Trial · NCT07895758
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To assess the intensity of the seasonality of depressive symptoms in adolescents receiving care for child psychiatric reasons at the Rouen University Hospital | 1 day | The intensity of the seasonality of depressive symptoms will be measured using the continuous Global Seasonality Score (GSS) from the SPAQ. The GSS is the sum of six items related to seasonal variation (sleep, social activity, mood, weight, appetite, and energy), each rated from 0 to 4, resulting in a total score ranging from 0 to 24. A high score indicates greater reported seasonal variations |
| Secondary | Determine the proportion of adolescents with a profile consistent with seasonal affective disorder, based on the Global Seasonality Score (GSS) from the SPAQ. | 1 day | Proportion of adolescents whose responses to the SPAQ questionnaire correspond to a profile consistent with seasonal affective disorder (SAD) or a subsyndromal profile (S-SAD). The classification is based on two complementary elements: * The GSS: the seasonality score, ranging from 0 to 24. * Perceived impairment: the extent to which seasonal variations affect the adolescent's life, assessed via a specific item in the questionnaire. The classification will be based on the following profiles : 1. Profile consistent with SAD (Seasonal Affective Disorder) \- GSS ≥ 11 and at least moderate impairment. The adolescent reports significant seasonal variations, accompanied by at least a moderate impact. 2. Profile compatible with S-SAD (Subsyndromal Seasonal Affective Disorder) Two scenarios are possible: * A GSS (Global Seasonality Score) between 8 and 10, accompanied by at least mild impairment. * A GSS ≥ 11, but without significant impairment. Seasonal variations are present, but their |
| Secondary | Describe the clinical and sociodemographic characteristics associated with seasonal variation in depressive symptoms (age, sex, psychiatric history, context of hospitalization, family psychiatric history (especially disorders)). | 1 day | Determination of factors associated with seasonality (age, sex, medical history, reason for hospitalization, and family and personal psychiatric history). |
| Secondary | Describe the clinical and sociodemographic characteristics associated with seasonal variation in depressive symptoms (age). | 1 day | Determination of factors associated with seasonality (age) |
| Secondary | Describe the clinical and sociodemographic characteristics associated with seasonal variation in depressive symptoms (sex). | 1 day | Determination of factors associated with seasonality (sex). |
| Secondary | Describe the clinical and sociodemographic characteristics associated with seasonal variation in depressive symptoms (psychiatric history). | 1 day | Determination of factors associated with seasonality (psychiatric history). |
| Secondary | Describe the clinical and sociodemographic characteristics associated with seasonal variation in depressive symptoms (context of hospitalization). | 1 day | Determination of factors associated with seasonality (reason for hospitalization). |
| Secondary | Describe the clinical and sociodemographic characteristics associated with seasonal variation in depressive symptoms (medical history). | 1 day | Determination of factors associated with seasonality (medical history). |
| Secondary | To evaluate the feasibility of using the SPAQ in an adolescent population hospitalized in a pediatric setting. | 1 day | The completion rate for the SPAQ questionnaire is an important indicator of the feasibility of its use among adolescents hospitalized in pediatric settings. It makes it possible to measure the proportion of questionnaires that are filled out-ideally, with a sufficient level of completeness to be usable. The completion rate for the SPAQ questionnaire is number of completed questionnaires out of the number of questionnaires for which administration was undertaken. The feasibility of using the SPAQ will be assessed, in particular, by the questionnaire completion rate, defined as the proportion of fully completed and usable questionnaires out of the total number of questionnaires that were initiated. |
| Secondary | To evaluate the relevance of using the SPAQ in an adolescent population hospitalized in a pediatric setting (Taken Time). | 1 day | The time taken to complete the questionnaire will make it possible to assess its ease of use. The administration time is determined by subtracting the start time from the end time to obtain the duration, in minutes, taken to complete the questionnaire. |
| Secondary | To evaluate the relevance of using the SPAQ in an adolescent population hospitalized in a pediatric setting (Feedback from adolescents). | 1 day | The aim is to assess the understanding of the questions, the difficulties encountered, and the feelings experienced in relation to the questionnaire. The acceptability of the questionnaire will be assessed by collecting brief feedback from the adolescents after they have completed it. This will focus, in particular, on their understanding of the questions, the ease of filling out the questionnaire, its perceived length, and any difficulties encountered. The responses will be analyzed descriptively, using counts and proportions for the closed-ended questions. |
| Secondary | Comparing the SPAQ score with the clinical assessment of seasonality | 1 day | This assessment is part of the standard child and adolescent psychiatric evaluation and requires no additional procedures; the clinician will conduct it without knowledge of the SPAQ score. The adolescent completes the questionnaire. The investigator calculates their GSS score, which measures the magnitude of the reported seasonal variations. A child and adolescent psychiatrist explores the seasonal nature of depressive episodes using a semi-structured interview based on DSM-5 criteria. Researchers compare the SPAQ result with the conclusion of the clinical assessment to examine the level of agreement between the two. The DSM-5 is a reference manual used by mental health professionals to describe, classify, and diagnose psychiatric disorders according to defined criteria. The DSM-5 serves as a reference for exploring the seasonal nature of depressive episodes. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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