Mental HealthNCT05933850
Culturally Adapted Strong Families Programme for Families Living in Gilgit Baltistan, Pakistan
A study testing Strong Families Programme Intervention in people with Mental Health, run by Pakistan Institute of Living and Learning at 1 site in Pakistan.
Trial summary
The aim of this exploratory study is to test the Strong Family (SF) programme in improving family functioning. Participants will be randomized to one of the two study arms 1)- Intervention group in which participants will receive 3 group sessions of SF programme (8-12 families per group) 2)- Control group (control… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mental Health
- What is being tested?
- Strong Families Programme Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2026to 31 Mar 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female primary caregiver to a child aged between 8-15 years
- Able to speak and understand Urdu language
- Capable to give informed consent
Who cannot join
- Families that had already taken part in another family skills training programme in the past 6 months or where the caregiver lived separately from the child
- Not the primary caregiver of the child
- Unlikely to be available for the duration of the whole study and outcome assessments (e.g., temporary residence).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Community setting
Karachi, 75600
Asif Community setting, 02135871845, muhammad.asif@pill.org.pk
About this study
Official title: Culturally Adapted Strong Families Programme to Improve Child Behavior and Family Functioning in Families Living in Gilgit Baltistan, Pakistan
The aim of this exploratory study is to test the Strong Family (SF) programme in improving family functioning. Participants will be randomized to one of the two study arms 1)- Intervention group in which participants will receive 3 group sessions of SF programme (8-12 families per group) 2)- Control group (control group will be in the waiting list and receive SF training sessions once the study will be completed).
Read the detailed description
This will be multicentre feasibility randomised controlled trial to test the effectiveness of the SF programme in improving family skills outcomes and caregiver and child mental health, as reported by caregivers when implemented in Gilgit-Baltistan. The study will record families' rates of recruitment and attendance to SF programme, evaluate the completeness of programme delivery, cultural acceptability through qualitative interviews and assess the fidelity of training delivery. A small pilot study with N=10 families (a female caregiver (mother) and one child between the age of 8-15 years from each family) will be conducted before main RCT. The study will be conducted in three sites including Karachi, Lahore and Gilgit Baltistan, Pakistan. We will interview a subset of participants i.e. up to 5 caregivers from each study site (N=15 caregivers) to explore participants' opinions on the acceptability of the programme and to explore any barriers or facilitators to participation.
- Conditions
- Mental Health
- Being tested
- Strong Families Programme Intervention
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strong Families Programme InterventionBehavioural
This is a family skills programme providing an evidence-informed prevention to support caregivers to be better parents and strengthen positive age-specific and age-appropriate family functioning and interactions to help prevent drug use, violence and other negative social consequences in their children.
| Study group | Role | What they receive |
|---|---|---|
| Strong Family Programme Intervention | Experimental | There will be 3 weekly group sessions of the strong family programme with caregivers and children (8-12 families per group). Receives: Behavioral: Strong Families Programme Intervention |
| Waitlist control group | Active comparator | This group will be on the waiting list and receive SF programme training sessions once the study will be completed. Receives: Behavioral: Strong Families Programme Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility and acceptability indicators
We will record feasibility indicators in terms of families' rates of recruitment and attendance to programme, and programme completeness. To evaluate cultural acceptability of programme by families, interviews with caregivers will be conducted to explore family members' opinions on the acceptability of the programme, any barriers or facilitators to participation.
Measured: From baseline to end of intervention at 3 weeks (post randomisation)
Secondary outcomes (3)
Strengths and Difficulties Questionnaire
The Strengths and Difficulties Questionnaire is a brief behavioural screening questionnaire and ask about 25 attributes, some positive and others negative. This will be administered to both child and the caregiver.
Measured: At baseline, week 5 and week 9 of post baseline
Parenting and Family Adjustment Scale
This will measures parenting practices and parental adjustment. This scale has been developed to be used in low resource settings.
Measured: At baseline, week 5 and week 9 of post baseline
Child and Youth Resilience Measure
This is a screening tool to explore the resources available that may bolster resilience.
Measured: At baseline, week 5 and week 9 of post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start1 Mar 2026
- Primary completion30 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Living and Learning
- Sponsor type
- University, hospital or other
- Collaborators
- UNODC
- Responsible party
- Sponsor
- Investigators
- Salman Shahzad, Principal investigator, Pakistan Institute of Living and Learning
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05933850
- Sponsor's protocol ID
- PILL-SFP-GB-001
- Status last verified
- May 2026
- First submitted
- 25 May 2023
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) will be shared with other researchers, encompassing essential information such as demographic details, primary and secondary outcome measures, intervention exposure metrics, and process evaluation data. Rigorous measures will be implemented to ensure the complete de-identification of the data and safeguard the anonymity of individual participants.
Publications
El-Khani A, Asif M, Shahzad S, Bux MS, Maalouf W, Rafiq NUZ, Khoso AB, Chaudhry IB, Van Hout MC, Zadeh Z, Tahir A, Memon R, Chaudhry N, Husain N. Assessing the efficacy of a brief universal family skills programme on child behaviour and family functioning in Gilgit-Baltistan, Pakistan: protocol for a feasibility randomised controlled trial of the Strong Families programme. BMJ Open. 2024 Jul 1;14(6):e081557. doi: 10.1136/bmjopen-2023-081557.
PubMed 38951006
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Culturally Adapted Strong Families Programme to Improve Child Behavior and Family Functioning in Families Living in Gilgit Baltistan, Pakistan
- ClinicalTrials.gov ID
- NCT05933850
- Acronym / sponsor ID
- PILL-SFP-GB-001
- Conditions
- Mental Health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Pakistan Institute of Living and LearningUniversity, hospital or other
- Collaborators
- UNODC
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 6 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this exploratory study is to test the Strong Family (SF) programme in improving family functioning. Participants will be randomized to one of the two study arms 1)- Intervention group in which participants will receive 3 group sessions of SF programme (8-12 families per group) 2)- Control group (control group will be in the waiting list and receive SF training sessions once the study will be completed).
Detailed description
This will be multicentre feasibility randomised controlled trial to test the effectiveness of the SF programme in improving family skills outcomes and caregiver and child mental health, as reported by caregivers when implemented in Gilgit-Baltistan. The study will record families' rates of recruitment and attendance to SF programme, evaluate the completeness of programme delivery, cultural acceptability through qualitative interviews and assess the fidelity of training delivery. A small pilot study with N=10 families (a female caregiver (mother) and one child between the age of 8-15 years from each family) will be conducted before main RCT. The study will be conducted in three sites including Karachi, Lahore and Gilgit Baltistan, Pakistan. We will interview a subset of participants i.e. up to 5 caregivers from each study site (N=15 caregivers) to explore participants' opinions on the acceptability of the programme and to explore any barriers or facilitators to participation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strong Family Programme Intervention | Experimental | Behavioral: Strong Families Programme InterventionThere will be 3 weekly group sessions of the strong family programme with caregivers and children (8-12 families per group). |
| Waitlist control group | Active comparator | Behavioral: Strong Families Programme InterventionThis group will be on the waiting list and receive SF programme training sessions once the study will be completed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female primary caregiver to a child aged between 8-15 years
- Able to speak and understand Urdu language
- Capable to give informed consent
Key exclusion criteria (3 listed)
- Families that had already taken part in another family skills training programme in the past 6 months or where the caregiver lived separately from the child
- Not the primary caregiver of the child
- Unlikely to be available for the duration of the whole study and outcome assessments (e.g., temporary residence).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Strong Families Programme InterventionThis is a family skills programme providing an evidence-informed prevention to support caregivers to be better parents and strengthen positive age-specific and age-appropriate family functioning and interactions to help prevent drug use, violence and other negative social consequences in their children. | Behavioural | Strong Family Programme Intervention, Waitlist control group |
Primary outcome
Feasibility and acceptability indicators
Time frame: From baseline to end of intervention at 3 weeks (post randomisation)
We will record feasibility indicators in terms of families' rates of recruitment and attendance to programme, and programme completeness. To evaluate cultural acceptability of programme by families, interviews with caregivers will be conducted to explore family members' opinions on the acceptability of the programme, any barriers or facilitators to participation.
3 secondary outcomes
Strengths and Difficulties Questionnaire
Time frame: At baseline, week 5 and week 9 of post baseline
Parenting and Family Adjustment Scale
Time frame: At baseline, week 5 and week 9 of post baseline
Child and Youth Resilience Measure
Time frame: At baseline, week 5 and week 9 of post baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Derived from this study: PubMed 38951006El-Khani A, Asif M, Shahzad S, Bux MS, Maalouf W, Rafiq NUZ, Khoso AB, Chaudhry IB, Van Hout MC, Zadeh Z, Tahir A, Memon R, Chaudhry N, Husain N. Assessing the efficacy of a brief universal family skills programme on child behaviour and family functioning in Gilgit-Baltistan, Pakistan: protocol for a feasibility randomised controlled trial of the Strong Families programme. BMJ Open. 2024 Jul 1;14(6):e081557. doi: 10.1136/bmjopen-2023-081557.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) will be shared with other researchers, encompassing essential information such as demographic details, primary and secondary outcome measures, intervention exposure metrics, and process evaluation data. Rigorous measures will be implemented to ensure the complete de-identification of the data and safeguard the anonymity of individual participants.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Salman Shahzad principal investigator
Pakistan Institute of Living and Learning
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strong Families Programme Intervention in people with Mental Health, 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 27 May 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 MUQADDAS ASIF (03364057787, muqaddasasif@pill.org.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and acceptability indicators (time frame: From baseline to end of intervention at 3 weeks (post randomisation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05933850, which also lists 1 linked publication.
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 27 May 2026.