Cultural Adaptation and Randomized Controlled Trial Evaluation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,300
- 试验地点
- 1
- 主要终点
- Short Mood and Feelings Questionnaire- SMFQ (Angold et al., 1995)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
- •Have sufficient internet literacy, access, and/or ability to read and write.
- •Only 1 parent-adolescent dyad/family will be eligible to participate, that will be depend on their own willingness and mutual understanding.
排除标准
- •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.
- •Lack of capacity to provide informed consent (parent) or assent (adolescent), as determined by the trained research team.
- •Families who are temporary residents in the study city
结局指标
主要结局
Short Mood and Feelings Questionnaire- SMFQ (Angold et al., 1995)
时间窗: 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.
次要结局
- Spence Children's Anxiety Scale- (SCAS) Adolescent-report (Spence, 1997):(Baseline and 3 months Follow up)
- Parenting to Reduce Adolescent Depression and Anxiety Scale (PRADAS) (Cardamone-Breen, Jorm, Lawrence, Mackinnon, & Yap, 2017):(Baseline and 3 months)
- The McMaster Family Assessment Device-General Functioning subscale (FAD-GF) (Epstein, Baldwin, & Bishop, 1983):(Baseline and 3 months)
- EuroQol 5 Dimensions (Brooks & Group, 2017)(Baseline and 3 months)
- Client Service Receipt Inventory (CSRI) (Beecham & Knapp, 2001)(Baselines and 3 months)
- Short Mood and Feelings Questionnaire (SMFQ) - (Angold et al., 1995)(Baseline and 3 months)
- The Spence Children's Anxiety Scale - Parent Version (SCAS-Parent) (Nauta et al., 2004):(Baseline and 3 months)
- System Usability Scale (SUS) (Bangor, Kortum, & Miller, 2008):(Baseline and 3 months)