[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648446":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":31,"centralContacts":38,"locations":47,"responsibleParty":60,"collaborators":62,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":74,"maxAge":30,"enrollmentInfo":75,"targetDuration":30,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":87,"overallStatus":50,"whyStopped":30,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Khyber Medical University Peshawar","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Culturally Adapted Nurse-Led COPE Intervention","EXPERIMENTAL","Participants randomized to the experimental arm will receive a culturally adapted, nurse-led Creating Opportunities for Parent Empowerment (COPE) intervention in addition to routine hospital care. The intervention consists of four weekly sessions (approximately 45 minutes each) delivered over four weeks by trained nurses. The sessions include psychoeducation about Autism Spectrum Disorder (ASD), cognitive restructuring, coping strategies, positive parenting, emotional regulation, stress management, and long-term family resilience. Educational materials, including audio-visual aids and printed booklets, will be used to facilitate the intervention.",[13],"Behavioral: Culturally Adapted Nurse-Led COPE Intervention",{"label":15,"type":6,"description":16,"interventionNames":17},"Routine Care","Participants randomized to the control arm will receive routine hospital care only. They will not receive the culturally adapted nurse-led COPE intervention during the study period. Psychological wellbeing will be assessed at the same time points as the intervention group using the study outcome measures.",[18],"Other: Routine Hospital Care",[20,26],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"BEHAVIORAL","The intervention is a culturally adapted, nurse-led behavioral and psychoeducational program based on the Creating Opportunities for Parent Empowerment (COPE) framework. It is designed to improve the psychological wellbeing of primary caregivers of children with Autism Spectrum Disorder (ASD) by enhancing coping skills, emotional regulation, problem-solving abilities, and parenting confidence. The intervention comprises four weekly sessions of approximately 45 minutes each and includes education about ASD, cognitive restructuring, stress management, positive parenting strategies, guided problem-solving, and development of long-term coping and family resilience. The program is delivered by trained nurses using standardized educational materials, including presentations, audiovisual aids, and printed booklets.",[9],[25],"Creating Opportunities for Parent Empowerment (COPE), COPE Program Culturally Adapted, COPE",{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"Routine Hospital Care","Participants receive the standard care routinely provided by the hospital for families of children with Autism Spectrum Disorder. No components of the culturally adapted nurse-led COPE intervention are provided during the study period.",[15],null,[32,36],{"name":33,"affiliation":34,"role":35},"Zeenaf Aslam, RN, MSN,PHD*","Institute of Nursing Sciences, Khyber Medical University Peshawar","PRINCIPAL_INVESTIGATOR",{"name":37,"affiliation":34,"role":35},"Dr Dildar Muhammad, PhD",[39,43],{"name":33,"role":40,"phone":41,"phoneExt":30,"email":42},"CONTACT","+92 332 6613345","zeenafch@gmail.com",{"name":44,"role":40,"phone":45,"phoneExt":30,"email":46},"Dr Syed Muhammad Shabbir Ali Naqvi, PhD*","+923460113227","coordinator.ctu@kmu.edu.pk",[48],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":30,"geoPoint":30,"contacts":56},"Children Hospital Complex and Institute of Child Health","RECRUITING","Faisalābad","Punjab Province","38000","Pakistan","PK",[57,59],{"name":58,"role":40,"phone":41,"phoneExt":30,"email":42},"Zeenaf Aslam, RN,MSN,PhD*",{"name":44,"role":40,"phone":45,"phoneExt":30,"email":46},{"type":61,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR",[63],{"name":64,"class":6},"Children Hospital Faisalabad","100648446","feasibility-of-a-culturally-adapted-nurse-led-cope-intervention-for-caregivers-of-children-with-autism-spectrum-disorder-100648446",false,"NCT07722949","Feasibility of a Culturally Adapted Nurse-Led COPE Intervention for Caregivers of Children With Autism Spectrum Disorder","Feasibility of Culturally Adapted, Nurse-Led COPE Intervention on Psychological Wellbeing of Primary Caregivers of Child With Autism Spectrum Disorder (CASD)","COPE-ASD","Inclusion Criteria:\n\n* Male or female primary caregivers aged 18 years or older.\n* Primary caregiver of a child with a confirmed diagnosis of Autism Spectrum Disorder (ASD).\n* Able to communicate in Urdu.\n* Willing and able to provide written informed consent.\n* Available to attend all intervention sessions and follow-up assessments.\n\nExclusion Criteria:\n\n* Caregivers currently participating in another structured psychosocial, behavioral, or parenting intervention.\n* Caregivers with a diagnosed severe psychiatric illness or cognitive impairment that would interfere with participation.\n* Caregivers unable to communicate effectively in Urdu.\n* Caregivers who decline or are unable to provide informed consent.\n* Caregivers who are unavailable to complete the intervention or follow-up assessments.","ALL","18 Years",{"count":76,"type":77},77,"ESTIMATED","INTERVENTIONAL",[80],"NA","This study aims to evaluate the feasibility of a culturally adapted, nurse-led Creating Opportunities for Parent Empowerment (COPE) intervention to improve the psychological wellbeing of primary caregivers of children with Autism Spectrum Disorder (ASD) in Pakistan. The study will use an exploratory sequential mixed-methods design comprising a qualitative needs assessment followed by a pilot randomized controlled feasibility trial. Qualitative interviews will identify caregivers' training needs and inform the cultural adaptation of the COPE intervention. Eligible caregivers will then be randomly assigned to either an intervention group receiving the culturally adapted COPE program in addition to routine care or a control group receiving routine care alone. The intervention consists of four weekly nurse-led sessions focusing on psychoeducation, cognitive restructuring, coping strategies, positive parenting, emotional regulation, and family resilience. Psychological wellbeing will be assessed using the Depression Anxiety Stress Scale-21 (DASS-21) at baseline and one month after the intervention. The study will also evaluate recruitment, retention, intervention adherence, acceptability, and implementation feasibility to inform the design of a future definitive randomized controlled trial.",[83,84,85,86],"Autism Spectrum Disorder","Psychological Distress","Depression","Anxiety",[83,88,89,90,91],"Caregivers","Psychological Wellbeing","Feasibility Trial","Randomized controlled trial","2026-07-20",{"date":94,"type":95},"2026-07-23","ACTUAL",{"date":97,"type":95},"2026-07-15",{"date":99,"type":77},"2027-05-25",{"name":5,"class":6},1]