Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-25 @ 8:18 PM
Study NCT ID:
NCT05018169
Status:
COMPLETED
Last Update Posted:
2023-11-18
First Post:
2021-08-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Behavioral Activation for Treatment of Depression in Adolescents With Autism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D001321', 'term': 'Autistic Disorder'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}, {'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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-15', 'studyFirstSubmitDate': '2021-08-03', 'studyFirstSubmitQcDate': '2021-08-18', 'lastUpdatePostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Treatment Fidelity Checklists', 'timeFrame': 'Within 3 months of treatment completion', 'description': 'Treatment Fidelity Checklists will be completed by trained research assistants not involved in the implementation of the intervention.'}, {'measure': 'Acceptability/Satisfaction Surveys and Interviews, Self Report', 'timeFrame': 'Post-treatment (i.e., within one week of finishing 12-week treatment)'}, {'measure': 'Acceptability/Satisfaction Surveys and Interviews, Parent Report', 'timeFrame': 'Post-treatment (i.e., within one week of finishing 12-week treatment)'}], 'primaryOutcomes': [{'measure': "Children's Depression Inventory, Second Edition, Parent Report", 'timeFrame': 'Change from pre-treatment to post-treatment (i.e., within one week of finishing 12-week treatment) and one-month following treatment'}, {'measure': "Children's Depression Inventory, Second Edition, Self Report", 'timeFrame': 'Change from pre-treatment to post-treatment (i.e., within one week of finishing 12-week treatment) and one-month following treatment'}, {'measure': "Children's Depression Rating Scale, Revised", 'timeFrame': 'Change from pre-treatment to post-treatment (i.e., within one week of finishing 12-week treatment) and one-month following treatment'}], 'secondaryOutcomes': [{'measure': "Spence Children's Anxiety Scale, Self Report", 'timeFrame': 'Change from pre-treatment to post-treatment (i.e., within one week of finishing 12-week treatment) and one-month following treatment'}, {'measure': "Spence Children's Anxiety Scale, Parent Report", 'timeFrame': 'Change from pre-treatment to post-treatment (i.e., within one week of finishing 12-week treatment) and one-month following treatment'}, {'measure': 'Social Skills Improvement System, Parent Report', 'timeFrame': 'Change from pre-treatment to post-treatment (i.e., within one week of finishing 12-week treatment) and one-month following treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Depression', 'Autism']}, 'descriptionModule': {'briefSummary': 'In this study, the investigators will examine the feasibility, acceptability, and preliminary efficacy of a novel, behavior-based approach for treatment of depression symptoms in adolescents with autism spectrum disorder or ASD (i.e., Behavioral Activation for Adolescents with ASD, BA-A).', 'detailedDescription': 'In this study, the investigators will examine the feasibility, acceptability, and preliminary efficacy of a novel, behavior-based approach for treatment of depression symptoms in adolescents with ASD (i.e., Behavioral Activation for Adolescents with ASD, BA-A). BA-A is a 12-session manualized treatment that utilizes established behavioral activation strategies and incorporates common mental health treatment adaptations for young people with ASD. For this project, the investigators will pilot BA-A with 23 adolescents (12-17 years of age) with ASD and clinically significant depression symptoms. To investigate BA-A feasibility, the investigators will examine treatment session attendance and therapist treatment fidelity. To investigate BA-A acceptability, the investigators will utilize a mixed methods approach, inclusive of surveys and qualitative interviews, to inform BA-A protocol refinement. To investigate BA-A preliminary efficacy, the investigators will examine depression symptoms, as well as secondary outcome measures, at pre-treatment, post-treatment, and one-month follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Previous diagnosis of ASD by a qualified health care provider\n* Children's Depression Inventory, Second Edition (CDI2) parent-report and/or self-report T- score ≥ 65\n* Wechsler Abbreviated Scale of Intelligence, Second Edition (WASI-II) Full Scale IQ, Two-Subtest Form (FSIQ-2) ≥ 85\n* Participation of a parent or legal guardian living in the same home who can read and write in English at or above the fifth grade level\n* Teens must have been on a stable dose of medications for mood, anxiety, or behavior for at least three months prior to enrollment and have no planned medication changes during study period\n* Not actively participating in another psychotherapy during study period\n\nExclusion Criteria:\n\n* High suicide risk\n* Physical aggression\n* Psychotic and/or manic symptoms"}, 'identificationModule': {'nctId': 'NCT05018169', 'acronym': 'BA-A', 'briefTitle': 'Behavioral Activation for Treatment of Depression in Adolescents With Autism', 'organization': {'class': 'OTHER', 'fullName': 'University of Virginia'}, 'officialTitle': 'Behavioral Activation for Treatment of Depression in Adolescents With Autism Spectrum Disorder: A Pilot Study', 'orgStudyIdInfo': {'id': 'HSR200385'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BA-A', 'description': 'Teens will participate in BA-A. BA-A is a 12-session manualized treatment that utilizes established BA strategies and incorporates common mental health treatment adaptations for young people with ASD.', 'interventionNames': ['Behavioral: BA-A']}], 'interventions': [{'name': 'BA-A', 'type': 'BEHAVIORAL', 'description': 'Session 1 focuses on the treatment rationale, structure, and expectations, and includes psychoeducation on depression. Session 2 focuses on working with parent(s) to help them support their teen through treatment. Session 3 focuses on the (situation)/behavior/feeling cycle and how teens individuals can get trapped in a cycle of depression and inactivity. Session 4 focuses on the assessment of values and choosing preferred activities to target. Session 5 focuses on teaching skills for in-person and electronic communication. Session 6 focuses on identifying barriers to treatment success. Session 7 focuses on teaching teens to handle disagreements. Session 8 focuses on the utilization of adaptive coping skills. Sessions 9-11 are meant to be used flexibly and should include review of any challenging concepts. Session 12 is the termination session and focuses on maintaining treatment gains. Between every session, teens will track their activity for homework.', 'armGroupLabels': ['BA-A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22903', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Virginia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Novartis U.S. Foundation Professor of Education', 'investigatorFullName': 'Micah Mazurek', 'investigatorAffiliation': 'University of Virginia'}}}}