Ignite Creation Date:
2025-12-24 @ 4:58 PM
Ignite Modification Date:
2026-02-21 @ 5:56 AM
Study NCT ID:
NCT05933850
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-09-19
First Post:
2023-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Culturally Adapted Strong Families Programme for Families Living in Gilgit Baltistan, Pakistan
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-03', 'studyFirstSubmitDate': '2023-05-25', 'studyFirstSubmitQcDate': '2023-07-02', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility and acceptability indicators', 'timeFrame': 'From baseline to end of intervention at 3 weeks (post randomisation)', 'description': "We will record feasibility indicators in terms of families' rates of recruitment and attendance to programme, and programme completeness. To evaluate cultural acceptability of programme by families, interviews with caregivers will be conducted to explore family members' opinions on the acceptability of the programme, any barriers or facilitators to participation."}], 'secondaryOutcomes': [{'measure': 'Strengths and Difficulties Questionnaire', 'timeFrame': 'At baseline, week 5 and week 9 of post baseline', 'description': 'The Strengths and Difficulties Questionnaire is a brief behavioural screening questionnaire and ask about 25 attributes, some positive and others negative. This will be administered to both child and the caregiver.'}, {'measure': 'Parenting and Family Adjustment Scale', 'timeFrame': 'At baseline, week 5 and week 9 of post baseline', 'description': 'This will measures parenting practices and parental adjustment. This scale has been developed to be used in low resource settings.'}, {'measure': 'Child and Youth Resilience Measure', 'timeFrame': 'At baseline, week 5 and week 9 of post baseline', 'description': 'This is a screening tool to explore the resources available that may bolster resilience.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mental Health']}, 'referencesModule': {'references': [{'pmid': '38951006', 'type': 'DERIVED', 'citation': 'El-Khani A, Asif M, Shahzad S, Bux MS, Maalouf W, Rafiq NUZ, Khoso AB, Chaudhry IB, Van Hout MC, Zadeh Z, Tahir A, Memon R, Chaudhry N, Husain N. Assessing the efficacy of a brief universal family skills programme on child behaviour and family functioning in Gilgit-Baltistan, Pakistan: protocol for a feasibility randomised controlled trial of the Strong Families programme. BMJ Open. 2024 Jul 1;14(6):e081557. doi: 10.1136/bmjopen-2023-081557.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this exploratory study is to test the Strong Family (SF) programme in improving family functioning when implemented in Gilgit-Baltistan. Participants will be randomized to one of the two study arms 1)- Intervention group in which participants will receive 3 group sessions of SF programme (8-12 families per group) 2)- Control group (control group will be in the waiting list and receive SF training sessions once the study will be completed).', 'detailedDescription': "This will be multicentre feasibility randomised controlled trial to test the effectiveness of the SF programme in improving family skills outcomes and caregiver and child mental health, as reported by caregivers when implemented in Gilgit-Baltistan. The study will record families' rates of recruitment and attendance to SF programme, evaluate the completeness of programme delivery, cultural acceptability through qualitative interviews and assess the fidelity of training delivery. A small pilot study with N=10 families (a female caregiver (mother) and one child between the age of 8-15 years from each family) will be conducted before main RCT. The study will be conducted in three districts including; Gilgit, Hunza and Skardu in Gilgit Baltistan, Pakistan. We will interview a subset of participants i.e. up to 5 caregivers from each study site (N=15 caregivers) to explore participants' opinions on the acceptability of the programme and to explore any barriers or facilitators to participation."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': "Respecting the cultural context, either males or females' caregivers can be engaged at one time in our study setting. As females are most often the primary caregivers in Pakistan, female primary caregivers and their children (of either gender) will be invited to participate in this study.", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female primary caregiver to a child aged between 8-15 years\n* Able to speak and understand Urdu language\n* Capable to give informed consent\n\nExclusion Criteria:\n\n* Families that had already taken part in another family skills training programme in the past 6 months or where the caregiver lived separately from the child\n* Not the primary caregiver of the child\n* Unlikely to be available for the duration of the whole study and outcome assessments (e.g., temporary residence).'}, 'identificationModule': {'nctId': 'NCT05933850', 'briefTitle': 'Culturally Adapted Strong Families Programme for Families Living in Gilgit Baltistan, Pakistan', 'organization': {'class': 'OTHER', 'fullName': 'Pakistan Institute of Living and Learning'}, 'officialTitle': 'Culturally Adapted Strong Families Programme to Improve Child Behavior and Family Functioning in Families Living in Gilgit Baltistan, Pakistan', 'orgStudyIdInfo': {'id': 'PILL-SFP-GB-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Strong Family Programme Intervention', 'description': 'There will be 3 weekly group sessions of the strong family programme with caregivers and children (8-12 families per group).', 'interventionNames': ['Behavioral: Strong Families Programme Intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Waitlist control group', 'description': 'This group will be on the waiting list and receive SF programme training sessions once the study will be completed.', 'interventionNames': ['Behavioral: Strong Families Programme Intervention']}], 'interventions': [{'name': 'Strong Families Programme Intervention', 'type': 'BEHAVIORAL', 'description': 'This is a family skills programme providing an evidence-informed prevention to support caregivers to be better parents and strengthen positive age-specific and age-appropriate family functioning and interactions to help prevent drug use, violence and other negative social consequences in their children.', 'armGroupLabels': ['Strong Family Programme Intervention', 'Waitlist control group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'MUQADDAS ASIF', 'role': 'CONTACT', 'email': 'muqaddasasif@pill.org.pk', 'phone': '03364057787'}], 'overallOfficials': [{'name': 'Salman Shahzad', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pakistan Institute of Living and Learning'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'After 2 years of trial completion.', 'ipdSharing': 'YES', 'description': 'De-identified individual participant data (IPD) will be shared with other researchers, encompassing essential information such as demographic details, primary and secondary outcome measures, intervention exposure metrics, and process evaluation data. Rigorous measures will be implemented to ensure the complete de-identification of the data and safeguard the anonymity of individual participants.', 'accessCriteria': 'The data could be requested from the corresponding author with a reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pakistan Institute of Living and Learning', 'class': 'OTHER'}, 'collaborators': [{'name': 'UNODC', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}