Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents (PiP_ Pakistan)
25 août 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
1300
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Rabia Sattar, PhD (Scholar)
- Numéro de téléphone: +923332976807
- E-mail: rabia.sattar@pill.org.pk
Sauvegarde des contacts de l'étude
- Nom: Nasim Chaudhry, MD
- Numéro de téléphone: +923160129255
- E-mail: nasim.chaudhry@pill.org.pk
Lieux d'étude
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Sindh
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Karachi, Sindh, Pakistan, 75600
- Pakistan Institute of Living and Learning
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Contact:
- Nasim Chaudhry, MD
- Numéro de téléphone: 0922135371084
- E-mail: nasim.chaudhry@pill.org.pk
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Contact:
- Rabia Sattar, PhD Scholar
- Numéro de téléphone: +92 3332976807
- E-mail: rabia.sattar@pill.org.pk
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Oui
La description
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation factorielle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 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.
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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.
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Expérimental: 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
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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.
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Aucune intervention: 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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Short Mood and Feelings Questionnaire- SMFQ (Angold et al., 1995)
Délai: Baseline and 3 months
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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.
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Baseline and 3 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Spence Children's Anxiety Scale- (SCAS) Adolescent-report (Spence, 1997):
Délai: Baseline and 3 months Follow up
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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.
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Baseline and 3 months Follow up
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Parenting to Reduce Adolescent Depression and Anxiety Scale (PRADAS) (Cardamone-Breen, Jorm, Lawrence, Mackinnon, & Yap, 2017):
Délai: Baseline and 3 months
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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.
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Baseline and 3 months
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The McMaster Family Assessment Device-General Functioning subscale (FAD-GF) (Epstein, Baldwin, & Bishop, 1983):
Délai: Baseline and 3 months
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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.
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Baseline and 3 months
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EuroQol 5 Dimensions (Brooks & Group, 2017)
Délai: Baseline and 3 months
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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.
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Baseline and 3 months
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Client Service Receipt Inventory (CSRI) (Beecham & Knapp, 2001)
Délai: Baselines and 3 months
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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.
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Baselines and 3 months
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Short Mood and Feelings Questionnaire (SMFQ) - (Angold et al., 1995)
Délai: Baseline and 3 months
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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.
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Baseline and 3 months
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The Spence Children's Anxiety Scale - Parent Version (SCAS-Parent) (Nauta et al., 2004):
Délai: Baseline and 3 months
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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).
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Baseline and 3 months
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System Usability Scale (SUS) (Bangor, Kortum, & Miller, 2008):
Délai: Baseline and 3 months
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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.
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Baseline and 3 months
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Collaborateurs
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
7 septembre 2026
Achèvement primaire (Estimé)
30 septembre 2027
Achèvement de l'étude (Estimé)
30 septembre 2027
Dates d'inscription aux études
Première soumission
25 août 2026
Première soumission répondant aux critères de contrôle qualité
25 août 2026
Première publication (Réel)
27 août 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
27 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
25 août 2026
Dernière vérification
1 août 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Partners in Parenting_Pakistan
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
Only anonymized data will be shared.
Requests to be made to Principal Investigator
Délai de partage IPD
Once the trial results are published
Critères d'accès au partage IPD
Requests should be made to Principal Investigator
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .