EVALUATION for YOUNG CHILDREN with AUTISM SPECTRUM DISORDERS (coquille)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Device: coquille

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 Type: Interventional
• Enrollment (Estimated): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Neuilly-sur-Marne, France, 93330
    • EPS Ville Evrard

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria for the mother and the child:

• 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

Exclusion Criteria for the mother only:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: coquille device; collaborative family support scheme aimed at improving family functioning and child behaviour

Device: coquille; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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	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	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	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	Six month after the follow up (T2)

Collaborators and Investigators

• Sponsor: Centre hospitalier de Ville-Evrard, France
• Investigators: Principal Investigator: Pierre LECARPENTIER, MBBS, EPS Ville Evrard

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2024
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: January 7, 2025
• First Submitted That Met QC Criteria: March 5, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 5, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Autism Spectrum Disorder - coquille device
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Autism Spectrum Disorder; Autistic Disorder; Child Development Disorders, Pervasive
• Other Study ID Numbers: 10477M-COQUILLE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No