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Integrated Digital Psychosocial and Reproductive Health E-Clinic for Women and Adolescent Girls in Jordan (AMAL-CLINIC)

1 ottobre 2026 aggiornato da: Jordan University of Science and Technology

Integrating Psychosocial and Mental Health Support in Maternal, Prenatal, and Perinatal Health for Better Adolescent Health in Jordan

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.

Panoramica dello studio

Descrizione dettagliata

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.

Participants 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.

Participants 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.

Outcomes 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.

The 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

Tipo di studio

Interventistico

Iscrizione (Stimato)

250

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

      • Irbid, Giordania, 22110
        • Reclutamento
        • Jordan University of Science and Technology
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 14 anni a 65 anni (Bambino, Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Femmina

Descrizione

Inclusion Criteria:

  • Female participants aged 14 to 65 years.
  • Jordanian women and adolescent girls and Syrian refugee women and adolescent girls residing in Jordan.
  • Eligible to receive psychosocial, mental-health and/or reproductive-health support through the e-clinic.
  • Able to access the e-clinic using an internet-connected device or another approved method of access.
  • Willing to participate in the e-clinic intervention and study assessments. Able to provide informed consent.
  • For participants below the age at which independent consent is permitted under the approved protocol, parental/legal guardian consent and adolescent assent will be obtained.

Exclusion Criteria:

  • Acute psychiatric or psychological condition requiring immediate specialist or emergency intervention beyond the scope of the e-clinic.
  • Imminent risk of suicide or serious self-harm requiring emergency assessment or intervention.
  • Acute medical or reproductive-health emergency requiring urgent face-to-face care.
  • Inability to provide informed consent/assent or participate meaningfully in the intervention and assessments.
  • Circumstances in which remote participation cannot be conducted safely according to the study safety protocol.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Ricerca sui servizi sanitari
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Experimental: Integrated E-Clinic Intervention

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.

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/group 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
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)
Lasso di tempo: Baseline and approximately 3 months after baseline/completion of the intervention

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/completion of the intervention
Primary Outcome 2 - Change From Baseline in Anxiety Symptoms Measured Using the Generalized Anxiety Disorder-7 (GAD-7)
Lasso di tempo: Baseline and approximately 3 months after baseline/completion of the intervention

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.

Baseline and approximately 3 months after baseline/completion of the intervention

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline in Psychological Well-Being Measured Using the World Health Organization-Five Well-Being Index (WHO-5)
Lasso di tempo: Baseline and approximately 3 months after baseline.

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.
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)
Lasso di tempo: Baseline and approximately 3 months after baseline.

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.

Baseline and approximately 3 months after baseline.
Change From Baseline in Electronic Health Literacy Measured Using the eHealth Literacy Scale (eHEALS)
Lasso di tempo: Baseline and approximately 3 months after baseline.

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.

Baseline and approximately 3 months after baseline.
Change From Baseline in Reproductive-Health Knowledge Measured Using the 12-Item Reproductive-Health Literacy/Knowledge Module
Lasso di tempo: Baseline and approximately 3 months after baseline.

Reproductive-health knowledge will be assessed using the study-specific 12-item Reproductive-Health Literacy/Knowledge 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.

Baseline and approximately 3 months after baseline.
Change From Baseline in Reproductive-Health Attitudes and Self-Efficacy Measured Using a 7-Item Study-Specific Questionnaire
Lasso di tempo: Baseline and approximately 3 months after baseline.

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.

Baseline and approximately 3 months after baseline.
Acceptability of the E-Clinic Measured Using the Acceptability of Intervention Measure (AIM)
Lasso di tempo: Approximately 3 months after baseline.

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.
Participant-Reported Usability of The E-Clinic
Lasso di tempo: Approximately 3 months after baseline.

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.

Approximately 3 months after baseline.
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
Lasso di tempo: Approximately 3 months after baseline.

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.

Approximately 3 months after baseline.
Number of Individual Psychosocial Consultation Sessions Completed
Lasso di tempo: From enrollment through approximately 3 months after baseline.

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.
Participation in Virtual Group or Peer-Support Sessions
Lasso di tempo: From enrollment through approximately 3 months after baseline.

Participants will report whether they used virtual group or peer-support sessions during the follow-up period (No/Yes). The number and percentage of participants reporting participation will be reported.

From enrollment through approximately 3 months after baseline.
Number of Educational Modules Completed and Used
Lasso di tempo: From enrollment through approximately 3 months after baseline.

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.

From enrollment through approximately 3 months after baseline.
Use of E-Clinic Self-Help Exercises or Activities
Lasso di tempo: From enrollment through approximately 3 months after baseline.

Participants will report whether they used e-clinic self-help exercises or activities during the follow-up period (No/Yes). The number and percentage of participants reporting use will be reported.

From enrollment through approximately 3 months after baseline.
Use of Referral Information or Referral Support
Lasso di tempo: From enrollment through approximately 3 months after baseline.

Participants will report whether they used referral information or referral support provided through the e-clinic during the follow-up period (No/Yes). The number and percentage of participants reporting use will be reported.

From enrollment through approximately 3 months after baseline.
Participant-Reported Relevance and Usefulness Measured Using the 4-Item Relevance and Usefulness Domain of the E-Clinic Implementation Research Questionnaire
Lasso di tempo: Approximately 3 months after baseline.

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.

Approximately 3 months after baseline.
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
Lasso di tempo: Approximately 3 months after baseline.

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.

Approximately 3 months after baseline.
Appropriateness of the E-Clinic Measured Using the Intervention Appropriateness Measure (IAM)
Lasso di tempo: Approximately 3 months after baseline.

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.

Approximately 3 months after baseline.
Feasibility of the E-Clinic Measured Using the Feasibility of Intervention Measure (FIM)
Lasso di tempo: Approximately 3 months after baseline.

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.

Approximately 3 months after baseline.
Receipt of an E-Clinic Referral Recommendation
Lasso di tempo: From enrollment through approximately 3 months after baseline.

Participants will report whether an e-clinic provider recommended that they seek additional support or referral during the follow-up period (No/Yes). The number and percentage of participants who received a referral recommendation will be reported.

From enrollment through approximately 3 months after baseline.
Referral Completion Status Among Participants Receiving an E-Clinic Referral Recommendation
Lasso di tempo: From enrollment through approximately 3 months after baseline.

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.

From enrollment through approximately 3 months after baseline.
Main Reported Barrier to Referral Completion Among Participants Who Did Not Complete a Recommended Referral
Lasso di tempo: From enrollment through approximately 3 months after baseline.

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.

From enrollment through approximately 3 months after baseline.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Mohammad S Alyahya, Jordan University of Science and Technology

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

29 agosto 2026

Completamento primario (Stimato)

1 settembre 2027

Completamento dello studio (Stimato)

1 settembre 2027

Date di iscrizione allo studio

Primo inviato

20 settembre 2026

Primo inviato che soddisfa i criteri di controllo qualità

1 ottobre 2026

Primo Inserito (Effettivo)

6 ottobre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

6 ottobre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

1 ottobre 2026

Ultimo verificato

1 ottobre 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • JUST 20250519
  • 110527 - 001 (Altro numero di sovvenzione/finanziamento: International Development Research Centre (IDRC)/Canada)
  • NOV 2025/188-18 (Altro identificatore: Jordan University of Science and Technology Institutional Review Board approval)
  • MOH/REC/2025/620 (Altro identificatore: Ministry of Health, Jordan, Research Ethics Committee approval)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

Individual participant data will not be made publicly available because the study involves sensitive mental health, psychosocial, reproductive health, and potentially violence- and self-harm-related information, including data from adolescent participants and vulnerable populations. Participant data will be maintained confidentially in accordance with the approved informed consent procedures and the requirements of the Jordan University of Science and Technology and Ministry of Health ethics approvals. Aggregate study findings will be disseminated through scientific publications and presentations.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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