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Risk of Depression and AnxietyPiP_ PakistanNCT07790835

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

A study testing Partners in Parenting in people with Risk of Depression and Anxiety, run by Pakistan Institute of Living and Learning at 1 site in Pakistan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Risk of Depression and Anxiety
What is being tested?
Partners in Parenting
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,300 participants
Where
1 sitePakistan
Study dates
26 Oct 2026to 30 Sep 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Rabia Sattar, PhD (Scholar) contact

+923332976807

rabia.sattar@pill.org.pk

Nasim Chaudhry, MD contact

+923160129255

nasim.chaudhry@pill.org.pk

Pakistan1 site, 1 recruiting
  • Pakistan Institute of Living and Learning

    Karachi, Sindh, 75600

    Nasim Chaudhry, MD, 0922135371084, nasim.chaudhry@pill.org.pk

    Rabia Sattar, PhD Scholar, +92 3332976807, rabia.sattar@pill.org.pk

    Recruiting

Other trials in Pakistan

About this study

Official title: 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. 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.

Being tested
Partners in Parenting, Shamiri
Keywords
Adolescents, Parenting, depression, anxiety, Pakistan
Medical subject headings
Anxiety Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Partners in ParentingBehavioural

    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.

  • ShamiriBehavioural

    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.

Study groups in NCT07790835
Study groupRoleWhat they receive
Partners in ParentingExperimentalThe 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.
Receives: Behavioral: Partners in Parenting
ShamiriExperimentalThe 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
Receives: Behavioral: Shamiri
ControlNo interventionParents 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline and 3 months

Secondary outcomes (8)
  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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).

    Measured: 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.

    Measured: Baseline and 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2026
  2. Study start26 Oct 2026
  3. Primary completion30 Sep 2027 (estimated)
  4. Study completion30 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07790835
Sponsor's protocol ID
Partners in Parenting_Pakistan
Acronym
PiP_ Pakistan
Status last verified
Oct 2026
First submitted
25 Aug 2026
Last updated
6 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Only anonymized data will be shared. Requests to be made to Principal Investigator

Questions about this trial

What is this clinical trial studying?

A study testing Partners in Parenting in people with Risk of Depression and Anxiety, run by Pakistan Institute of Living and Learning at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Rabia Sattar, PhD (Scholar) (+923332976807, rabia.sattar@pill.org.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Short Mood and Feelings Questionnaire- SMFQ (Angold et al., 1995) (time frame: Baseline and 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.

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