ClinicalTrials.gg
RecruitingNCT07790835PiP_ PakistanUpdated Nov 6, 2026

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

An interventional study of Partners in Parenting and Shamiri in Risk of Depression and Anxiety, sponsored by Pakistan Institute of Living and Learning. Recruiting at 1 site in Pakistan. Per ClinicalTrials.gov, last updated 2026-11-06.

Primary conditionDepressionRegistry: Anxiety DisordersReclassifiedWhy we changed it
Registry
Anxiety Disorders — the first condition term the registry derived for this study.
ClinicalTrials.gg
Depression
Why
  1. The registry often attaches Anxiety Disorders to studies about something else, and this study's title and listed conditions do not name it.
  2. The study's listed conditions name Depression.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Pakistan Institute of Living and Learning · Not applicable, Interventional, and Prevention

Updated Nov 6, 2026Now RecruitingSite recruiting status changed+1 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
1,300
Allocation
Randomized
Sex
All
01

Study summary

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. The study will also assess the acceptability, usability and perceived benefits of the programme for Pakistani families, as well as its cost-effectiveness in relation to the resources required for implementation. The initial phase will involve exploring the experiences and perspectives of adolescents, parents, grandparents, teachers and health professionals regarding adolescent mental health and parenting practices 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. Information will be gathered from parents, adolescents and individuals involved in delivering or supporting the programme to explore their experiences and identify opportunities to refine the programme and enhance its implementation. 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.

Read the detailed description

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.

02

Conditions studied

  • Risk of Depression and Anxiety

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Keywords

  • Adolescents, Parenting, depression, anxiety, Pakistan
03

In context

Depression Reclassified

8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.

This study's planned enrollment of 1,300 is above the median of 81 across 7,063 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Pakistan Institute of Living and Learning is the lead sponsor of 59 studies on the registry; 17 are open to participants now.

Compared within Depression, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Anxiety Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 (parent) or assent (adolescent), as determined by the trained research team.
  3. Families who are temporary residents in the study city
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Single (Outcomes assessor)
Enrollment
1,300 participants (estimated)

Study arms

  • Experimental
    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.

    Behavioral: Partners in Parenting

  • Experimental
    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

    Behavioral: Shamiri

  • No 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.

Interventions

  • BehavioralPartners 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.

  • BehavioralShamiri

    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.

06

What researchers measure

Primary outcomes

  1. Short Mood and Feelings Questionnaire- SMFQ (Angold et al., 1995)

    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.

    Time frame: Baseline and 3 months

Secondary outcomes

  1. Spence Children's Anxiety Scale- (SCAS) Adolescent-report (Spence, 1997):

    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.

    Time frame: Baseline and 3 months Follow up

  2. Parenting to Reduce Adolescent Depression and Anxiety Scale (PRADAS) (Cardamone-Breen, Jorm, Lawrence, Mackinnon, & Yap, 2017):

    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.

    Time frame: Baseline and 3 months

  3. The McMaster Family Assessment Device-General Functioning subscale (FAD-GF) (Epstein, Baldwin, & Bishop, 1983):

    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.

    Time frame: Baseline and 3 months

  4. EuroQol 5 Dimensions (Brooks & Group, 2017)

    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.

    Time frame: Baseline and 3 months

  5. Client Service Receipt Inventory (CSRI) (Beecham & Knapp, 2001)

    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.

    Time frame: Baselines and 3 months

  6. Short Mood and Feelings Questionnaire (SMFQ) - (Angold et al., 1995)

    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.

    Time frame: Baseline and 3 months

  7. The Spence Children's Anxiety Scale - Parent Version (SCAS-Parent) (Nauta et al., 2004):

    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).

    Time frame: Baseline and 3 months

  8. System Usability Scale (SUS) (Bangor, Kortum, & Miller, 2008):

    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.

    Time frame: Baseline and 3 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — Only anonymized data will be shared. Requests to be made to Principal Investigator

Supporting information: Study protocol

Time frame: Once the trial results are published

Access criteria: Requests should be made to Principal Investigator

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Status
Not yet recruiting→Recruiting
changed Nov 6, 2026
Sites
Pakistan Institute of Living and Learning is now Recruiting
Nov 6, 2026
Start date
Sep 7, 2026→Oct 26, 2026 (actual)
Nov 6, 2026
Show all 1 update
  1. Nov 6, 2026
    Not yet recruiting→Recruiting
    Pakistan Institute of Living and Learning is now Recruiting
    Start date Sep 7, 2026→Oct 26, 2026 (now actual)
    + 2 other changes: verification date and description

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07790835
Lead sponsor
Pakistan Institute of Living and Learning
Collaborators
Monash University
Responsible party
Sponsor
First posted
Aug 27, 2026
Start date
Oct 26, 2026
Primary completion
Sep 30, 2027 (estimated)
Completion
Sep 30, 2027 (estimated)
Last update
Nov 6, 2026

Study contacts

Rabia Sattar, PhD (Scholar)
Contact
rabia.sattar@pill.org.pk
+923332976807
Nasim Chaudhry, MD
Contact
nasim.chaudhry@pill.org.pk
+923160129255

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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