NCT Number: NCT05726708
The goal of this study is to evaluate the impact of a parental coaching based on E-Learning (EL), intended for parents of children with autism spectrum disorder (ASD). Population: parents of young children (2 to 4 years old) with an ASD diagnosis.
The main questions that our study will answer are:
* Has parental coaching via E-Learning a significant impact compared to no coaching? * If so, is that impact comparable to standard parental coaching such as PACT?
The impact will be evaluated in three domains:
* Child development: behavior, sleep, eating behavior * Parental competences: stress, coping, feeling of parental competencies * Parent-child interaction: communication, visual attention
The investigators will compare 3 groups:
1. ASD children whose parents will follow a parental coaching via E-learning, 2. ASD children whose parents will follow a standard parental coaching (PACT) 3. ASD children whose parents will not follow any specific coaching program
Interested in participating?
Request Info24 month–48 month
All sexes
Interventional
Not applicable
Lausanne, 1011, Switzerland
Location status: Recruiting
Borja Rodriguez-Herreros
SUB_INVESTIGATOR
Chloe Peter
CONTACT
Chloé Peter
SUB_INVESTIGATOR
Evelyne Antonietti
SUB_INVESTIGATOR
Joana Almeido Osorio
SUB_INVESTIGATOR
Nadia Chabane
PRINCIPAL_INVESTIGATOR
Nadia Chabane, Pr
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
On line modules of coaching for parents
Time frame: Month 0
DCMA is a measure of the natural flowing dyadic communication interaction between parent and child in a free play context. It was originally designed to capture aspects of communication in young children with autism and aspects of the parent communication style that are often targeted in communication-focussed interventions. It Is grounded in the theory and research on pragmatic language development in children, specifically in children with autism. DCMA involves video-recording the parent and child playing together in a natural way using a standard set of toys. The interaction is then coded from video-tape and three levels of the interaction are observed:
Time frame: Month 6
DCMA is a measure of the natural flowing dyadic communication interaction between parent and child in a free play context. It was originally designed to capture aspects of communication in young children with autism and aspects of the parent communication style that are often targeted in communication-focussed interventions. It Is grounded in the theory and research on pragmatic language development in children, specifically in children with autism. DCMA involves video-recording the parent and child playing together in a natural way using a standard set of toys. The interaction is then coded from video-tape and three levels of the interaction are observed:
Time frame: Month 12
DCMA is a measure of the natural flowing dyadic communication interaction between parent and child in a free play context. It was originally designed to capture aspects of communication in young children with autism and aspects of the parent communication style that are often targeted in communication-focussed interventions. It Is grounded in the theory and research on pragmatic language development in children, specifically in children with autism. DCMA involves video-recording the parent and child playing together in a natural way using a standard set of toys. The interaction is then coded from video-tape and three levels of the interaction are observed:
Time frame: Month 0
BOSCC is a treatment response measure of autism spectrum disorder (ASD) symptoms. The BOSCC is a behavioral coding scheme that is applied to 10-12 min videotaped social/play interactions between a child and a researcher or caregiver (play partner). The coding scheme was developed by expanding items from the Autism Diagnostic Observation Schedule (ADOS), to quantify more nuanced variation in ASD symptoms.
Time frame: Month 6
BOSCC is a treatment response measure of autism spectrum disorder (ASD) symptoms. The BOSCC is a behavioral coding scheme that is applied to 10-12 min videotaped social/play interactions between a child and a researcher or caregiver (play partner). The coding scheme was developed by expanding items from the Autism Diagnostic Observation Schedule (ADOS), to quantify more nuanced variation in ASD symptoms.
Time frame: Month 12
BOSCC is a treatment response measure of autism spectrum disorder (ASD) symptoms. The BOSCC is a behavioral coding scheme that is applied to 10-12 min videotaped social/play interactions between a child and a researcher or caregiver (play partner). The coding scheme was developed by expanding items from the Autism Diagnostic Observation Schedule (ADOS), to quantify more nuanced variation in ASD symptoms.
Time frame: Month 0
Head-mounted Eye tracking system to record eye movements during Dyadic Communication Measure for Autism (DCMA) and Brief Observation of Social Communication Change (BOSCC). Head-mounted eye trackers not only capture the child's view of their environment, but also track where they are looking in first person, at all times, allowing us to study gaze in more naturalistic situations. In particular, wearable eye trackers improve the construct validity of developmentally important concepts, such as visual object experiences and social attention, in ways that would be impossible with screen-based eye trackers. The investigators will measure the percentage of synchronous communication acts with the parents and professionals.
Time frame: Month 6
Head-mounted Eye tracking system to record eye movements during Dyadic Communication Measure for Autism (DCMA) and Brief Observation of Social Communication Change (BOSCC). Head-mounted eye trackers not only capture the child's view of their environment, but also track where they are looking in first person, at all times, allowing us to study gaze in more naturalistic situations. In particular, wearable eye trackers improve the construct validity of developmentally important concepts, such as visual object experiences and social attention, in ways that would be impossible with screen-based eye trackers. The investigators will measure the percentage of synchronous communication acts with the parents and professionals.
Time frame: Month 12
Head-mounted Eye tracking system to record eye movements during Dyadic Communication Measure for Autism (DCMA) and Brief Observation of Social Communication Change (BOSCC). Head-mounted eye trackers not only capture the child's view of their environment, but also track where they are looking in first person, at all times, allowing us to study gaze in more naturalistic situations. In particular, wearable eye trackers improve the construct validity of developmentally important concepts, such as visual object experiences and social attention, in ways that would be impossible with screen-based eye trackers. The investigators will measure the percentage of synchronous communication acts with the parents and professionals.
Time frame: Month 0
The Mullen Scales of Early Learning (MSEL) is a standardized assessment commonly used in clinical psychology as a developmental measure of cognitive development in children 2 to 5½ years of age. The MSEL is organized into 5 subscales: (a) gross motor, (b) fine motor, (c) visual reception (or non-verbal problem solving), (d) receptive language, and (e) expressive language. An early learning composite score can be derived from fine motor, visual reception, receptive language, and expressive language scales. For young children this early learning composite score is considered equivalent to a more traditional intelligence quotient score or a developmental standard score. Each subscale is standardized to calculate a standard score, percentile and age-equivalent score. The maximum achievable raw score per scale is 50 for the visual reception scale, 49 for the fine motor scale, 48 for the receptive language scale and 50 for the expressive language scale. Higher scores mean a better outcome.
Time frame: Month 6
The Mullen Scales of Early Learning (MSEL) is a standardized assessment commonly used in clinical psychology as a developmental measure of cognitive development in children 2 to 5½ years of age. The MSEL is organized into 5 subscales: (a) gross motor, (b) fine motor, (c) visual reception (or non-verbal problem solving), (d) receptive language, and (e) expressive language. An early learning composite score can be derived from fine motor, visual reception, receptive language, and expressive language scales. For young children this early learning composite score is considered equivalent to a more traditional intelligence quotient score or a developmental standard score. Each subscale is standardized to calculate a standard score, percentile and age-equivalent score. The maximum achievable raw score per scale is 50 for the visual reception scale, 49 for the fine motor scale, 48 for the receptive language scale and 50 for the expressive language scale. Higher scores mean a better outcome.
Time frame: Month 12
The Mullen Scales of Early Learning (MSEL) is a standardized assessment commonly used in clinical psychology as a developmental measure of cognitive development in children 2 to 5½ years of age. The MSEL is organized into 5 subscales: (a) gross motor, (b) fine motor, (c) visual reception (or non-verbal problem solving), (d) receptive language, and (e) expressive language. An early learning composite score can be derived from fine motor, visual reception, receptive language, and expressive language scales. For young children this early learning composite score is considered equivalent to a more traditional intelligence quotient score or a developmental standard score. Each subscale is standardized to calculate a standard score, percentile and age-equivalent score. The maximum achievable raw score per scale is 50 for the visual reception scale, 49 for the fine motor scale, 48 for the receptive language scale and 50 for the expressive language scale. Higher scores mean a better outcome.
Time frame: Month 0
CEBQ is a 35-item parent-report questionnaire assessing eating style in children. Eating style is assessed on eight scales: food responsiveness (4 items), enjoyment of food (4 items), emotional overeating (4 items), desire to drink (3 items), satiety responsiveness (5 items), slowness in eating (4 items), and emotional undereating (4 items), and fussiness (7 items). Informants rate the frequency of their child's behaviors and experiences on a 5-point scale: 1 = never, 2 = rarely, 3 = sometimes, 4 = often, 5 = always.
Time frame: Month 6
CEBQ is a 35-item parent-report questionnaire assessing eating style in children. Eating style is assessed on eight scales: food responsiveness (4 items), enjoyment of food (4 items), emotional overeating (4 items), desire to drink (3 items), satiety responsiveness (5 items), slowness in eating (4 items), and emotional undereating (4 items), and fussiness (7 items). Informants rate the frequency of their child's behaviors and experiences on a 5-point scale: 1 = never, 2 = rarely, 3 = sometimes, 4 = often, 5 = always.
Time frame: Month 12
CEBQ is a 35-item parent-report questionnaire assessing eating style in children. Eating style is assessed on eight scales: food responsiveness (4 items), enjoyment of food (4 items), emotional overeating (4 items), desire to drink (3 items), satiety responsiveness (5 items), slowness in eating (4 items), and emotional undereating (4 items), and fussiness (7 items). Informants rate the frequency of their child's behaviors and experiences on a 5-point scale: 1 = never, 2 = rarely, 3 = sometimes, 4 = often, 5 = always.
Time frame: Month 0
The CBCL/1.5-5 obtains caregivers' ratings of 99 problem items. Items are scored on the following syndrome scales: Emotionally Reactive, Anxious/Depressed, Somatic Complaints, Withdrawn, Attention Problems, Aggressive Behavior, and Sleep Problems. Items are also scored on the following Diagnostic and Statistical Manual (DSM)-oriented scales: Affective Problems, Anxiety Problems, Pervasive Developmental Problems, Attention Deficit/Hyperactivity Problems, Stress Problems, Autism Spectrum Problems, and Oppositional Defiant Problems. According to the normative data of the CBCL, a t-score ≤ 59 indicates non-clinical symptoms, a t-score between 60 and 64 indicates that the child is at risk for problem behaviors, and a t-score ≥ 65 indicates clinical symptoms. Higher scores mean thus a worse outcome.
Time frame: Month 6
The CBCL/1.5-5 obtains caregivers' ratings of 99 problem items. Items are scored on the following syndrome scales: Emotionally Reactive, Anxious/Depressed, Somatic Complaints, Withdrawn, Attention Problems, Aggressive Behavior, and Sleep Problems. Items are also scored on the following Diagnostic and Statistical Manual (DSM)-oriented scales: Affective Problems, Anxiety Problems, Pervasive Developmental Problems, Attention Deficit/Hyperactivity Problems, Stress Problems, Autism Spectrum Problems, and Oppositional Defiant Problems. According to the normative data of the CBCL, a t-score ≤ 59 indicates non-clinical symptoms, a t-score between 60 and 64 indicates that the child is at risk for problem behaviors, and a t-score ≥ 65 indicates clinical symptoms. Higher scores mean thus a worse outcome.
Time frame: Month 12
The CBCL/1.5-5 obtains caregivers' ratings of 99 problem items. Items are scored on the following syndrome scales: Emotionally Reactive, Anxious/Depressed, Somatic Complaints, Withdrawn, Attention Problems, Aggressive Behavior, and Sleep Problems. Items are also scored on the following Diagnostic and Statistical Manual (DSM)-oriented scales: Affective Problems, Anxiety Problems, Pervasive Developmental Problems, Attention Deficit/Hyperactivity Problems, Stress Problems, Autism Spectrum Problems, and Oppositional Defiant Problems. According to the normative data of the CBCL, a t-score ≤ 59 indicates non-clinical symptoms, a t-score between 60 and 64 indicates that the child is at risk for problem behaviors, and a t-score ≥ 65 indicates clinical symptoms. Higher scores mean thus a worse outcome.
Time frame: Month 0
PSQ contains 22 symptom items that ask about snoring frequency, loud snoring, observed apneas, difficulty breathing during sleep, daytime sleepiness, inattentive or hyperactive behavior, and other pediatric sleep-related features. Subscales within the PSQ include a 4-item sleepiness scale, a 4-item snoring scale, and a 6-item in attention/hyperactivity scale. The answers are scored as "0" (symptom absent) or "1" (symptom present) and the overall score is calculated as a proportion of positive answers with a score greater or equal to 0.33 being considered predictive for sleep disordered breathing. Higher scores mean thus a worse outcome.
Time frame: Month 6
PSQ contains 22 symptom items that ask about snoring frequency, loud snoring, observed apneas, difficulty breathing during sleep, daytime sleepiness, inattentive or hyperactive behavior, and other pediatric sleep-related features. Subscales within the PSQ include a 4-item sleepiness scale, a 4-item snoring scale, and a 6-item in attention/hyperactivity scale. The answers are scored as "0" (symptom absent) or "1" (symptom present) and the overall score is calculated as a proportion of positive answers with a score greater or equal to 0.33 being considered predictive for sleep disordered breathing. Higher scores mean thus a worse outcome.
Time frame: Month 12
PSQ contains 22 symptom items that ask about snoring frequency, loud snoring, observed apneas, difficulty breathing during sleep, daytime sleepiness, inattentive or hyperactive behavior, and other pediatric sleep-related features. Subscales within the PSQ include a 4-item sleepiness scale, a 4-item snoring scale, and a 6-item in attention/hyperactivity scale. The answers are scored as "0" (symptom absent) or "1" (symptom present) and the overall score is calculated as a proportion of positive answers with a score greater or equal to 0.33 being considered predictive for sleep disordered breathing. Higher scores mean thus a worse outcome.
Time frame: Month 0
PSI is a questionnaire designed to measure the extent of stress in the parent-child relationship. This diagnostic instrument is based on the assumption that the integral stress experienced by the parent depends on certain characteristics of the child, the parent, and the parenting situation. Child stress features are measured on six scales:
Hyperactivity/Distraction, Adaptability, Reinforcement, Demands, Mood, Acceptability. Parent personality and situational variables are measured on seven scales: Depression, Sense of competence, Attachment, Marital relationship, Social isolation, Parenting health, Parenting restrictions. PSI has 36 items based on a five-point Likert scale where each value corresponds to a specific statement (1 = completely disagree; 5 = completely agree). The subscale scores range from 12 to 60, and the Total Stress score ranges from 36 to 180. The higher the score, the greater the level of parental stress.
Time frame: Month 6
PSI is a questionnaire designed to measure the extent of stress in the parent-child relationship. This diagnostic instrument is based on the assumption that the integral stress experienced by the parent depends on certain characteristics of the child, the parent, and the parenting situation. Child stress features are measured on six scales:
Hyperactivity/Distraction, Adaptability, Reinforcement, Demands, Mood, Acceptability. Parent personality and situational variables are measured on seven scales: Depression, Sense of competence, Attachment, Marital relationship, Social isolation, Parenting health, Parenting restrictions. PSI has 36 items based on a five-point Likert scale where each value corresponds to a specific statement (1 = completely disagree; 5 = completely agree). The subscale scores range from 12 to 60, and the Total Stress score ranges from 36 to 180. The higher the score, the greater the level of parental stress.
Time frame: Month 12
PSI is a questionnaire designed to measure the extent of stress in the parent-child relationship. This diagnostic instrument is based on the assumption that the integral stress experienced by the parent depends on certain characteristics of the child, the parent, and the parenting situation. Child stress features are measured on six scales:
Hyperactivity/Distraction, Adaptability, Reinforcement, Demands, Mood, Acceptability. Parent personality and situational variables are measured on seven scales: Depression, Sense of competence, Attachment, Marital relationship, Social isolation, Parenting health, Parenting restrictions. PSI has 36 items based on a five-point Likert scale where each value corresponds to a specific statement (1 = completely disagree; 5 = completely agree). The subscale scores range from 12 to 60, and the Total Stress score ranges from 36 to 180. The higher the score, the greater the level of parental stress.
Time frame: Month 0
The PSOC questionnaire is composed of 17 statements that measure the feeling of competence in the exercise of the parental role. It has two subscales: seven statements concern the feeling of efficacy and ten others, the feeling of satisfaction. One version is available for the father and another for the mother. Respondents rate their parenting competence on a six-point Likert-type scale ranging from "strongly agree" (1) to "strongly disagree" (6). The score can vary from 7 to 42, with a score of 7 to 13 indicating a very low sense of efficacy and a score of 38 to 42 indicating a very high sense of efficacy on the continuum. Higher scores mean thus a better outcome.
Time frame: Month 6
The PSOC questionnaire is composed of 17 statements that measure the feeling of competence in the exercise of the parental role. It has two subscales: seven statements concern the feeling of efficacy and ten others, the feeling of satisfaction. One version is available for the father and another for the mother. Respondents rate their parenting competence on a six-point Likert-type scale ranging from "strongly agree" (1) to "strongly disagree" (6). The score can vary from 7 to 42, with a score of 7 to 13 indicating a very low sense of efficacy and a score of 38 to 42 indicating a very high sense of efficacy on the continuum. Higher scores mean thus a better outcome.
Time frame: Month 12
The PSOC questionnaire is composed of 17 statements that measure the feeling of competence in the exercise of the parental role. It has two subscales: seven statements concern the feeling of efficacy and ten others, the feeling of satisfaction. One version is available for the father and another for the mother. Respondents rate their parenting competence on a six-point Likert-type scale ranging from "strongly agree" (1) to "strongly disagree" (6). The score can vary from 7 to 42, with a score of 7 to 13 indicating a very low sense of efficacy and a score of 38 to 42 indicating a very high sense of efficacy on the continuum. Higher scores mean thus a better outcome.
Time frame: Month 0
Child Adjustment and Parent Efficacy Scale (CAPES) is a parent-report questionnaire that measures child behavioural and emotional adjustment and parental efficacy. It consists of 30 items rated on a 4-point scale, ranging from not true of my child at all (0) to true of my child very much, or most of the time (3), where 20 items are two-part questions that assess both child behaviour and parent efficacy. Twenty-six items assess behaviour concerns (e.g., My child rudely answers back to me) and behavioural competencies (Behaviour Scale; e.g., My child follows rules and limits), and four items assess emotional adjustment (Emotional Maladjustment Scale; e.g., My child worries). Some items are reverse scored. Items are summed to yield a total intensity score (CAPES intensity scale: range of 0-90), which is made up of a behaviour score (range of 0-78) and an emotional maladjustment score (0-12) where high scores indicate higher levels of problems.
Time frame: Month 6
Child Adjustment and Parent Efficacy Scale (CAPES) is a parent-report questionnaire that measures child behavioural and emotional adjustment and parental efficacy. It consists of 30 items rated on a 4-point scale, ranging from not true of my child at all (0) to true of my child very much, or most of the time (3), where 20 items are two-part questions that assess both child behaviour and parent efficacy. Twenty-six items assess behaviour concerns (e.g., My child rudely answers back to me) and behavioural competencies (Behaviour Scale; e.g., My child follows rules and limits), and four items assess emotional adjustment (Emotional Maladjustment Scale; e.g., My child worries). Some items are reverse scored. Items are summed to yield a total intensity score (CAPES intensity scale: range of 0-90), which is made up of a behaviour score (range of 0-78) and an emotional maladjustment score (0-12) where high scores indicate higher levels of problems.
Time frame: Month 12
Child Adjustment and Parent Efficacy Scale (CAPES) is a parent-report questionnaire that measures child behavioural and emotional adjustment and parental efficacy. It consists of 30 items rated on a 4-point scale, ranging from not true of my child at all (0) to true of my child very much, or most of the time (3), where 20 items are two-part questions that assess both child behaviour and parent efficacy. Twenty-six items assess behaviour concerns (e.g., My child rudely answers back to me) and behavioural competencies (Behaviour Scale; e.g., My child follows rules and limits), and four items assess emotional adjustment (Emotional Maladjustment Scale; e.g., My child worries). Some items are reverse scored. Items are summed to yield a total intensity score (CAPES intensity scale: range of 0-90), which is made up of a behaviour score (range of 0-78) and an emotional maladjustment score (0-12) where high scores indicate higher levels of problems.
Time frame: Month 0
The Brief Coping Orientation to Problems Experienced (Brief-COPE) is a 28 item self-report questionnaire designed to measure effective and ineffective ways to cope with a stressful life event. "Coping" is defined broadly as an effort used to minimise distress associated with negative life experiences. The scale is often used in health-care settings to ascertain how patients are emotionally responding to a serious circumstance.
It is comprised of 14 scales, each of which assesses the degree to which a respondent utilizes a specific coping strategy. Respondents rate items on a 4-point Likert scale, ranging from 1 - "I haven't been doing this at all" to 4 - "I've been doing this a lot." Each of the 14 scales is comprised of 2 items; total scores on each scale range from 2 (minimum) to 8 (maximum). Higher scores indicate increased utilization of that specific coping strategy.
Time frame: Month 6
The Brief Coping Orientation to Problems Experienced (Brief-COPE) is a 28 item self-report questionnaire designed to measure effective and ineffective ways to cope with a stressful life event. "Coping" is defined broadly as an effort used to minimise distress associated with negative life experiences. The scale is often used in health-care settings to ascertain how patients are emotionally responding to a serious circumstance.
It is comprised of 14 scales, each of which assesses the degree to which a respondent utilizes a specific coping strategy. Respondents rate items on a 4-point Likert scale, ranging from 1 - "I haven't been doing this at all" to 4 - "I've been doing this a lot." Each of the 14 scales is comprised of 2 items; total scores on each scale range from 2 (minimum) to 8 (maximum). Higher scores indicate increased utilization of that specific coping strategy.
Time frame: Month 12
The Brief Coping Orientation to Problems Experienced (Brief-COPE) is a 28 item self-report questionnaire designed to measure effective and ineffective ways to cope with a stressful life event. "Coping" is defined broadly as an effort used to minimise distress associated with negative life experiences. The scale is often used in health-care settings to ascertain how patients are emotionally responding to a serious circumstance.
It is comprised of 14 scales, each of which assesses the degree to which a respondent utilizes a specific coping strategy. Respondents rate items on a 4-point Likert scale, ranging from 1 - "I haven't been doing this at all" to 4 - "I've been doing this a lot." Each of the 14 scales is comprised of 2 items; total scores on each scale range from 2 (minimum) to 8 (maximum). Higher scores indicate increased utilization of that specific coping strategy.
Contact information is provided by the study sponsor or research team.
Centre Hospitalier Universitaire Vaudois
Other
Impact of an E-Learning Parental Coaching for Parents of Young Children With Autism Spectrum Disorder
Acronym: ECOACH
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