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

2026. augusztus 25. frissítette: 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.

A tanulmány áttekintése

Állapot

Még nincs toborzás

Körülmények

Beavatkozás / kezelés

Részletes leírás

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.

Tanulmány típusa

Beavatkozó

Beiratkozás (Becsült)

1300

Fázis

  • Nem alkalmazható

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi kapcsolat

Tanulmányozza a kapcsolattartók biztonsági mentését

Tanulmányi helyek

  • Pakisztán
    • Sindh
      • Karachi, Sindh, Pakisztán, 75600
        • Pakistan Institute of Living and Learning
        • Kapcsolatba lépni:
        • Kapcsolatba lépni:

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

  • Gyermek
  • Felnőtt
  • Idősebb felnőtt

Egészséges önkénteseket fogad

Igen

Leírás

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

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

  • Elsődleges cél: Megelőzés
  • Kiosztás: Véletlenszerűsített
  • Beavatkozó modell: Tényező hozzárendelés
  • Maszkolás: Egyetlen

Fegyverek és beavatkozások

Résztvevő csoport / kar
Beavatkozás / kezelés
Kísérleti: 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.
Viselkedési: Partners in Parenting
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.
Kísérleti: 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
Viselkedési: Shamiri
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.
Nincs beavatkozás: 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.

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Short Mood and Feelings Questionnaire- SMFQ (Angold et al., 1995)
Időkeret: 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

Másodlagos eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Spence Children's Anxiety Scale- (SCAS) Adolescent-report (Spence, 1997):
Időkeret: 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):
Időkeret: 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):
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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):
Időkeret: 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):
Időkeret: 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

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

Pakistan Institute of Living and Learning

Együttműködők

Monash University

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Becsült)

2026. szeptember 7.

Elsődleges befejezés (Becsült)

2027. szeptember 30.

A tanulmány befejezése (Becsült)

2027. szeptember 30.

Tanulmányi regisztráció dátumai

Először benyújtva

2026. augusztus 25.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2026. augusztus 25.

Első közzététel (Tényleges)

2026. augusztus 27.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2026. augusztus 27.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2026. augusztus 25.

Utolsó ellenőrzés

2026. augusztus 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

Kulcsszavak

További vonatkozó MeSH feltételek

Egyéb vizsgálati azonosító számok

  • Partners in Parenting_Pakistan

Terv az egyéni résztvevői adatokhoz (IPD)

Tervezi megosztani az egyéni résztvevői adatokat (IPD)?

IGEN

IPD terv leírása

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

IPD megosztási időkeret

Once the trial results are published

IPD-megosztási hozzáférési feltételek

Requests should be made to Principal Investigator

Az IPD megosztását támogató információ típusa

  • STUDY_PROTOCOL

Gyógyszer- és eszközinformációk, tanulmányi dokumentumok

Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz

Nem

Egy amerikai FDA által szabályozott eszközterméket tanulmányoz

Nem

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