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Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents (PiP_ Pakistan)

2026年8月25日 更新者:Pakistan Institute of Living and Learning

Cultural Adaptation and Randomized Controlled Trial Evaluation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents

Depression and anxiety are common mental health problems among adolescents and can affect their relationships, education, physical health and everyday lives. In Pakistan, many adolescents experience emotional difficulties, but mental health problems are often overlooked. Stigma, limited awareness about mental health and difficulties accessing professional support can prevent young people and families from getting the help they need. Parents play an important role in supporting their adolescents' mental health. The way parents communicate with their children, set family rules, manage conflict, provide emotional support and encourage healthy habits can influence adolescents' wellbeing. However, parenting programmes that help parents reduce the risk of depression and anxiety in adolescents are limited in Pakistan. This study aims to address this gap by adapting and evaluating an online parenting programme called Partners in Parenting (PiP) for families in Pakistan. Hence, the aim is to find out whether the culturally adapted PiP programme can reduce the risk of depression and anxiety among adolescents and improve parenting practices and parent-adolescent relationships. We will also explore whether the programme is acceptable, easy to use and helpful for Pakistani families, and whether it provides good value for the resources required to deliver it. First, we will work with adolescents, parents, grandparents, teachers and health professionals to understand their experiences and views about adolescent mental health and parenting in Pakistan. Their feedback will be used to make PiP culturally appropriate and relevant to Pakistani families. People with lived experience of adolescent mental health difficulties will also be involved throughout the adaptation process. The study will then evaluate the adapted programme with 1,300 parent-adolescent pairs across eight cities in Pakistan: Karachi, Hyderabad, Lahore, Rawalpindi, Multan, Qambar Shahdad Kot, Larkana and Sukkur. Families will be randomly allocated to three groups i.e partners in parenting, Shamiri, and control group. PiP is an online programme designed to help parents develop positive parenting skills and strengthen their relationships with their adolescents. Adolescents participating in the study will receive a four-session programme called Shamiri, which focuses on developing a growth mindset, gratitude and personal values. Process evaluation will explore how the programme is delivered and experienced in real-world settings. This will help us understand whether families engage with and complete the programme, which parts they find useful or difficult, how acceptable and practical the intervention is, and what factors may support or prevent successful implementation. We will gather information from parents, adolescents and those involved in delivering or supporting the programme to understand their experiences and identify ways the programme could be improved and implemented more effectively. The findings could help identify practical and accessible ways to support adolescent mental health in Pakistan. The study will give parents and adolescents an opportunity to contribute to research that aims to improve mental health support for young people in Pakistan.

研究概览

详细说明

Research Aim: To test the preliminary efficacy of PiP intervention in reducing the risk of depression in adolescents at end of intervention (3-months) using the adolescent-report Short Mood and Feelings Questionnaire- SMFQ which assesses depressive symptoms in children and adolescents. Methods: Methods:

Work Package 1- Understanding local context to co-design PiP intervention. A qualitative approach will be used to conduct in-depth interviews with adolescents with lived experience of mental health difficulties, their parents and grandparents, health professionals (mental health experts/ family physicians) and teachers (15-20 participants/category) to explore the mental health difficulties experiences of adolescents, parenting and how stakeholders think parents should support adolescents to adapt PiP modules. The Lived Experience Experts (LEE) groups will be developed province wise who will be actively engaged in the adaptation process of the intervention. Work Package 2-Randomized Controlled Trial of culturally adapted PiP intervention compared to control arm. This is a three-arm, parallel group design RCT, comparing intervention to the control arm. Parents who have an adolescent aged 12-18 years, Have sufficient internet literacy, access, and/or ability to read and write, will be invited to participate. A total 1300 participants will be approached in schools, colleges and community settings in 8 cities in Pakistan: Karachi, Hyderabad, Lahore, Rawalpindi, Multan, Qamabar Shahdad Kot, Larkana, and Sukker. Work Package 3: Process evaluation underpinned by Interpretative phenomenological analysis. This WP involves semi-structured interviews (n=15/category) with adolescents and their parents from the intervention arm and research team to explore their experiences of engaging in the intervention and their views on its cultural appropriateness in empowering them to support adolescent mental health, reduce depression and anxiety amongst adolescents and improve parenting relationships. Only research team members directly involved in the implementation or delivery of the intervention will be eligible to participate in the semi-structured interviews.

研究类型

介入性

注册 (估计的)

1300

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

是的

描述

Inclusion Criteria

  1. Parents who have an adolescent aged 12-18 years. (If they have more than one child in this age bracket, only one child can participate that will be depend on their own willingness and mutual understanding).
  2. Have sufficient internet literacy, access, and/or ability to read and write.
  3. Only 1 parent-adolescent dyad/family will be eligible to participate, that will be depend on their own willingness and mutual understanding.

Exclusion Criteria

  1. Presence of a diagnosed severe psychiatric disorder (e.g., bipolar disorder or Schizophrenia) or a severe physical illness in either the parent or adolescent that would significantly impair their ability to participate meaningfully in the study procedures.
  2. Lack of capacity to provide informed consent (parent) or assent (adolescent), as determined by the trained research team.
  3. Families who are temporary residents in the study city

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:阶乘赋值
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Partners in Parenting
The Partners in Parenting (PiP) intervention is a fully automated, web-based parenting program. Nine modules are available in total, and parents can further tailor their program by selecting additional modules not initially recommended or opting out of recommended ones. Modules feature interactive activities, goal-setting exercises, audio clips, vignettes, illustrations, and an end-of-module quiz with immediate feedback to reinforce learning. Each module takes approximately 15-25 minutes to complete, with one module released weekly to allow time for completion and practice of weekly goals. Automated weekly emails notify parents when the next module is available via their personalized dashboard.
The Partners in Parenting (PiP) intervention is a fully automated, web-based parenting program comprising three components. First, parents complete a self-assessment scale, the Parenting to Reduce Adolescent Depression and Anxiety Scale (PRADAS), which evaluates their current parenting practices against established Guidelines. Second, based on PRADAS responses, parents receive an individually tailored feedback report highlighting their parenting strengths and areas for improvement. The feedback is designed to be concise, encourage behavior change, provide practical parenting strategies, and include links to additional resources if desired. Third, parents are recommended a series of interactive online modules, personalized according to their PRADAS responses. Nine modules are available in total, and parents can further tailor their program by selecting additional modules not initially recommended or opting out of recommended ones.
实验性的:Shamiri
The Shamiri intervention (from the Swahili word for "thrive") is an evidence-based, 4-week, group-based mental health program designed for adolescents to reduce depression and anxiety. This intervention is derived from the Growth Mindset Single Session Intervention (GM-SSI) which has demonstrated effectiveness for a range of psychological problems of adolescents, including depression and anxiety
group-based mental health program designed for adolescents to reduce depression and anxiety. This intervention is derived from the Growth Mindset Single Session Intervention (GM-SSI) which has demonstrated effectiveness for a range of psychological problems of adolescents, including depression and anxiety, as well as other distress-related difficulties. Evidence indicates that GM-SSI can serve as a low-cost approach to enhance youth resilience and mental health. The shamiri is mindset program comprising: a growth mindset module (2 sessions), a gratitude module (1 session), and a values affirmation module (1 session). Sessions are delivered weekly, each lasting approximately one hour.
无干预:Control
Parents and adolescents in the control group will be assessed at baseline and 3rd month outcome assessment. To ensure equitable access to intervention materials for participants in the control group, they will have access to these materials after the follow-up assessments are completed.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Short Mood and Feelings Questionnaire- SMFQ (Angold et al., 1995)
大体时间:Baseline and 3 months
The SMFQ, Adolescent-reported, consists of a series of 13 descriptive phrases regarding how the subject has been feeling or acting recently. It is a screening tool for depression in children and young people aged 6 to 19. A total score on the child version of the SMFQ of 8 or more is considered significant.
Baseline and 3 months

次要结果测量

结果测量
措施说明
大体时间
Spence Children's Anxiety Scale- (SCAS) Adolescent-report (Spence, 1997):
大体时间:Baseline and 3 months Follow up
The Spence Children's Anxiety Scale is developed to assess the severity of anxiety symptoms broadly in line with the dimensions of anxiety disorder proposed by the DSM-IV. The scale assesses six domains of anxiety including generalized anxiety, panic/agoraphobia, social phobia, separation anxiety, obsessive compulsive disorder and physical injury fears. The scale normally takes around 10 minutes to answer the questions. Each symptom is rated using a four-point frequency scale indicating how often it is experienced.
Baseline and 3 months Follow up
Parenting to Reduce Adolescent Depression and Anxiety Scale (PRADAS) (Cardamone-Breen, Jorm, Lawrence, Mackinnon, & Yap, 2017):
大体时间:Baseline and 3 months
PRADAS is designed to assess the change in parenting risk and protective factors to reduce risk of depression and anxiety in adolescents. PRADA assess parenting practices in concordance with the nine domains of PiP current parenting practices against specific recommendations in the Guidelines. Items are assessed using Likert-type scales and scored as either concordant (1) or non-concordant (0) with the Guidelines' recommendations. The total score therefore ranges from 0 to 43, with higher scores indicating greater concordance. Both Adolescent and parent-report assessment will be completed.
Baseline and 3 months
The McMaster Family Assessment Device-General Functioning subscale (FAD-GF) (Epstein, Baldwin, & Bishop, 1983):
大体时间:Baseline and 3 months
The FAD-GF is a brief self-report measure derived from the 60-item Family Assessment Device and can be completed by family members aged 12 years and older with responses rated on a 4-point Likert scale from strongly agree to strongly disagree. It consists of 12 items assessing overall family functioning, with six positively worded and six negatively worded items, and has been shown to correlate strongly with most FAD subscales, supporting its use as a valid proxy for the full instrument. The FAD will be administered to both adolescents and parent.
Baseline and 3 months
EuroQol 5 Dimensions (Brooks & Group, 2017)
大体时间:Baseline and 3 months
Health-related quality of life will be assessed using the EQ-5D by exploring 5 areas: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension is rated using the following categories: no problems, slight problems, moderate problems, severe problems, and extreme problems. In addition, a visual analogue scale (VAS) is included to record the patient's self-rated health. This scale has been used in previous trials in Pakistan (Alvi et al., 2022; Husain et al., 2021). The ED 5D will be administered to adolescent.
Baseline and 3 months
Client Service Receipt Inventory (CSRI) (Beecham & Knapp, 2001)
大体时间:Baselines and 3 months
Information on participants' use of both formal and informal (such as Imams/faith healers) health services was collected at baseline and follow-up assessments using a structured form. The healthcare costs, including staffing, equipment, training, delivering and monitoring, as well as patient-level direct and indirect costs will be collected using the bespoke tool (Alvi et al., 2022). The CSRI will be administered to adolescent.
Baselines and 3 months
Short Mood and Feelings Questionnaire (SMFQ) - (Angold et al., 1995)
大体时间:Baseline and 3 months
The Mood and Feelings Questionnaire (Short Version) - Parent Report (SMFQ-Parent) is a 13-item measure assessing recent depressive symptomatology in children and adolescents. The SMFQ-Parent consists of items scored 0 (not true), 1 (sometimes), or 2 (true), reflecting the frequency of depressive symptoms observed in the child over the past two weeks. The sum of responses to all items produces a total score ranging from 0 to 26. Higher scores indicate greater severity of depressive symptoms.
Baseline and 3 months
The Spence Children's Anxiety Scale - Parent Version (SCAS-Parent) (Nauta et al., 2004):
大体时间:Baseline and 3 months
SCAS-Parent is a 39-item parent report measure designed to assess anxiety symptoms in children and adolescents across six domains of anxiety (details are provided in SCAS- Adolescents report).
Baseline and 3 months
System Usability Scale (SUS) (Bangor, Kortum, & Miller, 2008):
大体时间:Baseline and 3 months
Usability of the interventions will be measured with SUS. The SUS is composed of 10 statements that are scored on a 5-point scale of extent of agreement (score 0 to 100). The reliability is good (α=0.91). Interventions with scores of 70 and above are accepted as highly usable and scores between 50 and 70 indicate acceptable usability of an intervention. Interventions with scores 50 and below are subject to concerns about their usability by the target population. The SUS will be administered to parents.
Baseline and 3 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月7日

初级完成 (估计的)

2027年9月30日

研究完成 (估计的)

2027年9月30日

研究注册日期

首次提交

2026年8月25日

首先提交符合 QC 标准的

2026年8月25日

首次发布 (实际的)

2026年8月27日

研究记录更新

最后更新发布 (实际的)

2026年8月27日

上次提交的符合 QC 标准的更新

2026年8月25日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • Partners in Parenting_Pakistan

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

Only anonymized data will be shared. Requests to be made to Principal Investigator

IPD 共享时间框架

Once the trial results are published

IPD 共享访问标准

Requests should be made to Principal Investigator

IPD 共享支持信息类型

  • 研究方案

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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