Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:01 AM
Study NCT ID:
NCT04922502
Status:
COMPLETED
Last Update Posted:
2025-03-04
First Post:
2021-05-25
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Parent-based Treatment for Youth With Anxiety and Obsessive-compulsive Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001010', 'term': 'Anxiety, Separation'}, {'id': 'D000098647', 'term': 'Generalized Anxiety Disorder'}, {'id': 'D016584', 'term': 'Panic Disorder'}, {'id': 'D009771', 'term': 'Obsessive-Compulsive Disorder'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001638', 'term': 'Bibliotherapy'}], 'ancestors': [{'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'eric.storch@bcm.edu', 'phone': '(713) 798-3579', 'title': 'Dr. Eric Storch', 'organization': 'Baylor College of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': "Participants were assessed up to 16 weeks. Non-responders to bibliotherapy had the option to participate in standard SPACE, and were possibly followed for an additional 8 weeks (for a total of 24 weeks). Adverse event data were collected for child participants only and were collected for the duration of a participant's involvement in the study.", 'description': 'The definition of an adverse event does not differ from that used on clinicaltrials.gov', 'eventGroups': [{'id': 'EG000', 'title': 'Standard SPACE', 'description': '12 one hour parent sessions over 12 weeks in which the therapist guides the parent to target anxious behaviors and support adaptive child behaviors.\n\nStandard SPACE: 12 one hour parent sessions over 12 weeks in which the therapist guides the parent to target anxious behaviors and support adaptive child behaviors.', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 0, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Bibliotherapy, Low Therapist Contact SPACE', 'description': '4 one hour parent sessions over 12 weeks in which the therapist supports the parent in understanding and implementing content reviewed in the book "Breaking Free of Child Anxiety and OCD".\n\nBibliotherapy, low therapist contact SPACE: 4 one hour parent sessions over 12 weeks in which the therapist supports the parent in understanding and implementing content reviewed in the book "Breaking Free of Child Anxiety and OCD".', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 0, 'seriousNumAtRisk': 35, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pediatric Anxiety Rating Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard SPACE', 'description': '12 one hour parent sessions over 12 weeks in which the therapist guides the parent to target anxious behaviors and support adaptive child behaviors.\n\nStandard SPACE: 12 one hour parent sessions over 12 weeks in which the therapist guides the parent to target anxious behaviors and support adaptive child behaviors.'}, {'id': 'OG001', 'title': 'Bibliotherapy, Low Therapist Contact SPACE', 'description': '4 one hour parent sessions over 12 weeks in which the therapist supports the parent in understanding and implementing content reviewed in the book "Breaking Free of Child Anxiety and OCD".\n\nBibliotherapy, low therapist contact SPACE: 4 one hour parent sessions over 12 weeks in which the therapist supports the parent in understanding and implementing content reviewed in the book "Breaking Free of Child Anxiety and OCD".'}], 'classes': [{'categories': [{'measurements': [{'value': '10.86', 'spread': '4.80', 'groupId': 'OG000'}, {'value': '10.96', 'spread': '6.08', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (before treatment), post-treatment assessment (on average 12 weeks), one month follow up; Baseline scores reported.', 'description': 'Clinician-rated child anxiety severity throughout the past week. Each item is scored on a 0 to 5 scale (higher scores correspond to greater severity), yielding a total between 0 and 35.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Three participants did not complete the standard SPACE intervention, and 4 participants did not complete the low-therapist contact SPACE intervention'}, {'type': 'SECONDARY', 'title': 'Anxiety Disorders Interview Schedule (ADIS-IV) With Clinical Severity Ratings', 'timeFrame': 'Up to 24 weeks', 'description': 'Clinician-rated diagnostic interview that includes current anxiety disorders, depression, obsessive-compulsive disorder, and related disorders. Each diagnostic category is coded as present or absent based on symptom criteria and clinical severity ratings (CSRs), which indicate the level of clinical interference. CSRs are scored on a 0-8 scale (0 = not at all; 8 = very, very much). CSRs of 4 or above indicate the clinical levels.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Clinical Global Impression-Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard SPACE', 'description': '12 one hour parent sessions over 12 weeks in which the therapist guides the parent to target anxious behaviors and support adaptive child behaviors.\n\nStandard SPACE: 12 one hour parent sessions over 12 weeks in which the therapist guides the parent to target anxious behaviors and support adaptive child behaviors.'}, {'id': 'OG001', 'title': 'Bibliotherapy, Low Therapist Contact SPACE', 'description': '4 one hour parent sessions over 12 weeks in which the therapist supports the parent in understanding and implementing content reviewed in the book "Breaking Free of Child Anxiety and OCD".\n\nBibliotherapy, low therapist contact SPACE: 4 one hour parent sessions over 12 weeks in which the therapist supports the parent in understanding and implementing content reviewed in the book "Breaking Free of Child Anxiety and OCD".'}], 'classes': [{'categories': [{'measurements': [{'value': '2.42', 'spread': '0.89', 'groupId': 'OG000'}, {'value': '2.52', 'spread': '0.93', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (before treatment), post-treatment assessment (on average 12 weeks), one month follow up; Baseline scores reported.', 'description': 'Clinician-rated child psychopathology severity rating. A single item is scored 0-6 (0= no illness; 6= extremely severe symptoms).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'three participants did not complete the standard SPACE intervention and 4 participants did not complete the low-therapist contact SPACE intervention. Data for baseline scores reported.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard SPACE', 'description': '12 one hour parent sessions over 12 weeks in which the therapist guides the parent to target anxious behaviors and support adaptive child behaviors.\n\nStandard SPACE: 12 one hour parent sessions over 12 weeks in which the therapist guides the parent to target anxious behaviors and support adaptive child behaviors.'}, {'id': 'FG001', 'title': 'Bibliotherapy, Low Therapist Contact SPACE', 'description': '4 one hour parent sessions over 12 weeks in which the therapist supports the parent in understanding and implementing content reviewed in the book "Breaking Free of Child Anxiety and OCD".\n\nBibliotherapy, low therapist contact SPACE: 4 one hour parent sessions over 12 weeks in which the therapist supports the parent in understanding and implementing content reviewed in the book "Breaking Free of Child Anxiety and OCD".'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'No cross-over between Bibliotherapy, Low Therapist Contact SPACE to Standard SPACE occurred.', 'achievements': [{'comment': 'Sample reflects parent-child dyads including 33 parents and 33 children.', 'groupId': 'FG000', 'numSubjects': '66'}, {'comment': 'Sample reflects parent-child dyads including 35 parents and 35 children.', 'groupId': 'FG001', 'numSubjects': '70'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Sample reflects parent-child dyads including 30 parents and 30 children.', 'groupId': 'FG000', 'numSubjects': '60'}, {'comment': 'Sample reflects parent-child dyads including 31 parents and 31 children.', 'groupId': 'FG001', 'numSubjects': '62'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '8'}]}]}], 'preAssignmentDetails': 'Enrollment numbers reflect both parent and child of the parent-child dyads.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard SPACE', 'description': '12 one hour parent sessions over 12 weeks in which the therapist guides the parent to target anxious behaviors and support adaptive child behaviors.\n\nStandard SPACE: 12 one hour parent sessions over 12 weeks in which the therapist guides the parent to target anxious behaviors and support adaptive child behaviors.'}, {'id': 'BG001', 'title': 'Bibliotherapy, Low Therapist Contact SPACE', 'description': '4 one hour parent sessions over 12 weeks in which the therapist supports the parent in understanding and implementing content reviewed in the book "Breaking Free of Child Anxiety and OCD".\n\nBibliotherapy, low therapist contact SPACE: 4 one hour parent sessions over 12 weeks in which the therapist supports the parent in understanding and implementing content reviewed in the book "Breaking Free of Child Anxiety and OCD".'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '10.2', 'spread': '2.6', 'groupId': 'BG000'}, {'value': '10.2', 'spread': '2.8', 'groupId': 'BG001'}, {'value': '10.2', 'spread': '2.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Clinical Global Impressions Scale-Severity', 'classes': [{'categories': [{'measurements': [{'value': '3.48', 'spread': '.67', 'groupId': 'BG000'}, {'value': '3.54', 'spread': '.82', 'groupId': 'BG001'}, {'value': '3.51', 'spread': '.74', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': '7 point scale ranging from 0 (no illness) to 6 (most severe patient seen)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Pediatric Anxiety Rating Scale-Revised', 'classes': [{'categories': [{'measurements': [{'value': '17.63', 'spread': '2.67', 'groupId': 'BG000'}, {'value': '16.51', 'spread': '4.14', 'groupId': 'BG001'}, {'value': '17.06', 'spread': '3.52', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Pediatric Anxiety Rating Scale-Revised (PARS) includes a 59-item symptom checklist and 7-item severity scale with parent and clinician-rated scores with range from 0 to 35. Higher scores indicate higher symptom severity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Baseline Characteristics were not collected for Parents and only reflect the Child.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-12-20', 'size': 679508, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2024-08-27T13:21', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Outcomes assessor is blinded'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized assignment to one of two conditions'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2023-12-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-12', 'studyFirstSubmitDate': '2021-05-25', 'resultsFirstSubmitDate': '2024-02-23', 'studyFirstSubmitQcDate': '2021-06-04', 'lastUpdatePostDateStruct': {'date': '2025-03-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-12-08', 'studyFirstPostDateStruct': {'date': '2021-06-10', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pediatric Anxiety Rating Scale', 'timeFrame': 'Baseline (before treatment), post-treatment assessment (on average 12 weeks), one month follow up; Baseline scores reported.', 'description': 'Clinician-rated child anxiety severity throughout the past week. Each item is scored on a 0 to 5 scale (higher scores correspond to greater severity), yielding a total between 0 and 35.'}], 'secondaryOutcomes': [{'measure': 'Anxiety Disorders Interview Schedule (ADIS-IV) With Clinical Severity Ratings', 'timeFrame': 'Up to 24 weeks', 'description': 'Clinician-rated diagnostic interview that includes current anxiety disorders, depression, obsessive-compulsive disorder, and related disorders. Each diagnostic category is coded as present or absent based on symptom criteria and clinical severity ratings (CSRs), which indicate the level of clinical interference. CSRs are scored on a 0-8 scale (0 = not at all; 8 = very, very much). CSRs of 4 or above indicate the clinical levels.'}, {'measure': 'Clinical Global Impression-Severity', 'timeFrame': 'Baseline (before treatment), post-treatment assessment (on average 12 weeks), one month follow up; Baseline scores reported.', 'description': 'Clinician-rated child psychopathology severity rating. A single item is scored 0-6 (0= no illness; 6= extremely severe symptoms).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['obsessive-compulsive disorder', 'children', 'cognitive behavioral therapy', 'anxiety'], 'conditions': ['Obsessive-Compulsive Disorder in Children', 'Social Anxiety Disorder of Childhood', 'Obsessive-Compulsive Disorder in Adolescence', 'Separation Anxiety', 'Generalized Anxiety Disorder', 'Panic Disorder', 'Panic Attacks', 'Panic With Agoraphobia']}, 'referencesModule': {'references': [{'pmid': '38154287', 'type': 'RESULT', 'citation': 'Storch EA, Guzick AG, Ayton DM, Palo AD, Kook M, Candelari AE, Maye CE, McNeel M, Trent ES, Garcia JL, Onyeka OC, Rast CE, Shimshoni Y, Lebowitz ER, Goodman WK. Randomized trial comparing standard versus light intensity parent training for anxious youth. Behav Res Ther. 2024 Feb;173:104451. doi: 10.1016/j.brat.2023.104451. Epub 2023 Dec 17.'}]}, 'descriptionModule': {'briefSummary': 'Anxiety and obsessive-compulsive disorders are the most common mental health disorders in childhood and adolescence. A parenting intervention for youth with anxiety, called Supportive Parenting of Anxious Childhood Emotions ("SPACE"), has been recently developed to help target anxiety in children. In this intervention, therapists meet individually with parents to help them reduce anxiety behaviors in their children and support adaptive behaviors in their children. The purpose for the proposed study is to demonstrate the treatment efficacy of SPACE compared to a low-contact, therapist-supported bibliotherapy version of this intervention.', 'detailedDescription': 'Anxiety and obsessive-compulsive disorders are the most common mental health disorders in childhood and adolescence. Parental accommodation of their children\'s avoidance, escape, safety behaviors are a set of parenting behaviors that have been most strongly associated with child anxiety and obsessive-compulsive disorder. Developing and testing parent-led interventions that target accommodation and parenting styles associated with anxiety has the potential to improve treatment outcomes and reach families who may not otherwise access care (for example, for youth who refuse to attend therapy). A parenting intervention for youth with anxiety has been recently developed to address these goals called Supportive Parenting of Anxious Childhood Emotions ("SPACE"). In this intervention, therapists meet individually with parents to help them reduce accommodation and support adaptive behaviors in their children. SPACE was recently shown to be non-inferior to individual cognitive-behavioral therapy with 88% of youth being classified as responders to SPACE. The purpose for the proposed study is to demonstrate the treatment efficacy of SPACE compared to a low-contact, therapist-supported bibliotherapy version of this intervention, providing efficacy evidence for SPACE as delivered by an independent investigatory group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '7 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The child is between the ages of 7 to 17 at enrollment\n* The child has clinically significant symptoms of anxiety and/or OCD, as indicated by a score of 12 or higher on the Pediatric Anxiety Rating Scale (PARS).\n* The child is appropriate for anxiety-focused treatment (e.g., anxiety is the primary problem as diagnosed using the Anxiety Disorders Interview Schedule (ADIS), and if secondary psychopathology is present it will not interfere with treatment).\n* One parent/guardian is able and willing to participate in assessment and treatment (e.g., has sufficient English fluency, the decisional capacity to participate, and can commit to treatment duration).\n* The participating parent/guardian lives with their child at least 50% of the time.\n* Both parent and child are able to read and understand English.\n* The child is able to communicate verbally.\n* Participants must reside in Texas and parents must be in the state of Texas when taking calls.\n\nExclusion Criteria:\n\n* the child has a diagnosis of child lifetime bipolar disorder, drug of alcohol abuse, intellectual or developmental disability, psychotic disorder, or conduct disorder.\n* the child has severe, current suicidal/homicidal ideation and/or self-injury requiring medical intervention (referrals will be made for appropriate clinical intervention).\n* the child is receiving concurrent evidence-based psychotherapy for anxiety, involving exposure therapy in at least 50% of sessions.\n* the child has initiated or changed dosage of psychotropic medications within 4 weeks before study enrollment OR stimulant or benzodiazepine medications within 2 weeks before study enrollment. If appropriate, the child may be enrolled in the study once medication dosage has stabilized (i.e., 4 weeks for psychotropic medication or 2 weeks for stimulant/benzodiazepine medication).'}, 'identificationModule': {'nctId': 'NCT04922502', 'briefTitle': 'Parent-based Treatment for Youth With Anxiety and Obsessive-compulsive Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Baylor College of Medicine'}, 'officialTitle': 'Parent-based Treatment for Youth With Anxiety and Obsessive-compulsive Disorder: Comparison of Therapist-Led and Therapist Assisted Approaches', 'orgStudyIdInfo': {'id': 'H-49809'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard SPACE', 'description': '12 one hour parent sessions over 12 weeks in which the therapist guides the parent to target anxious behaviors and support adaptive child behaviors.', 'interventionNames': ['Behavioral: Standard SPACE']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bibliotherapy, low therapist contact SPACE', 'description': '4 one hour parent sessions over 12 weeks in which the therapist supports the parent in understanding and implementing content reviewed in the book "Breaking Free of Child Anxiety and OCD".', 'interventionNames': ['Behavioral: Bibliotherapy, low therapist contact SPACE']}], 'interventions': [{'name': 'Standard SPACE', 'type': 'BEHAVIORAL', 'description': '12 one hour parent sessions over 12 weeks in which the therapist guides the parent to target anxious behaviors and support adaptive child behaviors.', 'armGroupLabels': ['Standard SPACE']}, {'name': 'Bibliotherapy, low therapist contact SPACE', 'type': 'BEHAVIORAL', 'description': '4 one hour parent sessions over 12 weeks in which the therapist supports the parent in understanding and implementing content reviewed in the book "Breaking Free of Child Anxiety and OCD".', 'armGroupLabels': ['Bibliotherapy, low therapist contact SPACE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baylor College of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Eric A Storch', 'investigatorAffiliation': 'Baylor College of Medicine'}}}}