[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659180":3},{"organization":4,"outcomesModule":7,"designInfo":81,"detailedDescription":88,"studyPopulation":80,"armGroups":89,"interventions":96,"overallOfficials":102,"centralContacts":106,"locations":116,"responsibleParty":132,"collaborators":134,"id":138,"slug":139,"hasResults":140,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":144,"eligibilityCriteria":145,"healthyVolunteers":140,"sex":146,"minAge":147,"maxAge":148,"enrollmentInfo":149,"targetDuration":80,"studyType":152,"phases":153,"briefSummary":154,"conditions":155,"keywords":158,"overallStatus":118,"whyStopped":80,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":173},{"fullName":5,"class":6},"Jordan University of Science and Technology","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":80},[9,13],{"measure":10,"description":11,"timeFrame":12},"Primary Outcome 1 -Change From Baseline in Depressive Symptoms Measured Using the Patient Health Questionnaire-9 (PHQ-9) or Patient Health Questionnaire-Adolescent Version (PHQ-A)","Depressive symptoms will be assessed using the Patient Health Questionnaire-9 (PHQ-9) for adult women and the Patient Health Questionnaire-Adolescent version (PHQ-A) for adolescent girls. Each participant will complete only the age-appropriate 9-item instrument. Each item is scored from 0 to 3, and the 9 item scores are summed to produce a total score ranging from 0 to 27. Higher scores indicate greater depressive symptom severity and lower scores indicate fewer depressive symptoms. Change from baseline will be calculated as the follow-up total score minus the baseline total score; negative change scores indicate improvement.","Baseline and approximately 3 months after baseline\u002Fcompletion of the intervention",{"measure":14,"description":15,"timeFrame":12},"Primary Outcome 2 - Change From Baseline in Anxiety Symptoms Measured Using the Generalized Anxiety Disorder-7 (GAD-7)","Anxiety symptoms will be assessed using the Generalized Anxiety Disorder-7 (GAD-7), a 7-item self-report measure. Each item is scored from 0 to 3. Item scores are summed to produce a total score ranging from 0 to 21. Higher scores indicate greater anxiety symptom severity and lower scores indicate fewer anxiety symptoms. Change from baseline will be calculated as the follow-up total score minus the baseline total score; negative change scores indicate improvement.",[17,21,24,27,30,33,37,40,43,47,50,53,56,59,62,65,68,71,74,77],{"measure":18,"description":19,"timeFrame":20},"Change From Baseline in Psychological Well-Being Measured Using the World Health Organization-Five Well-Being Index (WHO-5)","Psychological well-being will be assessed using the World Health Organization-Five Well-Being Index (WHO-5), a 5-item measure of subjective psychological well-being. Each item is scored from 0 to 5. The 5 item scores are summed to produce a raw total score ranging from 0 to 25. The raw total is multiplied by 4 to produce the reported WHO-5 score ranging from 0 to 100. Higher scores indicate better psychological well-being. Change from baseline will be calculated as the follow-up score minus the baseline score; positive change scores indicate improvement.","Baseline and approximately 3 months after baseline.",{"measure":22,"description":23,"timeFrame":20},"Change From Baseline in Post-Traumatic Stress Symptoms Measured Using the Posttraumatic Stress Disorder Checklist for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (PCL-5)","Post-traumatic stress symptoms will be assessed using the Posttraumatic Stress Disorder Checklist for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (PCL-5), a 20-item self-report measure. Each item is scored from 0 (not at all) to 4 (extremely). The 20 item scores are summed to produce a total score ranging from 0 to 80. Higher scores indicate greater post-traumatic stress symptom severity and lower scores indicate fewer symptoms. Change from baseline will be calculated as the follow-up total score minus the baseline total score; negative change scores indicate improvement.",{"measure":25,"description":26,"timeFrame":20},"Change From Baseline in Electronic Health Literacy Measured Using the eHealth Literacy Scale (eHEALS)","Electronic health literacy will be assessed using the eHealth Literacy Scale (eHEALS), an 8-item self-report measure. Each item is rated on a 5-point scale from 1 (strongly disagree) to 5 (strongly agree). The 8 item scores are summed to produce a total score ranging from 8 to 40. Higher scores indicate greater perceived electronic health literacy. Change from baseline will be calculated as the follow-up total score minus the baseline total score; positive change scores indicate improvement.",{"measure":28,"description":29,"timeFrame":20},"Change From Baseline in Reproductive-Health Knowledge Measured Using the 12-Item Reproductive-Health Literacy\u002FKnowledge Module","Reproductive-health knowledge will be assessed using the study-specific 12-item Reproductive-Health Literacy\u002FKnowledge Module. Each item has True, False, and Don't know response options. A correct response is scored 1, while an incorrect or Don't know response is scored 0. The 12 item scores are summed to produce a total score ranging from 0 to 12. Higher scores indicate greater reproductive-health knowledge. Change from baseline will be calculated as the follow-up total score minus the baseline total score; positive change scores indicate improvement.",{"measure":31,"description":32,"timeFrame":20},"Change From Baseline in Reproductive-Health Attitudes and Self-Efficacy Measured Using a 7-Item Study-Specific Questionnaire","Reproductive-health attitudes and self-efficacy will be assessed using a study-specific 7-item questionnaire comprising 3 reproductive-health attitude items and 4 self-efficacy items. Each item is rated on a 5-point Likert scale from 1 (completely disagree) to 5 (completely agree). To obtain one reported value, the mean of all 7 items will be calculated for each participant, producing an overall score ranging from 1 to 5. Higher scores indicate more positive reproductive-health attitudes and greater self-efficacy. Change from baseline will be calculated as the follow-up mean score minus the baseline mean score; positive change scores indicate improvement.",{"measure":34,"description":35,"timeFrame":36},"Acceptability of the E-Clinic Measured Using the Acceptability of Intervention Measure (AIM)","Acceptability of the e-clinic will be assessed using the 4 scored items in the Acceptability of Intervention Measure (AIM) section of the study questionnaire. The items assess overall satisfaction, appeal, acceptability of using the e-clinic, and willingness to continue using the e-clinic. Each item is rated on a 5-point Likert scale from 1 (completely disagree) to 5 (completely agree). The mean of the 4 scored items will be calculated, producing a score ranging from 1 to 5. Higher scores indicate greater perceived acceptability of the e-clinic.","Approximately 3 months after baseline.",{"measure":38,"description":39,"timeFrame":36},"Participant-Reported Usability of The E-Clinic","Usability will be assessed using the study-specific 5-item Usability and Accessibility domain of the E-Clinic Implementation Research Questionnaire. The items assess whether the e-clinic content was clear and easy to understand, whether the platform was easy to navigate and use, whether it could be accessed when needed, whether use was feasible given time, device and internet access, and whether it was suitable for the participant's literacy and communication needs. Each item is rated from 1 (completely disagree) to 5 (completely agree). The mean of the 5 items will be calculated, producing one domain score ranging from 1 to 5. Higher scores indicate greater perceived usability and accessibility.",{"measure":41,"description":42,"timeFrame":36},"Participant-Reported Privacy, Safety, and Cultural Fit Measured Using the 3-Item Privacy, Safety, and Cultural Fit Domain of the E-Clinic Implementation Research Questionnaire","Privacy, safety, and cultural fit will be assessed using the study-specific 3-item Privacy, Safety, and Cultural Fit domain of the E-Clinic Implementation Research Questionnaire. The items assess whether the participant felt safe using the e-clinic, whether the e-clinic protected privacy and confidentiality, and whether the e-clinic was culturally respectful and appropriate. Each item is rated from 1 (completely disagree) to 5 (completely agree). The mean of the 3 items will be calculated, producing one domain score ranging from 1 to 5. Higher scores indicate more favorable perceptions of privacy, safety, and cultural fit.",{"measure":44,"description":45,"timeFrame":46},"Number of Individual Psychosocial Consultation Sessions Completed","Engagement with one-to-one psychosocial support will be assessed as the total number of individual psychosocial consultation sessions completed by each participant during the follow-up period. The reported value is a count of completed sessions.","From enrollment through approximately 3 months after baseline.",{"measure":48,"description":49,"timeFrame":46},"Participation in Virtual Group or Peer-Support Sessions","Participants will report whether they used virtual group or peer-support sessions during the follow-up period (No\u002FYes). The number and percentage of participants reporting participation will be reported.",{"measure":51,"description":52,"timeFrame":46},"Number of Educational Modules Completed and Used","Engagement with educational content will be assessed as the number of e-clinic educational modules completed and used by each participant during the follow-up period. The reported value is a count of modules.",{"measure":54,"description":55,"timeFrame":46},"Use of E-Clinic Self-Help Exercises or Activities","Participants will report whether they used e-clinic self-help exercises or activities during the follow-up period (No\u002FYes). The number and percentage of participants reporting use will be reported.",{"measure":57,"description":58,"timeFrame":46},"Use of Referral Information or Referral Support","Participants will report whether they used referral information or referral support provided through the e-clinic during the follow-up period (No\u002FYes). The number and percentage of participants reporting use will be reported.",{"measure":60,"description":61,"timeFrame":36},"Participant-Reported Relevance and Usefulness Measured Using the 4-Item Relevance and Usefulness Domain of the E-Clinic Implementation Research Questionnaire","Perceived relevance and usefulness will be assessed using the study-specific 4-item Relevance and Usefulness domain of the E-Clinic Implementation Research Questionnaire. The items assess whether the content was relevant to the participant's needs, improved knowledge about reproductive and emotional health, improved understanding of emotional distress, stress, anxiety, or sadness, and improved the participant's ability to determine when professional care is needed. Each item is rated from 1 (completely disagree) to 5 (completely agree). The mean of the 4 items will be calculated, producing one domain score ranging from 1 to 5. Higher scores indicate greater perceived relevance and usefulness.",{"measure":63,"description":64,"timeFrame":36},"Participant-Reported Emotional Support and Overall Success Measured Using the 3-Item Emotional Support and Overall Success Domain of the E-Clinic Implementation Research Questionnaire","Emotional support and overall success will be assessed using the study-specific 3-item Emotional Support and Overall Success domain of the E-Clinic Implementation Research Questionnaire. The items assess whether the e-clinic helped the participant feel less alone in dealing with concerns, whether the participant would recommend the e-clinic to others with similar needs, and overall satisfaction with the e-clinic. Each item is rated from 1 (completely disagree) to 5 (completely agree). The mean of the 3 items will be calculated, producing one domain score ranging from 1 to 5. Higher scores indicate greater perceived emotional support and overall success.",{"measure":66,"description":67,"timeFrame":36},"Appropriateness of the E-Clinic Measured Using the Intervention Appropriateness Measure (IAM)","Perceived appropriateness of the e-clinic will be assessed using the 4-item Intervention Appropriateness Measure (IAM) section of the study questionnaire. The items assess whether the e-clinic effectively addresses the participant's health needs, is relevant to the participant's personal situation, provides support appropriate to the participant's concerns, and is a good fit for the type of care needed. Each item is rated from 1 (completely disagree) to 5 (completely agree). The mean of the 4 items will be calculated, producing a score ranging from 1 to 5. Higher scores indicate greater perceived appropriateness of the e-clinic.",{"measure":69,"description":70,"timeFrame":36},"Feasibility of the E-Clinic Measured Using the Feasibility of Intervention Measure (FIM)","Feasibility of the e-clinic will be assessed using the 4-item Feasibility of Intervention Measure (FIM) section of the study questionnaire. The items assess ease of accessing and using the e-clinic, ability to use it without difficulty in daily life, fit with the participant's routine and schedule, and practicality of continued use over time. Each item is rated from 1 (completely disagree) to 5 (completely agree). The mean of the 4 items will be calculated, producing a score ranging from 1 to 5. Higher scores indicate greater perceived feasibility of using the e-clinic.",{"measure":72,"description":73,"timeFrame":46},"Receipt of an E-Clinic Referral Recommendation","Participants will report whether an e-clinic provider recommended that they seek additional support or referral during the follow-up period (No\u002FYes). The number and percentage of participants who received a referral recommendation will be reported.",{"measure":75,"description":76,"timeFrame":46},"Referral Completion Status Among Participants Receiving an E-Clinic Referral Recommendation","Among participants who received an e-clinic referral recommendation, referral completion status will be assessed at follow-up using the response categories completed, partially completed, not completed, or not applicable, consistent with the study questionnaire. The number and percentage of referred participants in each category will be reported.",{"measure":78,"description":79,"timeFrame":46},"Main Reported Barrier to Referral Completion Among Participants Who Did Not Complete a Recommended Referral","Among participants who did not complete a recommended referral, the main reported barrier will be categorized as cost, transport, family or social barriers, stigma or embarrassment, privacy concerns, time, service unavailable, or other. The number and percentage of participants in each barrier category will be reported.",null,{"allocation":82,"interventionModel":83,"interventionModelDescription":84,"primaryPurpose":85,"observationalModel":80,"timePerspective":80,"maskingInfo":86},"NA","SINGLE_GROUP","All enrolled participants receive access to the integrated digital e-clinic intervention. Outcomes are assessed at baseline and again after completion of the intervention or approximately three months after baseline. There is no concurrent control group.","HEALTH_SERVICES_RESEARCH",{"masking":87,"maskingDescription":80,"whoMasked":80},"NONE","The study uses a single-group pre-post implementation design to evaluate an integrated e-clinic for women and adolescent girls in Jordan. The digital intervention integrates mental health and psychosocial support with reproductive and maternal health information and referral services.\n\nParticipants receive access to individualized psychosocial support, educational and self-help resources, and referral support according to their assessed needs. The intervention incorporates safety and referral procedures for participants requiring urgent or specialized mental health or medical services.\n\nParticipants complete a baseline assessment before beginning use of the e-clinic. Follow-up assessment is conducted after completion of the intervention or approximately three months from baseline. Process indicators include the number and type of psychosocial sessions received, use of educational and self-help components, peer or group support where applicable, referral use and completion, and engagement with the digital platform.\n\nOutcomes include depressive symptoms, anxiety symptoms, psychological well-being, post-traumatic stress symptoms, electronic health literacy, reproductive health knowledge, reproductive health attitudes and self-efficacy, acceptability, appropriateness, feasibility, accessibility, privacy, cultural appropriateness, perceived usefulness, service utilization, satisfaction and continuity of care.\n\nThe intervention is delivered remotely through a secure electronic e-clinic platform. Participants may access the intervention from their own location, and no routine in-person attendance at the study facility is required",[90],{"label":91,"type":92,"description":93,"interventionNames":94},"Experimental: Integrated E-Clinic Intervention","EXPERIMENTAL","Participants receive the integrated digital mental health, psychosocial and reproductive health e-clinic intervention, including individualized psychosocial support, educational and self-help resources, digital health information and referral support according to need. Baseline and approximately three-month follow-up assessments are completed.",[95],"Behavioral: Integrated Digital MHPSS-Reproductive Health E-Clinic",[97],{"type":98,"name":99,"description":100,"armGroupLabels":101,"otherNames":80},"BEHAVIORAL","Integrated Digital MHPSS-Reproductive Health E-Clinic","A culturally tailored digital intervention providing integrated mental health and psychosocial support and reproductive health information to women and adolescent girls in Jordan. The intervention includes individualized psychosocial support, scheduled provider interactions, evidence-based educational content, self-help resources, peer\u002Fgroup support where applicable, and referral pathways to appropriate health, mental health and psychosocial services. Participants with urgent or specialized needs are referred according to the study safety and referral protocol.",[91],[103],{"name":104,"affiliation":5,"role":105},"Mohammad S Alyahya","PRINCIPAL_INVESTIGATOR",[107,112],{"name":108,"role":109,"phone":110,"phoneExt":80,"email":111},"Mohammad Sharif Alyahya, PhD","CONTACT","+962 775582824","msalyahya@just.edu.jo",{"name":113,"role":109,"phone":114,"phoneExt":80,"email":115},"Nihaya Al-Sheyab, PhD","+962 790751996","nasheyab@just.edu.jo",[117],{"facility":5,"status":118,"city":119,"state":80,"zip":120,"country":121,"countryCode":122,"cosmosGeoPoint":123,"geoPoint":128,"contacts":129},"RECRUITING","Irbid","22110","Jordan","JO",{"type":124,"coordinates":125},"Point",[126,127],35.85,32.55556,{"lat":127,"lon":126},[130],{"name":131,"role":109,"phone":110,"phoneExt":80,"email":111},"Mohammad Alyahya, PhD",{"type":133,"investigatorFullName":80,"investigatorTitle":80,"investigatorAffiliation":80,"oldNameTitle":80,"oldOrganization":80},"SPONSOR",[135],{"name":136,"class":137},"International Development Research Centre, Canada","OTHER_GOV","100659180","integrated-digital-psychosocial-and-reproductive-health-e-clinic-for-women-and-adolescent-girls-in-jordan-100659180",false,"NCT07861945","Integrated Digital Psychosocial and Reproductive Health E-Clinic for Women and Adolescent Girls in Jordan","Integrating Psychosocial and Mental Health Support in Maternal, Prenatal, and Perinatal Health for Better Adolescent Health in Jordan","AMAL-CLINIC","Inclusion Criteria:\n\n* Female participants aged 14 to 65 years.\n* Jordanian women and adolescent girls and Syrian refugee women and adolescent girls residing in Jordan.\n* Eligible to receive psychosocial, mental-health and\u002For reproductive-health support through the e-clinic.\n* Able to access the e-clinic using an internet-connected device or another approved method of access.\n* Willing to participate in the e-clinic intervention and study assessments. Able to provide informed consent.\n* For participants below the age at which independent consent is permitted under the approved protocol, parental\u002Flegal guardian consent and adolescent assent will be obtained.\n\nExclusion Criteria:\n\n* Acute psychiatric or psychological condition requiring immediate specialist or emergency intervention beyond the scope of the e-clinic.\n* Imminent risk of suicide or serious self-harm requiring emergency assessment or intervention.\n* Acute medical or reproductive-health emergency requiring urgent face-to-face care.\n* Inability to provide informed consent\u002Fassent or participate meaningfully in the intervention and assessments.\n* Circumstances in which remote participation cannot be conducted safely according to the study safety protocol.","FEMALE","14 Years","65 Years",{"count":150,"type":151},250,"ESTIMATED","INTERVENTIONAL",[82],"This implementation study evaluates an integrated digital e-clinic designed to provide mental health, psychosocial, and reproductive health support to women and adolescent girls in Jordan, including Jordanian and Syrian refugee participants and other vulnerable groups. The e-clinic provides individualized psychosocial support, evidence-based educational content, self-help resources, scheduled interactions with trained healthcare providers, and referral pathways for participants requiring additional or specialized services. Participants complete baseline assessments before using the e-clinic and follow-up assessments approximately three months after baseline or following completion of the intervention. The study evaluates changes in mental health and well-being outcomes as well as acceptability, appropriateness, feasibility, accessibility, digital health literacy, reproductive health knowledge and attitudes, service utilization, participant satisfaction, privacy, and engagement with the e-clinic.",[156,157],"Mental Health","Reproductive Health",[159,160,161,162,163],"Digital Health","e-Clinic","Psychosocial Support","MHPSS","Adolescent Girls","2026-10-01",{"date":166,"type":167},"2026-10-06","ACTUAL",{"date":169,"type":167},"2026-08-29",{"date":171,"type":151},"2027-09",{"name":5,"class":6},1]