Assessing the Feasibility of Providing a Family Skills Intervention "Strong Families" for Families in the Philippines.

NCT05948787 | Unknown DMC

• 2 other identifiers: UNODC POPHL 2023INL US State Department
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 5

Brief Summary

The Strong Families Programme was introduced by UNODC in the Philippines in 2018 through the training of facilitators. Twenty-six participants trained in the program from different cities and municipalities. Afterward, Caloocan, Marikina, Palawan, Pasig, and Quezon City Local Government Units (LGUs) started to train more facilitators to allow them to pilot the program in their communities. Eventually, these cities and municipalities managed to engage families to benefit from the Strong Families Programme. The current study aims to explore the feasibility, effectiveness and acceptability of this universal prevention program with families in the Philippines, and the feasibility of delivering the program. The primary objective will be to test the effectiveness of the Strong Families program in improving family skills outcomes and caregiver and child mental health, as reported by caregivers, when implemented in the Philippines. The secondary objective will be to calculate the extent of family's attendance of Strong Families sessions, to evaluate completeness of program delivery. The tertiary objective will be to explore the cultural and contextual acceptability of the Strong Families program for families in the Philippines. A two-arm feasibility Randomized Controlled Trial with two arms: 1) Implementation of Strong Families (Intervention Group) and 2) Wait list/Control (Services-as-usual). This trial will have an embedded process evaluation. This study will take place in five locations in the Philippines. The implementation usually happens at the Barangay Level (The smallest administrative division in the Philippines and is the native Filipino term for a village, district, or ward)

Conditions

Parenting Skills; Family Relationship

Keywords

communication; bonding

Outcome Measures

Primary Outcomes (1)

• Improved parenting skills

  Improved caregiver confidence in family management skills Improved caregiving in parenting skills Improved child behaviour Reduced aggressive and hostile behaviours Increased capacity to cope with stress Improved mental health outcomes in children and parents

  three data time frames: 2 weeks post intervention, 3 weeks post intervention, and 6 weeks post intervention

Study Arms (2)

Intervention Group

OTHER

Intervention group' Families take part in weekly sessions of Strong Families for 3 weeks. All family's complete measures again (Time 2, two weeks post intervention). All family's complete measures again (Time 3, 6 weeks post intervention)

Behavioral: Psychosocial intervention

Waitlist group' Families take part in weekly sessions of Strong Families after the data measures

EXPERIMENTAL

Families in the RCT will be randomized to implementation of the Intervention or Waitlist group . Families will be allocated using online software (www.sealedenvelope.com). We are aware that randomization before recruiting participants can influence recruitment and dropout in the control arm. To minimize these issues, we have included costs for compensating families for participation in study measure completion and will instruct staff not to reveal family allocation until families have agreed to take part and before signing informed consent. This is an un-blinded trial. Research assistants, staff and families will be aware of participants' allocated condition during the trial.

Behavioral: Psychosocial intervention

Interventions

Psychosocial intervention BEHAVIORAL

A structured sessions for families that promotes improving communication, bonding, and improved parenting techniques in managing stress within the family setting.

Also known as: Group sessions

Intervention Group; Waitlist group' Families take part in weekly sessions of Strong Families after the data measures

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Parent or caregivers that speak Filipino (Tagalog) with at least one child and up to two children under their care aged 8-14
• Willing to take part in the program
• Will be in town for the duration of the programme and research sessions

You may not qualify if:

• Families that have taken part in family skills training in the past 24 months
• Families in which parent/caregiver live separately from children
• Families in which parents/caregivers/children identified to have drug dependence

Sponsors & Collaborators

• United Nations Office on Drugs and Crime (UNODC): lead
• Polytechnique University of the Philippines: collaborator
• Anti-Drug Abuse Councils, LGUs in the Philippines: collaborator

Study Sites (5)

Caloocan Anti-drug Abuse Council

Caloocan, 1421, Philippines

Location

Ministry of Social Services Department

Cotabato City, 9600, Philippines

Location

Marikina Anti-drug Abuse Council

Marikina City, 1811, Philippines

Location

Anti-drug Abuse Council Office of Pasig

Pasig, 1609, Philippines

Location

Quezon City Anti-drug Abuse Council

Quezon City, 1800, Philippines

Location

Related Publications (4)

• 1 Prevention, Treatment and Rehabilitation Section, Drug Prevention and Health Branch, United Nations Office on Drugs and Crime (UNODC), Division of Operations, Wagramer Strasse 5, A-1400 Vienna, Austria; karin.haar@un.org (K.H.); wadih.maalouf@un.org (W.M.) 2 Division of Psychology & Mental Health, University of Manchester, Manchester M13 9WL, UK; rachel.calam@manchester.ac.uk * Correspondence: aala.el-khani@un.org

  BACKGROUND

• Prevention, Treatment and Rehabilitation Section, Drug Prevention and Health Branch, Division of Operations, United Nations Office on Drugs and Crime (UNODC), Wagramer Strasse 5, A-1400 Vienna, Austria; ali.yassine@un.org (A.Y.); karin.haar@un.org (K.H.); wadih.maalouf@un.org (W.M.) 2 Drug Demand Reduction Division, United Nations Office on Drugs and Crime (UNODC), Menara Thamrin Building 10th Floor, Central Jakarta, Jakarta 10250, Indonesia; narendra.narotama@un.org (N.N.); lucky.pramitasari@un.org (L.P.) 3 Charitas Hospital Palembang, Central Jakarta, Jakarta 30129, Indonesia; melvi.rosilawati@gmail.com * Correspondence: aala.el-khani@un.org

  BACKGROUND

• Prevention, Treatment and Rehabilitation Section, Drug Prevention and Health Branch, Division of Operations, United Nations Office on Drugs and Crime (UNODC), Wagramer Strasse 5, A-1400 Vienna, Austria; Aala.elkhani@gmail.com (A.E.-K.); Karin.haar@un.org (K.H.) 2 United Nations Office on Drugs and Crime, Program Office Serbia, Bulevar Zorana Djindjica 64, 11000 Belgrade, Serbia; Milos.stojanovic@un.org * Correspondence: Wadih.maalouf@un.org † Authors' information: The views expressed in this Article do not necessarily reflect the views of the United Nations or its officials or Member States.

  BACKGROUND

• Haar K, El-Khani A, Molgaard V, Maalouf W; Afghanistan field implementation team. Strong families: a new family skills training programme for challenged and humanitarian settings: a single-arm intervention tested in Afghanistan. BMC Public Health. 2020 May 7;20(1):634. doi: 10.1186/s12889-020-08701-w.

  PMID: 32381064 BACKGROUND

Related Links

• To support breaking the vicious cycle of families reproducing negative coping patterns, the United Nations Office on Drugs and Crime (UNODC) has been implementing a global initiative on prevention piloting evidence-based family skills prevention in low-

MeSH Terms

Conditions

Communication

Interventions

Psychosocial Intervention

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Aala El Khani

  United Nations Office on Drugs and Crime (UNODC)

  PRINCIPAL INVESTIGATOR

• Wadih Maalouf

  United Nations Office on Drugs and Crime (UNODC)

  STUDY DIRECTOR

• Olivier Lermet

  United Nations Office on Drugs and Crime (UNODC)

  STUDY DIRECTOR

• Aimee Rose Manda, PhD

  Polytechnique University of the Philippines

  PRINCIPAL INVESTIGATOR

• Geraldine F Santos, PhD

  Polytechnique University of the Philippines

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Method * Caregivers will complete a battery of questionnaires, right before intervention(Time 1), two weeks post intervention (Time 2) and also six weeks post intervention (Time 3) * Semi-Structured interviews with a selected group of parents that have completed the Strong Families programme and facilitators Caregiver measures 1. Family Demographics Questionnaire: FDQ 2. Strengths and Difficulties Questionnaire: SDQ (Goodman, 1997) - behavioral screening questionnaire (25 items) 3. Parental and Family Adjustment Scale: PAFAS (Sanders, Morawska, Haslam, Filus \& Fletcher, 2014) measures parenting practices and parental adjustment (30 items), this has been developed to be used in low resource settings 4. (Person Most Knowledgeable) Child and Youth Resilience Measure: PMK-CYRM-R (Jefferies, P., McGarrigle, L., \& Ungar, M. (2018)

Study Record Dates

• First Submitted: July 9, 2023
• First Posted: July 17, 2023
• Study Start: February 28, 2023
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: September 18, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

PH (5)