Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-01-06 @ 3:20 AM
Study NCT ID:
NCT06633458
Status:
RECRUITING
Last Update Posted:
2024-10-09
First Post:
2024-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adolescent Psychiatry Inpatients: Self-reported Parent-adolescent Communication Quality and Treatment Outcome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D000092862', 'term': 'Psychological Well-Being'}, {'id': 'D003142', 'term': 'Communication'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2026-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-08', 'studyFirstSubmitDate': '2024-07-30', 'studyFirstSubmitQcDate': '2024-10-08', 'lastUpdatePostDateStruct': {'date': '2024-10-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in self-rated relevant symptoms according to the discharge diagnosis (general mental health)', 'timeFrame': 'From baseline to 6 months after admission (T3)', 'description': 'General mental health symptoms will be assessed with the YSR (Youth Self-Report). If a condition other than F32-33 or F40-41 is the primary diagnosis, the YSR total scale will be used. The YSR consists of 112 items, rated on a three-step scale. Higher values indicate higher symptom burden.'}, {'measure': 'Change in self-rated relevant symptoms according to the discharge diagnosis (depression symptoms)', 'timeFrame': 'From baseline to 6 months after admission (T3)', 'description': 'Depression symptoms will be assessed with the DISYPS-DES (Diagnostik-System für Psychische Störungen - Depressive Störungen). If the primary diagnosis is depression (F32-F33), DISYPS-DES will be used. The DISYPS-DES consists of consist of 29 items, rated on a four-step scale. Higher values indicate higher symptom burden.'}, {'measure': 'Change in self-rated relevant symptoms according to the discharge diagnosis (anxiety symptoms)', 'timeFrame': 'From baseline to 6 months after admission (T3)', 'description': 'Anxiety symptoms will be assessed with the DISYPS-ANG (Diagnostik-System für Psychische Störungen - Angststörungen). If the primary diagnosis is anxiety (F40-F41), DISYPS-ANG will be used for the primary outcome. The DISYPS-ANG consists of 44 items, rated on a four-step scale. Higher values indicate higher symptom burden.'}, {'measure': 'Discussion of external placement (rated by clinician)', 'timeFrame': 'From baseline to 6 months after admission (T3)', 'description': 'The responsible clinician rates whether an external placement (outside the family) of the adolescent was discussed in the context of psychiatric treatment (yes/no). It has to be considered as discussed (\\"yes\\") if either the adolescent, one parent or more or the treatment team articulate a wish/recommendation regarding external placement during the period of treatment toward any other party.'}], 'secondaryOutcomes': [{'measure': 'Change in self-rated parent-adolescent communication quality', 'timeFrame': 'From baseline to 6 months after admission (T3)', 'description': 'PACS (Parent-Adolescent Communication Scale) questionnaire. The PACS consists of 20 items rated on a five-step scale and ranges from 20-100 with better values indicating higher communication quality.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mental health', 'adolescence', 'communication'], 'conditions': ['Mental Disorder in Adolescence', 'Depression in Adolescence', 'Anxiety']}, 'descriptionModule': {'briefSummary': 'The quality of parent-adolescent communication has been found to be associated with adolescent mental health. However, little is known about the association of parent-adolescent communication and adolescent mental health in the context of psychiatry inpatient treatment.\n\nThis study aims to find out whether self-reported parent-adolescent communication quality at the time of admission to psychiatry predicts the treatment outcome in terms of symptom reduction 6 months later in an adolescent inpatient sample. It also aims to track changes in adolescent self-reported communication quality in the course of inpatient treatment and afterwards (2, 4 and 6 months after admission) to see whether improvement predicts treatment outcome, with treatment outcome being defined as symptom reduction to baseline. As a secondary endpoint, it will be assessed whether a placement of the adolescent outside the family was considered during treatment and whether self-reported communication quality at the time of admission predicts the consideration of placement outside the family.', 'detailedDescription': "The main hypotheses of the study are:\n\n1a Higher quality of self-reported parent-adolescent communication at baseline is positively associated with higher symptom reduction from baseline (psychiatry admission, t0) to 6 months after admission (t3).\n\n1. b Higher improvement of parent-adolescent communication from t0 to t3 is positively associated with higher symptom reduction from t0 to t3.\n2. Higher quality of self-reported parent-adolescent communication at baseline is negatively associated with consideration of the adolescent's placement outside the family during treatment.\n\nThe hypotheses 1a and 1b will be assessed with a linear regression model, hypothesis 2 will be assessed with a logistic regression model.\n\nCovariates that will be taken into consideration are symptom severity at baseline, socioeconomic status of the family, adolescent gender, age, and comorbidity. Sensitivity analyses will be calculated for inpatient treatment duration and outpatient treatment duration after discharge from the hospital.\n\nSymptom severity as the primary outcome is assessed with three measures: YSR (Youth Self-Report), DISYPS-ANG (Diagnostik-System für Psychische Störungen - Angststörungen) and DISYPS-DES Diagnostik-System für Psychische Störungen - Depressive Störungen). The relevant scale will be chosen according to the primary clinical diagnosis: If the primary diagnosis is anxiety (F40-F41), DISYPS-ANG will be used for the primary outcome. If the primary diagnosis is depression (F32-F33), DISYPS-DES will be used. If any other condition is the primary diagnosis, the YSR total scale will be used. Raw values of the DISYPS and the YSR will be transformed into z-values."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '14 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adolescents aged 14;1 to 17;12 years with a diagnosis of a mental disorder requiring inpatient treatment at a psychiatric site.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Admission to inpatient care unit of the adolescent psychiatry at the University Medical Center Hamburg-Eppendorf.\n\nExclusion Criteria:\n\n* Severe symptom burden at admission\n* Lack of knowledge of the German language.'}, 'identificationModule': {'nctId': 'NCT06633458', 'briefTitle': 'Adolescent Psychiatry Inpatients: Self-reported Parent-adolescent Communication Quality and Treatment Outcome', 'organization': {'class': 'OTHER', 'fullName': 'Universitätsklinikum Hamburg-Eppendorf'}, 'officialTitle': 'Adolescent Psychiatry Inpatients: Self-reported Parent-adolescent Communication Quality As a Predictor of Treatment Outcome', 'orgStudyIdInfo': {'id': 'JuStCom'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study group (observation only)', 'description': 'Adolescent inpatients at the child and adolescent psychiatry, age 14-17 years.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20246', 'city': 'Hamburg', 'state': 'Hamburg', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'University Medical Center Hamburg-Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}], 'centralContacts': [{'name': 'Holger Zapf, Dr', 'role': 'CONTACT', 'email': 'h.zapf@uke.de', 'phone': '+49 176 8441 2529'}], 'overallOfficials': [{'name': 'Holger Zapf, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitätsklinikum Hamburg-Eppendorf'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitätsklinikum Hamburg-Eppendorf', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}