Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-27 @ 11:00 PM
Study NCT ID:
NCT04913194
Status:
UNKNOWN
Last Update Posted:
2022-06-16
First Post:
2021-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Two-Session Exposure Treatment and Parent Training for ARFID
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000080146', 'term': 'Avoidant Restrictive Food Intake Disorder'}, {'id': 'D000081010', 'term': 'Food Fussiness'}], 'ancestors': [{'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two-arm waitlist control trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2023-06-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-15', 'studyFirstSubmitDate': '2021-04-12', 'studyFirstSubmitQcDate': '2021-06-02', 'lastUpdatePostDateStruct': {'date': '2022-06-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recruitment Feasibility', 'timeFrame': 'Enrollment', 'description': 'Recruitment rates will be measured by the average number of participants recruited each month.'}, {'measure': 'Retention Feasibility', 'timeFrame': 'Through study completion, up to 9 months', 'description': 'Retention rates will be measured as the percentage of families who begin treatment and complete all follow-up time points.'}, {'measure': 'Acceptability of exposure protocol', 'timeFrame': 'Through study completion, up to 9 months', 'description': 'Acceptability of exposure will be measured as a percentage of number of daily food exposures the family completes at all follow-up time points.'}, {'measure': 'Credibility of treatment', 'timeFrame': 'After week 2 of treatment', 'description': 'The Credibility and Expectancy Questionnaire is a 6-item measure of treatment credibility and how much participants think and feel treatment will work.'}, {'measure': 'Acceptability of treatment', 'timeFrame': 'After week 2 of treatment', 'description': 'Parents will self-report the acceptability of treatment by selecting the extent to which they agree with statements such as "I would refer this treatment to a friend" or "I am satisfied with this treatment."'}, {'measure': 'Acceptability of treatment at 1-month follow-up', 'timeFrame': '1 month', 'description': 'Parents will self-report the acceptability of treatment by selecting the extent to which they agree with statements such as "I would refer this treatment to a friend" or "I am satisfied with this treatment."'}], 'secondaryOutcomes': [{'measure': 'Pica, ARFID, Rumination Disorder Interview (PARDI)', 'timeFrame': 'Change between intake and 3-month follow-up', 'description': 'The PARDI is a semi-structured interview assessing for diagnostic criteria of ARFID, as well as subtype classification and severity ratings. Parents will be assessed using the PARDI.'}, {'measure': 'Treatment Efficacy: Foods in Regular Rotation', 'timeFrame': 'Through study completion, up to 9 months', 'description': 'Parents will self-report the number of new foods a child has included in "regular rotation" i.e., is able to eat a full serving size regularly.'}, {'measure': 'Behavioral Pediatric Feeding Assessment Scale', 'timeFrame': 'Through study completion, up to 9 months', 'description': "The Behavioral Pediatric Feeding Assessment Scale is a well-validated measure of child's eating behaviors and parental perception of eating behaviors."}, {'measure': 'Treatment Efficacy: Goal Progress', 'timeFrame': 'Through study completion, up to 9 months', 'description': 'Treatment goals will be assessed using the ARFID-specific treatment goal checklist established by Bryant-Waugh in 2020 via the Maudsley Centre for Child and Adolescent Eating Disorders.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Parent training', 'Exposure', 'ARFID', 'Picky eating', 'Brief intervention', 'Virtual intervention'], 'conditions': ['Avoidant Restrictive Food Intake Disorder']}, 'referencesModule': {'references': [{'pmid': '39031449', 'type': 'DERIVED', 'citation': 'Breiner CE, Miller ML, Hormes JM. ARFID Parent Training Protocol ("ARFID-PTP"): Results of a Randomized Pilot Trial Evaluating a Brief, Parent-Training Program for Avoidant/Restrictive Food Intake Disorder. Int J Eat Disord. 2024 Nov;57(11):2306-2317. doi: 10.1002/eat.24269. Epub 2024 Jul 19.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to assess the acceptability, feasibility, and preliminary efficacy of a two-session, virtual parent-training exposure protocol for children ages 5-12 who experience picky eating consistent with an Avoidant-Restrictive Food Intake Disorder (ARFID) diagnosis.', 'detailedDescription': 'Potential subjects aged 5 to 12 years with picky eating symptoms consistent with an ARFID diagnosis, as determined by the Pica, ARFID, Rumination Disorder Interview, a semi-structured diagnostic interview, will be recruited via social media and local doctor\'s offices. Eligible subjects will complete informed consent and an intake session. Participants will then be randomized to an immediate treatment group, in which they will begin treatment the following week, or a 4-week waitlist condition, in which they will wait four weeks to begin treatment. All participants will have the opportunity to receive the treatment, ARFID Parent Training Program or "ARFID-PTP." ARFID-PTP was adapted from a seven-session parent-training for extremely picky eating behaviors to examine the efficacy of a two-session, virtual protocol on increasing food intake and decreasing selective eating. The two virtual treatment sessions will include psychoeducation, parent-training skills, and exposure protocol. There will be 5 major assessment time points: intake, end of treatment, 4-weeks post-treatment, 3-months post-treatment, and 6-months post-treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children ages 5-12\n* Child meets criteria for ARFID using the Pica, ARFID, Rumination Disorder Interview\n* Established care with a primary care provider\n* Not engaging in other medication or psychotherapy for ARFID during this treatment trial\n* Fluently speak and read English\n\nExclusion Criteria:\n\n* Child or parent experiencing suicidal thoughts\n* Child or parent experiencing psychotic symptoms\n* Child has a cognitive functioning disability'}, 'identificationModule': {'nctId': 'NCT04913194', 'acronym': 'ARFID-PTP', 'briefTitle': 'A Two-Session Exposure Treatment and Parent Training for ARFID', 'organization': {'class': 'OTHER', 'fullName': 'University at Albany'}, 'officialTitle': 'A Pilot Trial of A Two-Session Exposure Treatment and Parent Training for Picky Eating Consistent With an Avoidant-Restrictive Food Intake Disorder (ARFID) Diagnosis', 'orgStudyIdInfo': {'id': '21E001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Immediate Treatment', 'description': 'Participants in this arm will receive the intervention within 2 weeks of completing the intake session.', 'interventionNames': ['Behavioral: ARFID-PTP']}, {'type': 'OTHER', 'label': 'Waitlist Control', 'description': 'Participants in this arm will not receive any intervention for two weeks. Participants will complete the treatment after 4-6 weeks of being on the waitlist after their intake session.', 'interventionNames': ['Behavioral: ARFID-PTP']}], 'interventions': [{'name': 'ARFID-PTP', 'type': 'BEHAVIORAL', 'description': 'ARFID-PTP is a two-session virtual protocol using psychoeducation, parent training skills, and exposure to decrease picky eating symptoms consistent with an ARFID diagnosis.', 'armGroupLabels': ['Immediate Treatment', 'Waitlist Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12222', 'city': 'Albany', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Adrienne Bonilla, Esq', 'role': 'CONTACT', 'email': 'abonilla@albany.edu', 'phone': '518-437-3850'}, {'name': 'Courtney E Breiner, MA', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Julia M Hormes, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'McKenzie Miller, MA', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University at Albany, State University of New York', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}], 'centralContacts': [{'name': 'Courtney E Breiner, MA', 'role': 'CONTACT', 'email': 'cbreiner@albany.edu', 'phone': '518-376-2543'}], 'overallOfficials': [{'name': 'Courtney E Breiner, MA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University at Albany, State University of New York'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University at Albany', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}