Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-29 @ 3:33 AM
Study NCT ID:
NCT06030167
Status:
COMPLETED
Last Update Posted:
2023-09-08
First Post:
2023-07-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Insecure Attachment and Psychosocial Functioning in Autistic Adults Are Mediated by Depression and Paranoid Ideation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}, {'id': 'D001321', 'term': 'Autistic Disorder'}], 'ancestors': [{'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000083623', 'term': 'Psychosocial Functioning'}], 'ancestors': [{'id': 'D066233', 'term': 'Psychology, Developmental'}, {'id': 'D011584', 'term': 'Psychology'}, {'id': 'D001525', 'term': 'Behavioral Sciences'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D006304', 'term': 'Health Status'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 83}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-06', 'studyFirstSubmitDate': '2023-07-26', 'studyFirstSubmitQcDate': '2023-09-06', 'lastUpdatePostDateStruct': {'date': '2023-09-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Experiences in Close Relationships - Revised questionnaire (ECR-r)', 'timeFrame': '15 minutes', 'description': "Measuring self-rated levels of insecure attachment in 83 adults with autism spectrum disorder. Welch's two sample t-test was used to compare the ECR-r data between the participants and (non-)clinical controls drawn from the manuals of the used measure.\n\nThe ECR-R is a 36-item measure designed to assess individual differences with respect to attachment-related anxiety (i.e., the extent to which people are insecure versus secure about the availability and responsiveness of romantic partners; items 1 to 18) and attachment-related avoidance (i.e., the extent to which people are uncomfortable being close to others versus secure depending on others; items 19 to 36). The items are scored on a 7-point scale, with higher scores (\\>= 4) indicating more insecure attachment. A mean score (ranging from 0 to 7) is calculated for both attachment styles."}, {'measure': 'World Health Organisation Disability Assessment Schedule 2.0 (WHODAS 2.0)', 'timeFrame': '15 minutes', 'description': "Measuring self-rated levels of psycho-social functioning in 83 autistic adults. Welch's two sample t-test was used to compare the WHODAS 2.0 data between the participants and (non-)clinical controls drawn from the manuals of the used measure.\n\nWHODAS 2.0 is a generic assessment self-report for health and disability in adults, consisting of 36 items on a 5-point scale (none, mild, moderate, severe, and extreme) covering six domains: cognitions, mobility, self-care, interaction, life activities, and participation in society. WHODAS 2.0 asks the individual to rate how much difficulty they have had in specific areas of functioning during the past 30 days. WHODAS 2.0 produces standardized disability levels and profiles by summing six domain scores and converting the summary score into a metric range from 0 (= no disability) to 100 (= full disability)."}], 'secondaryOutcomes': [{'measure': 'Beck Depression Inventory-Second Edition-Dutch version-Revised (BDI-2-NL-R)', 'timeFrame': '10 minutes', 'description': "Measuring self-rated levels of depression in 83 autistic adults. Welch's two sample t-test was used to compare the BDI-2-NL-R data between the participants and (non-)clinical controls drawn from the manuals of the used measure.\n\nThe BDI-2-NL-R is a 21-item self report assessing the presence and severity of depressive symptoms, according to the Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV; American Psychiatric Association, 1994). The BDI-2-NL-R is also compatible with DSM-5 depressive disorder (APA, 2013; 2022). The items are scored on a 4-point scale with a total score ranging from 0 to 63 indicating minimal (0-13), mild (14-19), moderate (20-28), or severe (29-63) depression."}, {'measure': 'Green Paranoid Thought Scales (GPTS)', 'timeFrame': '15 minutes', 'description': "Measuring self-rated levels of paranodi thoughts in 83 autistic adults. Welch's two sample t-test was used to compare the GPTS data between the participants and (non-)clinical controls drawn from the manuals of the used measure.\n\nThe GPTS is a 32-item self-report assessing 16 ideas of persecution and 16 ideas of social reference on a 5-point scale, with a total score ranging from 32 to 160, with higher scores indicating higher levels of paranoid ideation."}, {'measure': 'FEEL-E Questionnaire for Emotion Regulation in Adults (FEEL-E)', 'timeFrame': '20 minutes', 'description': "Measuring self-rated levels of emotion regulation in 83 autistic adults. Welch's two sample t-test was used to compare the GPTS data between the participants and (non-)clinical controls drawn from the manuals of the used measure.\n\nThe FEEL-E is a 72-item self-report questionnaire assessing emotion regulation strategies, consisting of six adaptive (problem-oriented action, acceptance, cognitive problem-solving, reappraisal, evoking positive feelings, forgetting) and six maladaptive (withdrawal, self-blame, resignation, rumination, negative thinking, other-blame) strategies. The items are scored on a 5-point scale with a total score ranging from 36 to 180 for each strategy (T-score \\< 40: below average use of strategy; T-score 40-60: average use of strategy; T-score \\> 60: above average use of strategy)."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Autism', 'Attachment', 'Psychosocial functioning', 'Adults'], 'conditions': ['Autism Spectrum Disorder']}, 'descriptionModule': {'briefSummary': 'The present study examines if depressive symptoms, paranoid ideation, and emotion regulation strategies mediate the relationship between attachment and psychosocial functioning in autistic adults.', 'detailedDescription': 'The present study examines if depressive symptoms, paranoid ideation, and emotion regulation strategies mediate the relationship between attachment and psychosocial functioning in autistic adults. Within a cross-sectional design, we used mediation analysis to clarify the roles of co-occurring mental conditions as depressive symptoms, paranoid ideation, and (mal)adaptive emotion regulation strategies in mediating the pathway from insecure attachment to psychosocial functioning in autistic adults. Questionaires about attachment, psychosocial functioning, depressive symptoms, paranoid ideation, and emotion regulation were administered to 83 autistic adults (50 males, 33 females).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* a primary clinical diagnosis of DSM-5 ASD (APA, 2013)\n* age ≥ 18 years\n* at least eight years of education.\n\nExclusion Criteria:\n\n* intellectual disability (IQ ≤ 80)\n* presence of current suicidal ideation.'}, 'identificationModule': {'nctId': 'NCT06030167', 'briefTitle': 'Insecure Attachment and Psychosocial Functioning in Autistic Adults Are Mediated by Depression and Paranoid Ideation', 'organization': {'class': 'OTHER', 'fullName': 'Parnassia Groep'}, 'officialTitle': 'Insecure Attachment and Psychosocial Functioning in Autistic Adults Are Mediated by Depression and Paranoid Ideation', 'orgStudyIdInfo': {'id': 'CWO-27-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Assessment of attachment and psychosocial functioning in adults with ASD', 'description': 'Questionaires about attachment, psychosocial functioning, depressive symptoms, paranoid ideation, and emotion regulation were administered to 83 autistic adults (50 males, 33 females).', 'interventionNames': ['Behavioral: Insecure attachment and psychosocial functioning in autistic adults']}], 'interventions': [{'name': 'Insecure attachment and psychosocial functioning in autistic adults', 'type': 'BEHAVIORAL', 'description': 'Questionaires about attachment, psychosocial functioning, depressive symptoms, paranoid ideation, and emotion regulation were administered to 83 autistic adults (50 males, 33 females).', 'armGroupLabels': ['Assessment of attachment and psychosocial functioning in adults with ASD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3083AK', 'city': 'Rotterdam', 'state': 'South Holland', 'country': 'Netherlands', 'facility': 'Parnassia Antes', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}], 'overallOfficials': [{'name': 'Richard Vuijk, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Parnassia Antes'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Parnassia Groep', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Richard Vuijk', 'investigatorAffiliation': 'Parnassia Groep'}}}}