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

2026年10月1日 更新者: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.

調査の概要

詳細な説明

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

研究の種類

介入

入学 (推定)

250

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

      • Irbid、ヨルダン、22110
        • 募集
        • Jordan University of Science and Technology
        • コンタクト:

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

14年~65年 (子、大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

女性

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:ヘルスサービス研究
  • 割り当て:なし
  • 介入モデル:単一グループの割り当て
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
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)
時間枠: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)
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
Change From Baseline in Psychological Well-Being Measured Using the World Health Organization-Five Well-Being Index (WHO-5)
時間枠: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)
時間枠: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)
時間枠: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
時間枠: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
時間枠: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)
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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)
時間枠: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)
時間枠: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
時間枠: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
時間枠: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
時間枠: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.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • 主任研究者:Mohammad S Alyahya、Jordan University of Science and Technology

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年8月29日

一次修了 (推定)

2027年9月1日

研究の完了 (推定)

2027年9月1日

試験登録日

最初に提出

2026年9月20日

QC基準を満たした最初の提出物

2026年10月1日

最初の投稿 (実際)

2026年10月6日

学習記録の更新

投稿された最後の更新 (実際)

2026年10月6日

QC基準を満たした最後の更新が送信されました

2026年10月1日

最終確認日

2026年10月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • JUST 20250519
  • 110527 - 001 (その他の助成金/資金番号:International Development Research Centre (IDRC)/Canada)
  • NOV 2025/188-18 (その他の識別子:Jordan University of Science and Technology Institutional Review Board approval)
  • MOH/REC/2025/620 (その他の識別子:Ministry of Health, Jordan, Research Ethics Committee approval)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

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.

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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