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| Name | Class |
|---|---|
| UNODC | UNKNOWN |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Strong Families Programme Intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From baseline to end of intervention at 3 weeks (post randomisation) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At baseline, week 5 and week 9 of post baseline |
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Inclusion Criteria:
Exclusion Criteria:
Respecting the cultural context, either males or females' caregivers can be engaged at one time in our study setting. As females are most often the primary caregivers in Pakistan, female primary caregivers and their children (of either gender) will be invited to participate in this study.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| MUQADDAS ASIF | Contact | 03364057787 | muqaddasasif@pill.org.pk |
| Name | Affiliation | Role |
|---|---|---|
| Salman Shahzad | Pakistan Institute of Living and Learning | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Community setting | Recruiting | Karachi | 75600 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38951006 | Derived | 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. |
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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.
After 2 years of trial completion.
The data could be requested from the corresponding author with a reasonable request.
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| ID | Term |
|---|---|
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
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| 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. |
| 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. | At baseline, week 5 and week 9 of post baseline |