- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07360223
Internalized Symptoms in Adolescents With Autism Spectrum Disorder (ASD) and Typically Developing Adolescents : Gaining Insight Into Coping Strategies and the Psychological Processes Involved
Introduction: Adolescents with autism spectrum disorder (ASD) have more mental health problems than typically developping adolescents (without ASD). Coping strategies are a key concern for adolescents with ASD in managing depressive and anxiety symptoms. Currently, few studies have examined the coping strategies used by adolescents with ASD. The methodological considerations underscore the need for an assessment method tailored to adolescents with ASD. Finally, although current data are still limited, the results suggest that there may be differences between the coping strategies used by adolescents with ASD and typically developing adolescents, thus calling for more in-depth comparative research.
Objectives: This study aims to validate a coping strategies assessment method adapted for adolescents with ASD (1) and to examine coping strategies associated with internalizing symptoms (2)
Population: 252 participants: 84 adolescents with ASD (1), 84 adolescents with autistic traits but no clinical diagnosis of ASD (2), and 84 typically developing adolescents (3). The age range is 12-17 years.
Study design: The study is divided into two parts: a cross-sectional part (T) and a longitudinal part (L).
- The cross-sectional part will include three meetings spread over a period of approximately three months (approximately one meeting per month).
- The longitudinal part will consist of a meeting scheduled one year after the last meeting of the cross-sectional part.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Héloïse HL Louvegny, PhD Student
- Phone Number: 0471 55 84 10 010 47 80 60
- Email: heloise.louvegny@uclouvain.be
Study Contact Backup
- Name: Stéphanie SM Mazzone, Postdoctoral
- Phone Number: 02 764 20 34
- Email: stephanie.mazzone@saintluc.uclouvain.be
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 12-17 years
- speak french fluently
Exclusion Criteria:
- Intellectual disability
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Adolescents with autistic traits without a clinical diagnosis of ASD
Adolescents with autistic traits without a clinical diagnosis of ASD: T score between 66-75 on the SRS-2
|
Participants will complete questionnaires and take part in a semi-structured interview
|
|
Adolescents diagnosed with ASD
ASD diagnosis made by a specialist physician
|
Participants will complete questionnaires and take part in a semi-structured interview
|
|
Adolescents
Typically developing adolescents (without ASD)
|
Participants will complete questionnaires and take part in a semi-structured interview
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Coping strategies
Time Frame: Throughout the entire study, approximately during 5 years
|
Measure by questionnaire and semi-structured interviews.
Questionnaire : Coping Strategies Inventory (CSI) The questionnaire is designed to identify coping strategy profiles.
It includes 8 sub-strategies (Problem solving, Cognitive restructuring, Express Emotions, Social Support, Problem avoidance, Wishful thinking, Self-Criticism, Social Withdrawal) and does not have strict minimum or maximum scores.
Instead, it provides an overview of the relative use of each coping strategy
|
Throughout the entire study, approximately during 5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anxious, depressive and somatic symptoms
Time Frame: Throughout the entire study, approximately during 5 years
|
Measure by questionnaire Questionnaire : Revised Children's Anxiety and Depression Scale (RCADS) T-score < 65 → Non-clinical range. Symptoms are minimal or within the typical range compared to the normative population. No clinical concern is indicated T-score ≥ 65 → Borderline/clinically elevated Symptoms are higher than average and may indicate potential anxiety or depression issues. T-score ≥ 70 → Clinically significant range Symptoms are substantially elevated compared to peers. There is a high likelihood of clinically meaningful anxiety or depression |
Throughout the entire study, approximately during 5 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perfectionnism
Time Frame: Throughout the entire study, approximately during 5 years
|
Measure by questionnaire
|
Throughout the entire study, approximately during 5 years
|
|
Self-perception
Time Frame: Throughout the entire study, approximately during 5 years
|
Measure by questionnaire
|
Throughout the entire study, approximately during 5 years
|
|
Perceived social support
Time Frame: Throughout the entire study, approximately during 5 years
|
Measure by questionnaire
|
Throughout the entire study, approximately during 5 years
|
|
Alexithymia
Time Frame: Throughout the entire study, approximately during 5 years
|
Measure by questionnaire
|
Throughout the entire study, approximately during 5 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nathalie NNG Nader-Grosbois, Professor, Université Catholique de Louvain (UCLouvain)
Publications and helpful links
General Publications
- Rieffe C, Oosterveld P, Terwogt MM, Mootz S, van Leeuwen E, Stockmann L. Emotion regulation and internalizing symptoms in children with autism spectrum disorders. Autism. 2011 Nov;15(6):655-70. doi: 10.1177/1362361310366571. Epub 2011 Jul 6.
- Rieffe C, De Bruine M, De Rooij M, Stockmann L. Approach and avoidant emotion regulation prevent depressive symptoms in children with an Autism Spectrum Disorder. Int J Dev Neurosci. 2014 Dec;39:37-43. doi: 10.1016/j.ijdevneu.2014.06.003. Epub 2014 Jun 19.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Neurodevelopmental Disorders
- Child Development Disorders, Pervasive
- Autism Spectrum Disorder
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Data Collection
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Interviews as Topic
- Surveys and Questionnaires
Other Study ID Numbers
- TSA coping
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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