Clinical trial NCT03903445: Masayang Pamilya Feasibility Study
Official title: Feasibility Study of the Masayang Pamilya Para sa Batang Pilipino (MaPa) Program From Families With Children and Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parent-Child Relations
Child Maltreatment
Child Behavior Problem
Parenting
Keywords: Parenting Program
Lead sponsor: Ateneo de Manila University
Sponsor class: OTHER
Collaborators: name: University of Oxford
name: University of Cape Town
name: Philippines Department of Social Welfare and Development
name: Philippines Child Protection Network
First posted: 2019-04-04
Enrollment: 120
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pre-post evaluation of 2 separate interventions (no comparison)
Primary purpose: PREVENTION

Brief summary: The aim of this study is to test the feasibility of (1) an 8-session version of the Masayang Pamilya (MaPa) parenting program for families with children aged 2-9 (MaPa Kids) and (2) a culturally and contextually adapted 9-session MaPa parenting program for families with children aged 10-17 (MaPa Teens).

The feasibility of MaPa Kids and MaPa Teens will be assessed through self-report questionnaires, in-depth interviews and focus group discussions, and implementation data. Together, the focus groups, questionnaires, interviews, and implementation data will assess the overall feasibility of the MaPa Kids and MaPa Teen programs in the Philippines by examining program delivery, participation, acceptability, scalability, and preliminary effectiveness on reducing child maltreatment and associated risks.

Detailed description: Child maltreatment occurs at much higher rates in low- and middle-income countries (LMIC) than in high-income countries. Parenting programs have shown particular promise in preventing child maltreatment, as well as improving child health and educational outcomes. However, there are currently very few parenting programs that are both evidence-based and affordable for LMIC, such as the Philippines, where the need is the greatest. For instance, the 2015 national baseline survey on violence against children (VAC) revealed that 80% of Filipino youth respondents had experienced violence in childhood, with 60% of these cases occurring at home. Mothers, fathers, and siblings were the most commonly reported perpetrators of harsh physical and psychological punishment (UNICEF, 2016). A logical recourse to decrease child maltreatment in the country is to implement interventions/programs that improve parents' relationships with their children and their knowledge and skills in child behavior management.

There is extensive scientific evidence that parenting support programs are effective in reducing child maltreatment and associated risk factors such as corporal punishment and parent negative psychological health (e.g., Desai, Reece \& Shakespeare-Pellington, 2017; Mikton \& Butchart, 2009). Parenting for Lifelong Health (PLH) is one such initiative led by UNICEF and WHO to support evidence-based parenting programs to reduce VAC in low and middle-income contexts.

In 2016-2017, PLH-Philippines embarked on the cultural adaptation, feasibility study (N=30), and pilot randomized control trial (RCT) (N=120) of the MaPa Kids program in the National Capital Region, which was implemented with families with children ages 2-6 and who were beneficiaries of the Department of Social Welfare and Development (DSWD) Pantawid Pamilyang Pilipino Program (4Ps). The results of this initial RCT were promising with reduced child maltreatment, dysfunctional parenting, less support of corporal punishment, lower levels of child problem behavior intensity, and higher sense of parenting efficacy at post-intervention reported by parents who participated in MaPa Kids compared to control group families who underwent the 4Ps Family Development Sessions (FDS). Reduced child maltreatment persisted at one-year follow-up assessment.

Building on the aforementioned trial, this study aims to expand the development, implementation, and evaluation of the parenting programs in the Philippines as part of a systematic effort to further assess the feasibility of (1) an 8-session version of the MaPa Kids program for families with children aged 2-9 and (2) a culturally adapted 9-session parenting program for families with children aged 10-17 (MaPa Teens).

The 8-session MaPa Kids and 9-session MaPa Teens modules will be piloted through a pre-post feasibility study. Both MaPa Kids and MaPa Teens parenting intervention modules will be implemented by eight local facilitators and two coaches in a low-income community - in Quezon City, Philippines - identified in collaboration with DSWD. Following participant recruitment and informed consent and assent procedures, baseline sociodemographic information and primary, proximal, and secondary information will be collected from parents/caregivers and their children (aged 10-17 in MaPa Teens).

Standardized baseline and one-month post-program questionnaires assessing primary and secondary outcomes, as well as demographic data, will be administered to 60 parents/primary caregivers and 30 children who participate in the program. Implementation data will be collected from parents/caregivers and program facilitators through report forms/checklists and video-recordings of each program session. Focus group discussions will be held with 60 parents/primary caregivers, 30 children aged 10-17, and eight program facilitators.

Eligibility criteria: Eligibility criteria Participants must have provided written, informed consent prior to the occurrence of any study procedures.

Inclusion criteria for participating parents or caregivers (N=60):

1. Age 18 or older;
2. Primary caregiver responsible for the care of a child between the ages 2-9 (Kids) or 10-17 (Teens);
3. Spend at least four nights a week in the same household as the child in the previous month;
4. Recipient of the 4Ps conditional cash transfer program;
5. Provision of consent to participate in the full study;
6. Provision of consent for their child to participate in the full study (for MaPa Teens only).

Exclusion criteria for adult parents:

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

Inclusion criteria for child respondents (N=30):

1. Age 10 to 17 years at initial assessment;
2. Lives in the house at least 4 nights per week;
3. Must have an adult primary caregiver who lives in the household, who provides consent, and who participates in the study;
4. Provides assent to participate in the full study.

Exclusion criteria for child respondents:

1. Any child who is either experiencing severe mental health problems, has acute developmental disabilities and
2. If the child participant has been referred to social services during baseline data collection due to reported or observed indications of significant harm.

The study will also assess program fidelity and quality of delivery by program facilitators (N=8). These facilitators and coaches will have the following inclusion criteria:

1. Age 18 or older;
2. Prior participation in a 5-day facilitator training workshop;
3. Agreement to implement the entire program;
4. Provision of consent to participate in the full study.

Primary outcomes:
measure: Child maltreatment of young children - physical and emotional abuse: ISPCAN Child Abuse Screening Tool-Trial Parent-Child Version (ICAST-TPC) - Parent Report
timeFrame: Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 4 months post pre-assessment)
measure: Child maltreatment of adolescents - physical and emotional abuse: ISPCAN Child Abuse Screening Tool-Trial Parent-Adolescent Version (ICAST-TPA) - Parent Report
timeFrame: Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 4 months post pre-assessment)
measure: Child maltreatment of adolescents - physical and emotional abuse: ISPCAN Child Abuse Screening Tool-Trial Adolescent Version (ICAST-TA) - Child Report
timeFrame: Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 4 months post pre-assessment)
Secondary outcomes:
measure: Child maltreatment of young children - physical abuse: ISPCAN Child Abuse Screening Tool-Trial Parent-Child Version (ICAST-TPC) - Parent Report
timeFrame: Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 4 months post pre-assessment)
measure: Child maltreatment of young children - emotional abuse: ISPCAN Child Abuse Screening Tool-Trial Parent-Child Version (ICAST-TPC) - Parent Report
timeFrame: Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 4 months post pre-assessment)
measure: Child maltreatment of adolescents - physical abuse: ISPCAN Child Abuse Screening Tool-Trial Parent-Adolescent Version (ICAST-TPA) - Parent Report
timeFrame: Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 4 months post pre-assessment)
measure: Child maltreatment of adolescents -emotional abuse: ISPCAN Child Abuse Screening Tool-Trial Parent-Adolescent Version (ICAST-TPA) - Parent Report
timeFrame: Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 4 months post pre-assessment)
measure: Child maltreatment - physical abuse: ISPCAN Child Abuse Screening Tool-Trial Adolescent Version (ICAST-TA) - Child Report
timeFrame: Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 4 months post pre-assessment)
measure: Child maltreatment - emotional abuse: ISPCAN Child Abuse Screening Tool-Trial Adolescent Version (ICAST-TA) - Child Report
timeFrame: Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 4 months post pre-assessment)
measure: Child neglect: ICAST-T Caregiver Neglect Subscale - Parent Report
timeFrame: Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 4 months post pre-assessment)
measure: Child neglect: ICAST-T Caregiver Neglect Subscale - Child Report
timeFrame: Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 4 months post pre-assessment)
measure: Parental monitoring: Adapted Parental Monitoring Scale - Parent Report, MaPa Teens Only
timeFrame: Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 4 months post pre-assessment)
measure: Parental monitoring: Adapted Parental Monitoring Scale - Child Report, MaPa Teens Only
timeFrame: Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 4 months post pre-assessment)
measure: Child behavior problems: Child and Adolescent Behavior Inventory (CABI) - Parent Report
timeFrame: Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 4 months post pre-assessment)
measure: Child behavior problems: Child and Adolescent Behavior Inventory (CABI) - Child Report
timeFrame: Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 4 months post pre-assessment)
measure: Three Problem Rating Scale - Child Report
timeFrame: Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 4 months post pre-assessment)
measure: Three Problem Rating Scale - Parent Report
timeFrame: Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 4 months post pre-assessment)
measure: Parenting efficacy: Parenting Sense of Competence Scale (PSOC-ES) - Parent Report
timeFrame: Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 4 months post pre-assessment)
measure: Parenting stress: Parental Stress Scale (PSS) - Parent Report
timeFrame: Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 4 months post pre-assessment)
measure: Self-efficacy in managing emotions - Regulatory Emotional Self-Efficacy Scale - Parent Report
timeFrame: Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 4 months post pre-assessment)
measure: Parental depressive symptoms - Moods and Feelings Questionnaire (MFQ) - Parent Report
timeFrame: Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 4 months post pre-assessment)
measure: Child depressive symptoms - Moods and Feelings Questionnaire (MFQ) - Parent Report
timeFrame: Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 4 months post pre-assessment)
measure: Child depressive symptoms - Moods and Feelings Questionnaire (MFQ) - Child Report
timeFrame: Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 4 months post pre-assessment)
measure: Parent exposure to intimate partner violence and intimate partner coercion - Revised Conflict Tactics Scale Form (CTS2S) - Parent Report
timeFrame: Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 4 months post pre-assessment)
measure: Parent exposure to intimate partner violence and intimate partner coercion - WHO Multi-Country Study Questionnaire- Parent Report
timeFrame: Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 4 months post pre-assessment)
measure: Family functioning - Burmese Family Functioning Scale - Parent Report
timeFrame: Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 4 months post pre-assessment)
measure: Family functioning - Burmese Family Functioning Scale - Child Report
timeFrame: Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 4 months post pre-assessment)
measure: Community violence exposure: Violence Exposure Scale - Parent Report
timeFrame: Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 4 months post pre-assessment)
measure: Community violence exposure: Violence Exposure Scale - Child Report
timeFrame: Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 4 months post pre-assessment)
measure: Positive parenting: Parenting of Young Children Scale (PARYC) - Parent Report, MaPa Kids Only
timeFrame: Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 4 months post pre-assessment)
measure: Dysfunctional parenting: Parenting Scale (PS) - Parent Report, MaPa Kids Only
timeFrame: Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 4 months post pre-assessment)
measure: Parenting behavior: Alabama Parenting Questionnaire - Parent Report, MaPa Teens Only
timeFrame: Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 4 months post pre-assessment)
measure: Parenting behavior: Alabama Parenting Questionnaire - Child Report, MaPa Teens Only
timeFrame: Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 4 months post pre-assessment)
measure: Attitudes toward punishment: UNICEF Multiple Indicator Cluster Survey (MICS) 5 Child Discipline Module - Parent Report
timeFrame: Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 4 months post pre-assessment)
measure: Attitudes toward punishment: UNICEF Multiple Indicator Cluster Survey (MICS) 5 Child Discipline Module - Child Report
timeFrame: Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 4 months post pre-assessment)
measure: Attitudes towards punishment: ISPCAN Child Abuse Screening Tool-Intervention and Efficacy and Attitudes Sub-Scales - Parent Report
timeFrame: Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 4 months post pre-assessment)
measure: Attitudes towards punishment: ISPCAN Child Abuse Screening Tool-Intervention and Efficacy and Attitudes Sub-Scales - Child Report
timeFrame: Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 4 months post pre-assessment)
measure: Child prosocial behavior: Prosocial Behavior Scale - Child Report
timeFrame: Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 4 months post pre-assessment)
measure: Child risk behavior: Risk Behavior Scale - Child Report
timeFrame: Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 4 months post pre-assessment)
measure: Witnessing family violence: ICAST-T Child - Child Report
timeFrame: Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 4 months post pre-assessment)
measure: Parental Support for School - Parent Report
timeFrame: Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 4 months post pre-assessment)
measure: Parental Support for School - Child Report
timeFrame: Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 4 months post pre-assessment)
measure: Educational Aspirations - Parent Report
timeFrame: Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 4 months post pre-assessment)
measure: Educational Aspirations - Child Report
timeFrame: Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 4 months post pre-assessment)
measure: Educational Expectations - Parent Report
timeFrame: Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 4 months post pre-assessment)
measure: Educational Expectations - Child Report
timeFrame: Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 4 months post pre-assessment)
Other outcomes:
measure: Recruitment rate
timeFrame: Post (approx. 1 month after end of intervention, i.e., 4 months post pre-assessment)
measure: Enrollment rate
timeFrame: Post (approx. 1 month after end of intervention, i.e., 4 months post pre-assessment)
measure: Participation rate
timeFrame: Post (approx. 1 month after end of intervention, i.e., 4 months post pre-assessment)
measure: Implementation Dosage in hours
timeFrame: Post (approx. 1 month after end of intervention, i.e., 4 months post pre-assessment)
measure: Implementation Dosage (points of contact)
timeFrame: Post (approx. 1 month after end of intervention, i.e., 4 months post pre-assessment)
measure: Implementation Fidelity (percentage of session activities delivered per session)
timeFrame: Post (approx. 1 month after end of intervention, i.e., 4 months post pre-assessment)
measure: Implementation Fidelity (mean percent of activities delivered per session)
timeFrame: Post (approx. 1 month after end of intervention, i.e., 4 months post pre-assessment)
measure: Implementation Quality
timeFrame: Post (approx. 1 month after end of intervention, i.e., 4 months post pre-assessment)
measure: Participants observed change in parenting practices and child behaviour at home during program
timeFrame: Post (approx. 1 month after end of intervention, i.e., 4 months post pre-assessment)
measure: Existing barriers to participation during sessions and engagement in home practice and other activities
timeFrame: Post (approx. 1 month after end of intervention, i.e., 4 months post pre-assessment)
measure: Challenges in implementing the program
timeFrame: Post (approx. 1 month after end of intervention, i.e., 4 months post pre-assessment)
measure: Basic caregiver and child demographic information
timeFrame: Baseline
measure: Household ladder - Parent Report
timeFrame: Baseline
measure: Household income - Parent Report
timeFrame: Baseline
measure: Adult history of child maltreatment - Parent Report
timeFrame: Baseline
measure: Basic necessities - Parent and Child Report
timeFrame: Baseline
measure: Household hunger - Parent Report
timeFrame: Baseline
measure: Food consumption - Parent Report
timeFrame: Baseline
measure: Caregiver alcohol use - Parent Report
timeFrame: Baseline
Locations:
city: Quezon City
country: Philippines
facility: Ateneo de Manila University
Study officials:
affiliation: Ateneo de Manila University
name: Rosanne Jocson, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ateneo de Manila University
name: Liane P Alampay, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Oxford
name: Jamie M Lachman, DPhil
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Oxford
name: Frances Gardner, DPhil
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Social Welfare and Development, Philippines
name: Engels Del Rosario
role: PRINCIPAL_INVESTIGATOR
affiliation: Child Protection Network, Philippines
name: Bernadette Madrid, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Cape Town
name: Catherine L Ward, PhD
role: PRINCIPAL_INVESTIGATOR
References: