- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07790835
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents (PiP_ Pakistan)
Cultural Adaptation and Randomized Controlled Trial Evaluation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Rabia Sattar, PhD (Scholar)
- Phone Number: +923332976807
- Email: rabia.sattar@pill.org.pk
Study Contact Backup
- Name: Nasim Chaudhry, MD
- Phone Number: +923160129255
- Email: nasim.chaudhry@pill.org.pk
Study Locations
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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
- Phone Number: 0922135371084
- Email: nasim.chaudhry@pill.org.pk
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Contact:
- Rabia Sattar, PhD Scholar
- Phone Number: +92 3332976807
- Email: rabia.sattar@pill.org.pk
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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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.
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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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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
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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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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Short Mood and Feelings Questionnaire- SMFQ (Angold et al., 1995)
Time Frame: 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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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Spence Children's Anxiety Scale- (SCAS) Adolescent-report (Spence, 1997):
Time Frame: 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):
Time Frame: 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):
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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):
Time Frame: 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):
Time Frame: 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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Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Partners in Parenting_Pakistan
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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