EVALUATION FOR YOUNG CHILDREN WITH AUTISM SPECTRUM DISORDERS

NCT06867783 | Active Not Recruiting

• 1 other identifier: 10477M-COQUILLE
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

Collaborative early management of children under 30 months with autism spectrum disorder and their families in an ambulatory child psychiatry unit.

Conditions

Autism Spectrum Disorder

Keywords

Autism Spectrum Disorder - coquille device

Outcome Measures

Primary Outcomes (27)

• 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)

Study Arms (1)

coquille device

OTHER

collaborative family support scheme aimed at improving family functioning and child behaviour

Device: coquille

Interventions

coquille DEVICE

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

coquille device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years and over
• French language spoken and written by the parent
• Free and informed consent form , initialled and signed by the parent
• Total CARS score greater than or equal to 30
• Free and informed consent form, initialled and signed by legal representatives

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre hospitalier de Ville-Evrard, France: lead

Study Sites (1)

Eps Ville Evrard

Neuilly-sur-Marne, 93330, France

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Pierre LECARPENTIER, MBBS

  EPS VILLE EVRARD

  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: PRINCIPAL INVESTIGATOR
• PI Title: MBBS, psychiatrist and investigator

Model Details: 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.

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: March 10, 2025
• Study Start: November 29, 2024
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: March 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)