Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-31 @ 1:26 AM
Study NCT ID:
NCT07416903
Status:
COMPLETED
Last Update Posted:
2026-02-18
First Post:
2026-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NT-Based Group Psychoeducation for Parents of Autistic Preschoolers in Türkiye
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}], 'ancestors': [{'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-12-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2025-01-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-13', 'studyFirstSubmitDate': '2026-02-09', 'studyFirstSubmitQcDate': '2026-02-13', 'lastUpdatePostDateStruct': {'date': '2026-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Parental Self-Efficacy Score at Follow-up', 'timeFrame': 'Approximately 9 months after post-test', 'description': 'Parental self-efficacy assessed at follow-up to examine maintenance of post-test gains, using the Turkish Early Intervention Parenting Self-Efficacy Scale (13 items; total score range 13-91; higher scores indicate greater parental self-efficacy \\[better outcome\\]). If follow-up was collected only for the intervention arm, this outcome applies to the intervention arm only.'}], 'primaryOutcomes': [{'measure': 'Parental Self-Efficacy Score (Turkish Early Intervention Parenting Self-Efficacy Scale)', 'timeFrame': 'Baseline and 10 weeks (post-test)', 'description': 'Change in parental self-efficacy from baseline to post-test, assessed using the Turkish Early Intervention Parenting Self-Efficacy Scale (13 items; total score range 13-91; 7-point Likert responses; higher scores indicate greater parental self-efficacy \\[better outcome\\]). The scale includes the Accessing Services and Supports and Parenting Strategies subscales.'}], 'secondaryOutcomes': [{'measure': 'Retention Rate', 'timeFrame': 'Baseline to post-test (end of week 10)', 'description': 'Baseline and 10 weeks (post-test)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Naturalistic Teaching', 'Psychoeducation', 'Parent-mediated intervention', 'Caregivers', 'Preschool', 'Early intervention', 'Parent training', 'Routine-based strategies', 'Randomized trial'], 'conditions': ['Autism Spectrum Disorder', 'Parenting Self-efficacy']}, 'descriptionModule': {'briefSummary': 'This pilot randomized study examines the feasibility and preliminary effects of a Naturalistic Teaching (NT)-based group psychoeducation program for parents of autistic preschool children in Türkiye. After providing consent, parents are randomized to one of three conditions: (1) a 10-week NT-based group psychoeducation program delivered weekly (90 minutes per session), (2) a single-session general parenting seminar that does not include autism-specific content (attention control), or (3) a wait-list control group that receives access to intervention materials after the post-test. The primary outcome is parental self-efficacy, assessed using parent-report questionnaires. Outcomes are measured at baseline and post-test, and a later follow-up assessment is used to evaluate whether improvements are maintained. The study also tracks feasibility indicators such as retention and session attendance.', 'detailedDescription': "The intervention is a Naturalistic Teaching (NT)-based group psychoeducation program for parents of autistic preschool children. The program includes 10 weekly sessions (90 minutes each) focused on increasing parents' confidence and skills to use everyday routines to support their child, with emphasis on routine-embedded strategies and parent empowerment. The comparator conditions include an attention control (single-session general parenting seminar) and a wait-list control. The primary outcome is parental self-efficacy; secondary outcomes include feasibility indicators (retention and attendance) and maintenance assessed at follow-up on January 13, 2025."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:Inclusion Criteria:\n\n* Adult (18 years or older).\n* Primary caregiver (e.g., mother/father) of a preschool-aged child with autism spectrum disorder.\n* Able to attend the sessions (if assigned to the intervention/attention control) and complete study questionnaires.\n* Provides informed consent.\n\nExclusion Criteria:\n\n* Inability to provide informed consent.\n* Insufficient proficiency in Turkish to complete questionnaires and participate in sessions.'}, 'identificationModule': {'nctId': 'NCT07416903', 'briefTitle': 'NT-Based Group Psychoeducation for Parents of Autistic Preschoolers in Türkiye', 'organization': {'class': 'OTHER', 'fullName': 'Kocaeli University'}, 'officialTitle': 'A Naturalistic Teaching-Based Group Psychoeducation Program for Parents of Autistic Preschoolers in Türkiye: A Mixed-Methods Pilot Randomized Trial', 'orgStudyIdInfo': {'id': 'Approval No: 2023/06-18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NT-Based Group Psychoeducation', 'description': 'Participants receive a Naturalistic Teaching (NT)-based group psychoeducation program consisting of 10 weekly sessions (90 minutes each) for parents of autistic preschool children.', 'interventionNames': ['Behavioral: NT-Based Group Psychoeducation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Attention Control: General Parenting Seminar', 'description': 'Participants receive a single-session general parenting seminar (approximately 60 minutes) that does not include autism-specific content (attention control).', 'interventionNames': ['Behavioral: General Parenting Seminar (Attention Control)']}, {'type': 'NO_INTERVENTION', 'label': 'Wait-List Control', 'description': 'Participants receive no intervention during the study period and are offered access to intervention materials after the post-test assessment.'}], 'interventions': [{'name': 'NT-Based Group Psychoeducation', 'type': 'BEHAVIORAL', 'description': 'A Naturalistic Teaching (NT)-based group psychoeducation program delivered in 10 weekly sessions (90 minutes each) for parents of autistic preschool children, focusing on routine-embedded strategies and parent empowerment.', 'armGroupLabels': ['NT-Based Group Psychoeducation']}, {'name': 'General Parenting Seminar (Attention Control)', 'type': 'BEHAVIORAL', 'description': 'A single-session general parenting seminar (approximately 60 minutes) focusing on general parenting topics without autism-specific content.', 'armGroupLabels': ['Attention Control: General Parenting Seminar']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41001', 'city': 'Kocaeli', 'state': 'Izmit', 'country': 'Turkey (Türkiye)', 'facility': 'Kocaeli University, Faculty of Education', 'geoPoint': {'lat': 39.62497, 'lon': 27.51145}}], 'overallOfficials': [{'name': 'Türker Orkun Arslan, MA', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kocaeli University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Beginning 3 months after study completion and ending 5 years after study completion.', 'ipdSharing': 'YES', 'description': 'De-identified individual participant data (IPD) that underlie the results reported in the manuscript.', 'accessCriteria': 'IPD and supporting documents will be shared upon reasonable request to the corresponding author after publication. Requests will be reviewed for scientific merit and compliance with ethics approval and applicable regulations. Data will be provided in de-identified form only, to qualified researchers for non-commercial purposes, under a data use agreement, and via a secure file transfer method.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kocaeli University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc.Prof.', 'investigatorFullName': 'Osman Nejat Akfırat', 'investigatorAffiliation': 'Kocaeli University'}}}}