inhibition of action, direct action, and magical thinking. The checklist is binary, yes or no, and is always answered with a specific stressful event in mind. The items on the WCCL were classified into two categories: problem- focused and emotion-focused.
Measured: Immediately after the sign of the consent (T0)
Ways of Coping Checklist
The Ways of Coping Checklist (WCCL; Folkman \& Lazarus, 1980) is a checklist of 68 items describing a broad range of behavioral and cognitive coping strategies that an individ- ual might use in a specific stressful episode.They include items from the domains of defensive coping (e.g., avoidance, intellectualization, isolation, suppression), information-seeking, problem- solving, palliation, inhibition of action, direct action, and magical thinking. The checklist is binary, yes or no, and is always answered with a specific stressful event in mind. The items on the WCCL were classified into two categories: problem- focused and emotion-focused.
Measured: Six month after the use of coquille device (T1)
Ways of Coping Checklist
The Ways of Coping Checklist (WCCL; Folkman \& Lazarus, 1980) is a checklist of 68 items describing a broad range of behavioral and cognitive coping strategies that an individ- ual might use in a specific stressful episode.They include items from the domains of defensive coping (e.g., avoidance, intellectualization, isolation, suppression), information-seeking, problem- solving, palliation, inhibition of action, direct action, and magical thinking. The checklist is binary, yes or no, and is always answered with a specific stressful event in mind. The items on the WCCL were classified into two categories: problem- focused and emotion-focused.
Measured: Six month after the follow up (T2)
sense of coherence scale
The Sense of Coherence (SOC) scale evaluates how people perceive life and identifies how they use their resources of resistance to maintain and develop their health.This scale is written by Antonovsky in 1987. There is 13 items. For eachs items, you have to choose between Never, rarely, often, frequently and always.
Measured: Immediately after the sign of the consent (T0)
sense of coherence scale
The Sense of Coherence (SOC) scale evaluates how people perceive life and identifies how they use their resources of resistance to maintain and develop their health.This scale is written by Antonovsky in 1987. There is 13 items. For eachs items, you have to choose between Never, rarely, often, frequently and always.
Measured: Six month after the use of coquille device (T1)
sense of coherence scale
The Sense of Coherence (SOC) scale evaluates how people perceive life and identifies how they use their resources of resistance to maintain and develop their health.This scale is written by Antonovsky in 1987. There is 13 items. For eachs items, you have to choose between Never, rarely, often, frequently and always.
Measured: Six month after the follow up (T2)
Parent Sense of Competency Scale (PSOC)
The Parenting Sense of Competency Scale (PSOC) was developed by Gibaud-Wallston as part of her PhD dissertation and presented at the American Psychological Association by Gibaud-Wallston and Wandersman in 1978. The PSOC is a 17 item scale, with 2 subscales. Each item is rated on a 6 point Likert scale anchored by 1 = "Strongly Disagree" and 6 = "Strongly Agree".
Nine (9) items (#s 2, 3, 4, 5, 8, 9, 12, 14, and 16) on the PSOC are reverse coded.
Measured: Immediately after the sign of the consent (T0)
Parent Sense of Competency Scale (PSOC)
The Parenting Sense of Competency Scale (PSOC) was developed by Gibaud-Wallston as part of her PhD dissertation and presented at the American Psychological Association by Gibaud-Wallston and Wandersman in 1978. The PSOC is a 17 item scale, with 2 subscales. Each item is rated on a 6 point Likert scale anchored by 1 = "Strongly Disagree" and 6 = "Strongly Agree".
Nine (9) items (#s 2, 3, 4, 5, 8, 9, 12, 14, and 16) on the PSOC are reverse coded.
Measured: Six month after the use of coquille device (T1)
Parent Sense of Competency Scale (PSOC)
The Parenting Sense of Competency Scale (PSOC) was developed by Gibaud-Wallston as part of her PhD dissertation and presented at the American Psychological Association by Gibaud-Wallston and Wandersman in 1978. The PSOC is a 17 item scale, with 2 subscales. Each item is rated on a 6 point Likert scale anchored by 1 = "Strongly Disagree" and 6 = "Strongly Agree".
Nine (9) items (#s 2, 3, 4, 5, 8, 9, 12, 14, and 16) on the PSOC are reverse coded.
Measured: Six month after the follow up (T2)
Multidimensional Scale of Perceived Social Support (MSPSS)
The Multidimensional Scale of Perceived Social Support (MSPSS) is a 12-item questionnaire to identify an individual's perceived level of social support with family, friends, and significant others.
Measured: Immediately after the sign of the consent (T0)
Multidimensional Scale of Perceived Social Support (MSPSS)
The Multidimensional Scale of Perceived Social Support (MSPSS) is a 12-item questionnaire to identify an individual's perceived level of social support with family, friends, and significant others.
Measured: Six month after the use of coquille device (T1)
Multidimensional Scale of Perceived Social Support (MSPSS)
The Multidimensional Scale of Perceived Social Support (MSPSS) is a 12-item questionnaire to identify an individual's perceived level of social support with family, friends, and significant others.
Measured: Six month after the follow up (T2)
The Marlowe-Crowne Social Desirability Scale (MC-SDS)
The social desirability scale is a 33-items self-report questionnaire that assesses whether or not respondents are concerned with social approval. The scale was created by Douglas P. Crowne and David Marlowe in 1960 in an effort to measure social desirability bias, which is considered one of the most common biases affecting survey research.A high number of socially desirable responses might indicate that the respondent is generally concerned with social approval and conforming to societal conventions, while a low score might indicate that the respondent is less concerned with such things and is more willing to answer survey questions truthfully and representing themselves accurately.
Measured: Immediately after the sign of the consent (T0)
The Marlowe-Crowne Social Desirability Scale (MC-SDS)
The social desirability scale is a 33-items self-report questionnaire that assesses whether or not respondents are concerned with social approval. The scale was created by Douglas P. Crowne and David Marlowe in 1960 in an effort to measure social desirability bias, which is considered one of the most common biases affecting survey research.A high number of socially desirable responses might indicate that the respondent is generally concerned with social approval and conforming to societal conventions, while a low score might indicate that the respondent is less concerned with such things and is more willing to answer survey questions truthfully and representing themselves accurately.
Measured: Six month after the use of coquille device (T1)
The Marlowe-Crowne Social Desirability Scale (MC-SDS)
The social desirability scale is a 33-items self-report questionnaire that assesses whether or not respondents are concerned with social approval. The scale was created by Douglas P. Crowne and David Marlowe in 1960 in an effort to measure social desirability bias, which is considered one of the most common biases affecting survey research.A high number of socially desirable responses might indicate that the respondent is generally concerned with social approval and conforming to societal conventions, while a low score might indicate that the respondent is less concerned with such things and is more willing to answer survey questions truthfully and representing themselves accurately.
Measured: Six month after the follow up (T2)
Aberrant Behavior Checklist
The Aberrant Behavior Checklist consists of 58 questions across 5 different domains: (a) irritability, (b) social withdrawal, (c) stereotypic behavior, (d) hyperactivity/noncompliance, and (e) inappropriate speech. The rater has to answer each of the 58 questions using a 4-point Likert scale. A score of a "0" means the behavior is not a problem, a score of a "1" means slight problem, a score of a "2" means a serious problem, and a "3" means a severe problem.
Measured: Immediately after the sign of the consent (T0)
Aberrant Behavior Checklist
The Aberrant Behavior Checklist consists of 58 questions across 5 different domains: (a) irritability, (b) social withdrawal, (c) stereotypic behavior, (d) hyperactivity/noncompliance, and (e) inappropriate speech. The rater has to answer each of the 58 questions using a 4-point Likert scale. A score of a "0" means the behavior is not a problem, a score of a "1" means slight problem, a score of a "2" means a serious problem, and a "3" means a severe problem.
Measured: Six month after the use of coquille device (T1)
Aberrant Behavior Checklist
The Aberrant Behavior Checklist consists of 58 questions across 5 different domains: (a) irritability, (b) social withdrawal, (c) stereotypic behavior, (d) hyperactivity/noncompliance, and (e) inappropriate speech. The rater has to answer each of the 58 questions using a 4-point Likert scale. A score of a "0" means the behavior is not a problem, a score of a "1" means slight problem, a score of a "2" means a serious problem, and a "3" means a severe problem.
Measured: Six month after the follow up (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start29 Nov 2024
- Primary completion1 Apr 2029 (estimated)
- Study completion1 Jun 2029 (estimated)
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.
- 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
- Model description
- In this context, an innovative early-stage device was launched in the fall of 2022 at the Coquille unit of the Ville Evrard Public Health Establishment (EPSVE), for children under 30 months with Autism Spectrum Disorder and their families. This six-month therapeutic device in day hospital includes: * 22 TMF sessions, * four two-family observation sessions, * three sessions of four unique family sessions, * the possibilities of individual targeted intervention in case of need estimated by families and/or caregivers.
- Masking
- None (open label)
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre hospitalier de Ville-Evrard, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pierre LECARPENTIER, Centre hospitalier de Ville-Evrard, France
- Investigators
- Pierre LECARPENTIER, MBBS, Principal investigator, EPS VILLE EVRARD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06867783
- Sponsor's protocol ID
- 10477M-COQUILLE
- Acronym
- coquille
- Status last verified
- Mar 2025
- First submitted
- 7 Jan 2025
- Last updated
- 10 Mar 2025
- 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 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVALUATION OF EARLY FAMILY AND MULTIFAMILY INTERVENTION FOR YOUNG CHILDREN WITH AUTISM SPECTRUM DISORDERS
- ClinicalTrials.gov ID
- NCT06867783
- Acronym / sponsor ID
- coquille / 10477M-COQUILLE
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism Spectrum Disorder - coquille device
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Centre hospitalier de Ville-Evrard, FranceUniversity, hospital or other
- Study start
- 29 Nov 2024 (actual)
- Primary completion
- 1 Apr 2029 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 10 Mar 2025 (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.
Collaborative early management of children under 30 months with autism spectrum disorder and their families in an ambulatory child psychiatry unit.
Detailed description
Early intervention in Autism Spectrum Disorder (ASD) is now considered a priority. An approach that targets both child disorders and parental distress, and supports the skills of parents, is desirable. Yet there is no early intervention by the ASD involving parents and targeting both child functioning and parenting skills specifically.
Our objective is to evaluate quantitatively and qualitatively the collaborative family support system for ASD "Coquille". This scheme combines the development of a personalized care project based on parents' priorities, an intensive single-family parent-child follow-up and a group of multi-family therapy , over a total period of 6 months. Our main hypothesis is the significant decrease in behavioral disorders of children, evaluated by CARS, following the Coquille device. Our secondary hypotheses concern the evolution of parental dimensions following the device (sense of coherence, parental skills, parental stress, coping strategies and social support). We assume that these dimensions will change as a result of the scheme, and that they will be maintained in the medium term, six months after Coquille. A semi-structured interview will qualitatively explore the dimensions related to family resources, before and after the follow-up and in the medium term. This will also allow the mother to collect experience of the device.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- In this context, an innovative early-stage device was launched in the fall of 2022 at the Coquille unit of the Ville Evrard Public Health Establishment (EPSVE), for children under 30 months with Autism Spectrum Disorder and their families. This six-month therapeutic device in day hospital includes: * 22 TMF sessions, * four two-family observation sessions, * three sessions of four unique family sessions, * the possibilities of individual targeted intervention in case of need estimated by families and/or caregivers.
| Arm | Type | Receives |
|---|---|---|
| coquille device | Other | Device: coquillecollaborative family support scheme aimed at improving family functioning and child behaviour |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 years and over
- French language spoken and written by the parent
- Free and informed consent form , initialled and signed by the parent
- Child under 30 months of age at time of inclusion, diagnosed with autism spectrum disorder
- Total CARS score greater than or equal to 30
Key exclusion criteria (4 listed)
- Any acute, somatic or psychiatric clinical condition of the mother not compatible with therapeutic intervention.
- Current engagement in an interventional research protocol
- Mother under protection of justice, guardianship or enhanced curatorship
- Mother no longer having parental authority
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 |
|---|---|---|
| coquilleModalities: Elaboration of the personalized care project, follow-up parents-child single family, multi-family therapy (MFT). Frequency: MFT weekly, bi-familial observation weekly for one month, single-parent child-parent monitoring weekly for five months, MFT father-child bimonthly for six months, three co-parents, three child psychiatric consultations to develop the personalized collaborative care project | Device | coquille device |
Primary outcome
Childhood Autism Rating, Scale, CARS
Time frame: It is done before the sign of the consent (T-1),
CARS works by rating your child's behavior, characteristics, and abilities against the expected developmental growth of a typical child.It is done by your primary healthcare provider, a teacher, or a parent by rating the child's behaviors from 1 to 4. 1 being normal for your child's age, 2 for mildly abnormal, 3 for moderately abnormal, and 4 as severely abnormal. Scores range from 15 to 60 with 30 being the cutoff rate for a diagnosis of mild autism. Scores 30-37 indicate mild to moderate autism, while scores between 38 and 60 are characterized as severe autism.
Childhood Autism Rating, Scale, CARS
Time frame: Six month after the use of coquille device (T1)
CARS works by rating your child's behavior, characteristics, and abilities against the expected developmental growth of a typical child.It is done by your primary healthcare provider, a teacher, or a parent by rating the child's behaviors from 1 to 4. 1 being normal for your child's age, 2 for mildly abnormal, 3 for moderately abnormal, and 4 as severely abnormal. Scores range from 15 to 60 with 30 being the cutoff rate for a diagnosis of mild autism. Scores 30-37 indicate mild to moderate autism, while scores between 38 and 60 are characterized as severe autism.
Childhood Autism Rating, Scale, CARS
Time frame: Six month after the follow up (T2)
CARS works by rating your child's behavior, characteristics, and abilities against the expected developmental growth of a typical child.It is done by your primary healthcare provider, a teacher, or a parent by rating the child's behaviors from 1 to 4. 1 being normal for your child's age, 2 for mildly abnormal, 3 for moderately abnormal, and 4 as severely abnormal. Scores range from 15 to 60 with 30 being the cutoff rate for a diagnosis of mild autism. Scores 30-37 indicate mild to moderate autism, while scores between 38 and 60 are characterized as severe autism.
Sociodemographic and lifestyle
Time frame: Immediately after the sign of the consent (T0)
The socio-demographic questionnaire contains 4 items: Socio-demographic criteria (gender, date of birth, level of education, marital status and number of children), diet, screen, and sleep.
Sociodemographic and lifestyle
Time frame: Six month after the use of coquille device (T1)
The socio-demographic questionnaire contains 4 items: Socio-demographic criteria (gender, date of birth, level of education, marital status and number of children), diet, screen, and sleep.
Sociodemographic and lifestyle
Time frame: Six month after the follow up (T2)
The socio-demographic questionnaire contains 4 items: Socio-demographic criteria (gender, date of birth, level of education, marital status and number of children), diet, screen, and sleep.
Parental Stress Scale
Time frame: Immediately after the sign of the consent (T0)
The Parental Stress Scale (PSS) was created in 1995 to measure stress unique to parenting and captures both the joys and demands of parenting. Each following sentences describe feelings and perceptions that relate to the experience of being a parent. The PSS is brief and can be completed in less than 10 minutes. It is an 18-item self-report measure in which parents respond to statements about their typical relationship with their child. The possible range of the PSS is 18 (low stress) to 90 (high stress). Respondents indicate how much they agree or disagree to each of the 18 statements. Responses are scored as follows:Strongly disagree = 1,Disagree = 2, Undecided = 3, Agree = 4, Strongly agree = 5
Parental Stress Scale
Time frame: Six month after the use of coquille device (T1)
The Parental Stress Scale (PSS) was created in 1995 to measure stress unique to parenting and captures both the joys and demands of parenting. Each following sentences describe feelings and perceptions that relate to the experience of being a parent. The PSS is brief and can be completed in less than 10 minutes. It is an 18-item self-report measure in which parents respond to statements about their typical relationship with their child. The possible range of the PSS is 18 (low stress) to 90 (high stress). Respondents indicate how much they agree or disagree to each of the 18 statements. Responses are scored as follows:Strongly disagree = 1,Disagree = 2, Undecided = 3, Agree = 4, Strongly agree = 5
Parental Stress Scale
Time frame: Six month after the follow up (T2)
The Parental Stress Scale (PSS) was created in 1995 to measure stress unique to parenting and captures both the joys and demands of parenting. Each following sentences describe feelings and perceptions that relate to the experience of being a parent. The PSS is brief and can be completed in less than 10 minutes. It is an 18-item self-report measure in which parents respond to statements about their typical relationship with their child. The possible range of the PSS is 18 (low stress) to 90 (high stress). Respondents indicate how much they agree or disagree to each of the 18 statements. Responses are scored as follows:Strongly disagree = 1,Disagree = 2, Undecided = 3, Agree = 4, Strongly agree = 5
Ways of Coping Checklist
Time frame: Immediately after the sign of the consent (T0)
The Ways of Coping Checklist (WCCL; Folkman \& Lazarus, 1980) is a checklist of 68 items describing a broad range of behavioral and cognitive coping strategies that an individ- ual might use in a specific stressful episode.They include items from the domains of defensive coping (e.g., avoidance, intellectualization, isolation, suppression), information-seeking, problem- solving, palliation, inhibition of action, direct action, and magical thinking. The checklist is binary, yes or no, and is always answered with a specific stressful event in mind. The items on the WCCL were classified into two categories: problem- focused and emotion-focused.
Ways of Coping Checklist
Time frame: Six month after the use of coquille device (T1)
The Ways of Coping Checklist (WCCL; Folkman \& Lazarus, 1980) is a checklist of 68 items describing a broad range of behavioral and cognitive coping strategies that an individ- ual might use in a specific stressful episode.They include items from the domains of defensive coping (e.g., avoidance, intellectualization, isolation, suppression), information-seeking, problem- solving, palliation, inhibition of action, direct action, and magical thinking. The checklist is binary, yes or no, and is always answered with a specific stressful event in mind. The items on the WCCL were classified into two categories: problem- focused and emotion-focused.
Ways of Coping Checklist
Time frame: Six month after the follow up (T2)
The Ways of Coping Checklist (WCCL; Folkman \& Lazarus, 1980) is a checklist of 68 items describing a broad range of behavioral and cognitive coping strategies that an individ- ual might use in a specific stressful episode.They include items from the domains of defensive coping (e.g., avoidance, intellectualization, isolation, suppression), information-seeking, problem- solving, palliation, inhibition of action, direct action, and magical thinking. The checklist is binary, yes or no, and is always answered with a specific stressful event in mind. The items on the WCCL were classified into two categories: problem- focused and emotion-focused.
sense of coherence scale
Time frame: Immediately after the sign of the consent (T0)
The Sense of Coherence (SOC) scale evaluates how people perceive life and identifies how they use their resources of resistance to maintain and develop their health.This scale is written by Antonovsky in 1987. There is 13 items. For eachs items, you have to choose between Never, rarely, often, frequently and always.
sense of coherence scale
Time frame: Six month after the use of coquille device (T1)
The Sense of Coherence (SOC) scale evaluates how people perceive life and identifies how they use their resources of resistance to maintain and develop their health.This scale is written by Antonovsky in 1987. There is 13 items. For eachs items, you have to choose between Never, rarely, often, frequently and always.
sense of coherence scale
Time frame: Six month after the follow up (T2)
The Sense of Coherence (SOC) scale evaluates how people perceive life and identifies how they use their resources of resistance to maintain and develop their health.This scale is written by Antonovsky in 1987. There is 13 items. For eachs items, you have to choose between Never, rarely, often, frequently and always.
Parent Sense of Competency Scale (PSOC)
Time frame: Immediately after the sign of the consent (T0)
The Parenting Sense of Competency Scale (PSOC) was developed by Gibaud-Wallston as part of her PhD dissertation and presented at the American Psychological Association by Gibaud-Wallston and Wandersman in 1978. The PSOC is a 17 item scale, with 2 subscales. Each item is rated on a 6 point Likert scale anchored by 1 = "Strongly Disagree" and 6 = "Strongly Agree". Nine (9) items (#s 2, 3, 4, 5, 8, 9, 12, 14, and 16) on the PSOC are reverse coded.
Parent Sense of Competency Scale (PSOC)
Time frame: Six month after the use of coquille device (T1)
The Parenting Sense of Competency Scale (PSOC) was developed by Gibaud-Wallston as part of her PhD dissertation and presented at the American Psychological Association by Gibaud-Wallston and Wandersman in 1978. The PSOC is a 17 item scale, with 2 subscales. Each item is rated on a 6 point Likert scale anchored by 1 = "Strongly Disagree" and 6 = "Strongly Agree". Nine (9) items (#s 2, 3, 4, 5, 8, 9, 12, 14, and 16) on the PSOC are reverse coded.
Parent Sense of Competency Scale (PSOC)
Time frame: Six month after the follow up (T2)
The Parenting Sense of Competency Scale (PSOC) was developed by Gibaud-Wallston as part of her PhD dissertation and presented at the American Psychological Association by Gibaud-Wallston and Wandersman in 1978. The PSOC is a 17 item scale, with 2 subscales. Each item is rated on a 6 point Likert scale anchored by 1 = "Strongly Disagree" and 6 = "Strongly Agree". Nine (9) items (#s 2, 3, 4, 5, 8, 9, 12, 14, and 16) on the PSOC are reverse coded.
Multidimensional Scale of Perceived Social Support (MSPSS)
Time frame: Immediately after the sign of the consent (T0)
The Multidimensional Scale of Perceived Social Support (MSPSS) is a 12-item questionnaire to identify an individual's perceived level of social support with family, friends, and significant others.
Multidimensional Scale of Perceived Social Support (MSPSS)
Time frame: Six month after the use of coquille device (T1)
The Multidimensional Scale of Perceived Social Support (MSPSS) is a 12-item questionnaire to identify an individual's perceived level of social support with family, friends, and significant others.
Multidimensional Scale of Perceived Social Support (MSPSS)
Time frame: Six month after the follow up (T2)
The Multidimensional Scale of Perceived Social Support (MSPSS) is a 12-item questionnaire to identify an individual's perceived level of social support with family, friends, and significant others.
The Marlowe-Crowne Social Desirability Scale (MC-SDS)
Time frame: Immediately after the sign of the consent (T0)
The social desirability scale is a 33-items self-report questionnaire that assesses whether or not respondents are concerned with social approval. The scale was created by Douglas P. Crowne and David Marlowe in 1960 in an effort to measure social desirability bias, which is considered one of the most common biases affecting survey research.A high number of socially desirable responses might indicate that the respondent is generally concerned with social approval and conforming to societal conventions, while a low score might indicate that the respondent is less concerned with such things and is more willing to answer survey questions truthfully and representing themselves accurately.
The Marlowe-Crowne Social Desirability Scale (MC-SDS)
Time frame: Six month after the use of coquille device (T1)
The social desirability scale is a 33-items self-report questionnaire that assesses whether or not respondents are concerned with social approval. The scale was created by Douglas P. Crowne and David Marlowe in 1960 in an effort to measure social desirability bias, which is considered one of the most common biases affecting survey research.A high number of socially desirable responses might indicate that the respondent is generally concerned with social approval and conforming to societal conventions, while a low score might indicate that the respondent is less concerned with such things and is more willing to answer survey questions truthfully and representing themselves accurately.
The Marlowe-Crowne Social Desirability Scale (MC-SDS)
Time frame: Six month after the follow up (T2)
The social desirability scale is a 33-items self-report questionnaire that assesses whether or not respondents are concerned with social approval. The scale was created by Douglas P. Crowne and David Marlowe in 1960 in an effort to measure social desirability bias, which is considered one of the most common biases affecting survey research.A high number of socially desirable responses might indicate that the respondent is generally concerned with social approval and conforming to societal conventions, while a low score might indicate that the respondent is less concerned with such things and is more willing to answer survey questions truthfully and representing themselves accurately.
Aberrant Behavior Checklist
Time frame: Immediately after the sign of the consent (T0)
The Aberrant Behavior Checklist consists of 58 questions across 5 different domains: (a) irritability, (b) social withdrawal, (c) stereotypic behavior, (d) hyperactivity/noncompliance, and (e) inappropriate speech. The rater has to answer each of the 58 questions using a 4-point Likert scale. A score of a "0" means the behavior is not a problem, a score of a "1" means slight problem, a score of a "2" means a serious problem, and a "3" means a severe problem.
Aberrant Behavior Checklist
Time frame: Six month after the use of coquille device (T1)
The Aberrant Behavior Checklist consists of 58 questions across 5 different domains: (a) irritability, (b) social withdrawal, (c) stereotypic behavior, (d) hyperactivity/noncompliance, and (e) inappropriate speech. The rater has to answer each of the 58 questions using a 4-point Likert scale. A score of a "0" means the behavior is not a problem, a score of a "1" means slight problem, a score of a "2" means a serious problem, and a "3" means a severe problem.
Aberrant Behavior Checklist
Time frame: Six month after the follow up (T2)
The Aberrant Behavior Checklist consists of 58 questions across 5 different domains: (a) irritability, (b) social withdrawal, (c) stereotypic behavior, (d) hyperactivity/noncompliance, and (e) inappropriate speech. The rater has to answer each of the 58 questions using a 4-point Likert scale. A score of a "0" means the behavior is not a problem, a score of a "1" means slight problem, a score of a "2" means a serious problem, and a "3" means a severe problem.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Individual participant dataSharing planned: No
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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.
Pierre LECARPENTIER, MBBS principal investigator
EPS VILLE EVRARD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing coquille in people with Autism Spectrum Disorder, run by Centre hospitalier de Ville-Evrard, France at 1 site in France.
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 6 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 10 Mar 2025. 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 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?
This study is still under way. Results are not available in the source record yet.
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?
Childhood Autism Rating, Scale, CARS (time frame: It is done before the sign of the consent (T-1),). The study lists 27 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 10 Mar 2025.