NCT03205449

Brief Summary

Parenting for Lifelong Health (PLH) Philippines Evaluation Study: Multisite randomised controlled trial to compare the efficacy of a culturally-adapted parenting programme, Masayang Pamilya, versus services as usual in the reduction of child maltreatment and improvement of child wellbeing in low-income Filipino families with children aged two to six years in Metro Manila (N = 120). A previous study focused on adaptation and feasibility testing was conducted from January 2016 to February 2017. Community-based participatory approaches were used to culturally adapt the Sinovuyo programme to a Filipino context. A formative evaluation using qualitative in-depth interviews and focus group discussions with parents, as well as consultative workshops with service providers and other stakeholders, examined issues regarding the needs and concerns of Filipino parents, appropriateness of intervention components and delivery, and other specific cultural issues in order to balance "fidelity" to evidence-based practices with "fit" to the local context \[11\]. The Sinovuyo programme was then adapted into the MaPa programme with local materials and approaches developed to fit the Philippine cultural context based on findings from the formative evaluation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 16, 2017

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

June 26, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 2, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2019

Completed
Last Updated

February 26, 2019

Status Verified

February 1, 2019

Enrollment Period

1.6 years

First QC Date

June 26, 2017

Last Update Submit

February 25, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in frequency of child maltreatment

    Child maltreatment will be measured using parent report of the ISPCAN Child Abuse Screening Tool-Intervention scale (19 items, ICAST-I), an adaptation of a multi-national and consensus-based survey instrument measuring parent-report the incidence and prevalence of child abuse and neglect (ICAST-P). It was validated in 6 LMIC and 7 languages (α = 0.77-0.88) and measures four types of abuse: physical, emotional and sexual abuse, as well as neglect. Response code for the ICAST-I was adapted to a scale from 0 to more than 8 times to assess the frequency of a certain behaviour in the past month. This study will assess incidence of child maltreatment by creating dichotomous variables for physical abuse, verbal abuse, and neglect, as well as an overall indication of previous child abuse (0 = no abuse; 1 = previous abuse). We will also assess frequency of overall abuse by summing all of the subscales as well as for each individual subscale.

    Change from baseline at 7 months and at 19 months

Secondary Outcomes (15)

  • Change in frequency of positive parenting

    Change from baseline at 7 months and at 19 months

  • Change in frequency of dysfunctional parenting

    Change from baseline at 7 months and at 19 months

  • Change in levels of endorsement of physical punishment

    Change from baseline at 7 months and at 19 months

  • Change in number of daily child behavior problems and parenting behaviors

    Change from baseline at 7 months and at 19 months

  • Change in number of child behavior problems

    Change from baseline at 7 months and at 19 months

  • +10 more secondary outcomes

Other Outcomes (6)

  • Implementation fidelity

    7 months after baseline and at 19 months

  • Quality of delivery

    7 months after baseline and at 19 months

  • Program adherence

    7 months after baseline and at 19 months

  • +3 more other outcomes

Study Arms (2)

MaPa Programme

EXPERIMENTAL

Masayang Pamilya Parenting Program: A 12-session, a group-based parenting programme focused on reducing violence against children and improving child wellbeing in low-income families with young children

Behavioral: Masayang Pamilya Para Sa Batang Pilipino Parenting Programme (MaPa)

Treatment-as-usual

ACTIVE COMPARATOR

Parenting Effectiveness Service programme: A family strengthening programme delivered by trained service providers on a monthly basis.

Other: Parenting Effectiveness Service

Interventions

The MaPa programme includes the following content: 1) spending one-on-one time with children; 2) describing actions and feelings for cognitive development and socio-emotional awareness; 3) using praise and rewards to encourage positive behaviour; 4) establishing limits through effective instruction giving and consistent household rules; 5) nonviolent discipline such as ignoring negative attention seeking behaviour, and consequences for noncompliance, rule-breaking, and aggressive behaviour; 6) problem solving with children; and 7) mindfulness based stress reduction for caregivers.

Also known as: MaPa Programme
MaPa Programme

Content uses a thematic manual that includes sessions on Filipino family dynamics, early childhood development, child behaviour management, marital relationships, prevention of child maltreatment, health care, nutrition, and government anti-poverty initiatives, as well as disaster preparedness. \[12\].

Also known as: PES
Treatment-as-usual

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 or older;
  • Primary caregiver responsible for the care of a child between the ages of two and six who is staying in the same household at least four nights a week in the previous month;
  • Spend at least four nights a week in the same household as the child;
  • Unemployed parent;
  • Recipient of the 4Ps conditional cash transfer programme;
  • Agreement to participate in the MaPa programme if allocated to the treatment condition;
  • Provision of consent to participate in the full study.

You may not qualify if:

  • Any adult who has already participated in the Parent Effectiveness Service;
  • Any adult exhibiting severe mental health problems or acute mental disabilities;
  • Any adult that has been referred to child protection services due to child abuse.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barangay Western Bicutan

City of Taguig, National Capital Region, Philippines

Location

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Study Officials

  • Liane P Alampay, PhD

    Ateneo de Manila University

    PRINCIPAL INVESTIGATOR
  • Jamie M Lachman, PhD

    University of Oxford

    PRINCIPAL INVESTIGATOR
  • Cecilia Alinea, MD

    Philippine Ambulatory Pediatric Association

    PRINCIPAL INVESTIGATOR
  • Frances Gardner, PhD

    University of Oxford

    PRINCIPAL INVESTIGATOR
  • Judy Hutchings, PhD

    Bangor University

    PRINCIPAL INVESTIGATOR
  • Catherine Ward, PhD

    University of Cape Town

    PRINCIPAL INVESTIGATOR
  • Bernadette Madrid, MD

    International Child Protection Network

    PRINCIPAL INVESTIGATOR
  • Rosanne Jocson, PhD

    Ateneo de Manila University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This study will use a randomised controlled trial design to test the effects of the Masayang Pamilya programme in comparison to participants allocated to a treatment as usual control group (N = 120 parents of children ages 2 to 6 years; 1:1 intervention to control group ratio).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2017

First Posted

July 2, 2017

Study Start

June 16, 2017

Primary Completion

February 5, 2019

Study Completion

February 5, 2019

Last Updated

February 26, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations