Parenting for Lifelong Health (PLH) - Masayang Pamilya (MaPa) Evaluation Study

Child Maltreatment Clinical Trial

— PLH-MaPa  

Official title:

Parenting for Lifelong Health-Philippines: Randomized Controlled Trial of a Culturally-adapted Parenting Program on Reducing the Risk of Violence Against Children in Low-income Filipino Families With Children Aged 2 to 6 Years in Manila

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03205449
• Other study ID #: AdMUREC_16_090
• Status: Completed
• Phase: N/A
• Start date: June 16, 2017
• Est. completion date: February 5, 2019

Study information

• Verified date: February 2019
• Source: Ateneo de Manila University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Over the past decade there have been increasing calls for the scale-up of evidence-based interventions in order to reduce the risk of violence against children in low- and middle-income countries (LMICs) [1]. In particular, parenting programmes for families with young children have been shown to be effective in reducing the risk of child maltreatment and improving child wellbeing with promising evidence emerging from low- and middle-income countries [2-4]. These group-based programmes typically aim to strengthen caregiver-child relationships through positive parenting and to help parents to manage child behaviour problems through effective, age-appropriate, nonviolent discipline strategies.

Despite the emerging evidence of the effectiveness of parenting interventions in reducing violence against children, many local governments and service providers in LMICs face multiple challenges implementing evidence-based parenting programs in resource poor contexts [5]. Parenting programmes are often too expensive to deliver effectively at scale in low-resource settings due to their complexity, intensity, and length [3]. Parenting programmes developed and evaluated in other contexts also may not fit the local service delivery context and may require adaptation to be relevant to the local culture of families. Additional programme content may also be necessary to address stress related to economic deprivation, high community violence, and parental distress. The process of delivery may also need to be simplified to improve participant engagement and the quality of delivery.

As a result, it is essential that programmes implemented in LMICs are 1) effective at reducing violence against children, 2) integrated within the existing service delivery system, 3) feasible and culturally acceptable to service providers and families, and 4) scalable in terms of their affordability, replicability, and sustainability while reaching a maximum number of beneficiaries. However, there are currently very few parenting programmes that meet these criteria in LMICs, such as the Philippines, where the need is the greatest [3].

The PLH Philippines Evaluation Study aims to fill this gap by examining the efficacy of a locally-adapted, evidence-based parenting programme, the Masayang Pamilya Para Sa Batang Pilipino Parenting Programme (MaPa), for families with children ages two to six years living in Metro Manila who are enrolled in the Philippine Department of Social Welfare and Development (DSWD) conditional cash transfer system.

Our overall objective is to use a randomised controlled trial design to test the efficacy of the MaPa programme in reducing the risk of child maltreatment while improving child socio-emotional development, child behaviour, and parental mental health in comparison to treatment as usual controls in Metro Manila.

Our primary objective is to examine the impact of the MaPa programme on the primary outcome of child maltreatment in comparison to treatment-as-usual controls at immediate post-intervention and at 1-year follow-up.

Our secondary objective is to examine the impact of the MaPa programme on proximal outcomes associated with increased risks of child maltreatment, namely, positive parenting, intrusive parenting, and harsh parenting in comparison to treatment-as-usual controls at immediate post-intervention and at 1-year follow-up.

Another secondary objective is to examine the impact of the MaPa programme at immediate post-intervention and at 1-year follow-up on child behaviour problems, child development outcomes (i.e., communication skills and socio-emotional development), parenting efficacy, parental wellbeing, parenting stress, parental depression, marital satisfaction, and intimate partner violence, in comparison to treatment as usual controls.

Our tertiary objective is to examine the implementation of the MaPa programme when delivered within the DSWD conditional cash transfer system in terms of programme adherence by parents (i.e., recruitment, enrolment, attendance, engagement, dropout, and completion) and delivery by service providers (i.e., competency and fidelity).

Our final objective is to examine predictors of programme adherence and associations between programme adherence and primary and secondary outcomes at immediate post-test and at 1-year follow-up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: February 5, 2019
• Est. primary completion date: February 5, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Child Maltreatment

Intervention

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

Other:
• Parenting Effectiveness Service
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].

Locations

Country	Name	City	State
Philippines	Barangay Western Bicutan	Taguig	Metro Manila

Sponsors (9)

Lead Sponsor	Collaborator
Ateneo de Manila University	Bangor University, International Child Protection Network, Philippine Ambulatory Pediatric Association, Philippine Department of Social Welfare and Development, The UBS Optimus Foundation, UNICEF, University of Cape Town, University of Oxford

Country where clinical trial is conducted

Philippines, 

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* Note: There are 56 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Implementation fidelity	Implementation fidelity by program facilitators of the MaPa program will be measured using self-report checklists by program implementers will examine the extent to which core intervention components are delivered. These checklists will include specific activities for each session, such as home practice discussion and role-playing exercises. Then, in order to produce a basic level of fidelity, a ratio of program implementation to program design will be created for both self-report and observational scores [117]. According to Borrelli and colleagues, a standard of 80% program fidelity will be considered as "high treatment fidelity" [118].	7 months after baseline and at 19 months
Other	Quality of delivery	Quality of delivery will be assessed using the Parenting for Lifelong Health Facilitator Assessment Tool (PLH-FAT) [60]. The PLH-FAT was developed by the study investigators and programme developers to assess the proficiency of programme delivery by facilitators as a prerequisite to certification. Seven standard behaviour categories are grouped into two scales based on the core activities (23 items) and process skills (28 items) as outlined in the programme manual [6]. Assessment of core activities includes quality of delivery during home activity review (14 items, e.g., "identify specific challenges when shared by at least one parent"), illustrated story discussion (7 items, e.g., "discuss possible solutions for negative stories"), and practicing skills (10 items, e.g., "debrief with the participants about experience and feelings"). Assessment of process skills includes modelling skills (6 items, e.g., "give positive, specific, and realistic instructions"), collaborative facilitation	7 months after baseline and at 19 months
Other	Program adherence	Program adherence will be assessed by examining rates of enrolment, attendance, dropout, completion, and engagement of home activities. Enrolment rates will be based on the ratio of those allocated to the MaPa or PES intervention and those who attend at least one session. Mean attendance rates for enrolled participants will be determined based on the ratio of number of attended sessions to the total number of program sessions (MaPa = 12 sessions; PES = 9 sessions). Dropout rates for enrolled participants will be defined as the percentage of participants who fail to attend at least three consecutive sessions and do not attend any sessions at a later stage. Completion rates for the entire allocation group will be determined based on the number of enrolled participants who attend a cut-off threshold of at least 66% of the program. Engagement in home activities will be assessed using parent-report of home activity completion forms and by examining transcripts from parent group session.	7 months after baseline and at 19 months
Other	Engagement in home activities	Engagement in home activities will be assessed using parent-report of home activity completion forms and by examining transcripts from parent group sessions. During each session, parents will report whether they were able to implement the assigned home activity activities from the previous week according to the intervention protocol. A weekly rate of engagement will be calculated based on the ratio of completed assignments to the number of parents in attendance during the session. Finally, an overall rating of engagement will be determined by summing each weekly rate. Although it is possible that non-attendees will also complete home activities, this study will only examine engagement based on those in attendance at any given session.	7 months after baseline and at 19 months
Other	Participant satisfaction	Participant satisfaction will be examined for families who attend at least one session of the MaPa program [120]. Mean and standard deviation scores will be reported for the overall participation satisfaction scale (40 items), as well as for subscales (i.e., whether the program fulfilled their expectations, acceptability of delivery and teaching methods, acceptability of theoretical parenting techniques, and evaluation of program facilitators).	7 months after baseline and at 19 months
Other	Program acceptability and participation	This study will also assess program acceptability and participation using qualitative in-depth interviews with intervention participants (n = 12) and focus groups with the facilitators (n = 8) in order to explore program acceptability. Participants will be purposively selected from the intervention group with the inclusion criteria of attending at least one intervention session. Selection will be based on those with high attendance (n = 3), those with low attendance (n = 3), those who dropout (n = 3), and those who do not enroll (n = 3). Interviews and focus groups will occur during the post-evaluation and examine the following themes: 1) participants observed change in parenting practices and child behavior at home during program; 2) acceptability and appropriateness of program materials, delivery, and key program components; and 3) existing barriers to participation during sessions and engagement in home practice and other activities.	7 months after baseline and at 19 months
Primary	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 (a = 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	Change in frequency of positive parenting	Positive parenting behavior will be assessed using the Parenting of Young Children Scale (PARYC, 21 items) [5]. The PARYC measures the frequency of parent behavior over the previous month. Items are summed to create total frequency scores for positive parenting (7 items, e.g., "how often do you play with your child"), setting limits (7 items, e.g., "how often do you stick to your rules and not change your mind") and proactive parenting (7 items, e.g., "how often do you explain what you want your child to do in clear and simple ways"). It has been used with strong reliability in previous studies on the program adapted in this study [20].	Change from baseline at 7 months and at 19 months
Secondary	Change in frequency of dysfunctional parenting	Dysfunctional parenting behavior will be assessed using the Parenting Scale (PS, 30 items) [6]. This scale examines parent attitudes and beliefs regarding discipline practice. Responses are based on a 7-point Likert scale in which parents are presented with a situation and then are asked to choose between two alternative responses to a situation (1 = most effective; 7 = most ineffective; i.e., situation: "When I say my child can't do something;" response, score = 1: "I stick to what I said;" or response score = 7: "I let my child do it anyway"). Items are summed to create an overall score as well as for three subscales: Laxness, Over-reactivity, and Verbosity. The PS has been used widely to assess the effectiveness of parenting programs, including in low-resource settings such as Panama [21].	Change from baseline at 7 months and at 19 months
Secondary	Change in levels of endorsement of physical punishment	This study will ask one question from the UNICEF Multiple Indicator Cluster Survey [1] regarding parental attitudes to physical discipline based on a 5-point Likert scale of 0 to 4: "In order to bring up, raise up, or educate a child properly, the child needs to be physically punished." Caregivers will report whether they disagree or agree with the statement (0 = disagree strongly; 4 = agree strongly).	Change from baseline at 7 months and at 19 months
Secondary	Change in number of daily child behavior problems and parenting behaviors	An adapted version of Parent Daily Report Checklist (PDR, 44 items) will be used to assess day-to-day occurrences of child behavior problems and parenting behavior [12]. It was designed to avoid potential challenges parents may have in recalling events in retrospective scales, and has been used widely in multiple contexts as an assessment of child and parent behavior change during program delivery [46-49]. The PDR does not assess frequency of behavior but rather the occurrence (i.e., "Yes" or "No"). Parents indicate whether a child behavior occurred within the previous 24 hours (35 items, e.g., complaining, lying). In order to assess parenting behavior, this study will also ask parents about their own behavior (6 items, e.g., used physical discipline, or praised child) and self-efficacy (3 items, e.g., had a feeling that I could not cope with parenting).	Change from baseline at 7 months and at 19 months
Secondary	Change in number of child behavior problems	The Eyberg Child Behavior Inventory assesses child behavior problems [30]. This 36-item survey examines externalizing behavior problems in children ages 2 to 16 using both an Intensity Scale and Problem Scale. Parents are asked how often a specific behavior occurs and whether the behavior is considered a problem. Items based on the most typical child behavior problems. The Intensity Scale rates frequency of occurrence based on a 7-point Likert-like scale (1 = never occurs; 7 = always occurs). The Problem Scale measures whether the parent identifies a specific behavior as a problem (0 = no; 1 = yes). Both scales are summed up to create a total Intensity Score and Problem Score. The ECBI has been used extensively throughout the world as a diagnostic tool as well as to evaluate parenting programs in RCTs [31-34]. Clinical cut-off scores suggested for psychopathological problem behavior are 131 for the Intensity Score and 15 for the Problem Score [35].	Change from baseline at 7 months and at 19 months
Secondary	Change in levels of child development - communication skills	Child development will be assessed using the communication subscale of the parent-report version of the Ages and Stages Questionnaires, Version 3 (ASQ-3) [13]. This 6-item screening tool measures infant and toddler development of communication skills from 2 months to 6 years of age. Distinct items are administered according to the child's age in 2-month intervals rounded to the nearest interval. The ASQ-3 is administered via caregiver self-report based on "Yes," "Sometime," or "Not Yet" for each developmental milestone. In addition, if the caregiver is not sure of a specific item, s/he is given the opportunity to perform the task with his/her infant or toddler during the assessment. Items for each subscale are summed to create total scores as well as an overall indication of child development. Cut-off scores will be used based on international ASQ cut-offs according to the manual for normal development, borderline delay, and developmental delay [13].	Change from baseline at 7 months and at 19 months
Secondary	Change in levels of child socio-emotional development	Child socio-emotional development will be assessed using the parent-report version of the Ages and Stages Questionnaires: Social-Emotional, Version 2 (ASQ-SE2) [14, 36]. This screening tool was designed to specifically assess socio-emotional development for children from 1 month to 6 years of age. Questionnaires are administered to the parent depending on the age of the child (i.e., 24, 30, and 36 month intervals). Items examine seven domains of socio-emotional development: self-regulation, compliance, adaptive functioning, autonomy, affect, social-communication, and interaction with others. Parents report on whether the specific child behavior occurs "often or always," "sometimes," or "rarely or never," as well as whether the behavior is a concern for the parent (yes/no). The ASQ:SE has been used extensively as a global screening tool, including multiple low- and middle-income countries [37-41].	Change from baseline at 7 months and at 19 months
Secondary	Change in levels of parent efficacy	Parenting efficacy will be assessed using the Efficacy Subscale of the Parenting Sense of Competence Scale (8 items; PSOC-ES) [37]. The PSOC has been widely used in studies to evaluate parenting self-esteem, efficacy, or competence [37]. The PSOC Efficacy Subscale measures parental perception of competence, problem-solving ability, and capability in the parenting role (e.g., ""I honestly believe I have all the skills necessary to be a good mother/father to my child"). Each item is rated on a 6-point scale that ranges from 1 (strongly disagree) to 6 (strongly agree). Items are summed to create a total score of parental self-efficacy.	Change from baseline at 7 months and at 19 months
Secondary	Change in levels of parenting stress	Parenting stress will be measured using the Parenting Stress Index (PSI) (36 items) [8]. This scale has been used widely throughout the world [22-25], including prior use in low- and middle-income countries [26, 27]. Items include subscales for parental distress (e.g., "I often have the feeling that I cannot handle things very well"), parent-child dysfunction (e.g., "Sometimes I feel my child doesn't like me and doesn't want to be close to me"), and difficult child (e.g., "I feel that my child is very moody and easily upset"). Items are summed to create a total score for parenting stress as well as for each subscale.	Change from baseline at 7 months and at 19 months
Secondary	Change in levels of parental depression	The Depression, Anxiety, and Stress Scale (DASS) will assess caregiver depression. The DASS is a 21-item scale used as a screening tool to measure depression, anxiety, and stress in adults. Caregivers report on the frequency of depressive symptoms in the previous week using a Likert scale (0 = Never, 1 = Sometimes, 2 = Often, 3 = Always; e.g., "I felt that I had nothing to look forward to"). Total DASS scores range from 0 to 63 with subscales from 0 to 21. Recommended cut-offs indicating severity of depression are 5-6 for mild, 7-10 for moderate, 11-13 for severe, and 14 and up for extremely severe. Cut-offs for anxiety are 4-5 for mild, 6-7 for moderate, 8-9 for severe, and 10 and up for extremely severe. Cut-offs for stress are 8-9 for mild, 10-12 for moderate, 13-16 for severe, and 17 and up for extremely severe.	Change from baseline at 7 months and at 19 months
Secondary	Change in levels of parental wellbeing	The WHO-5 Well-Being Scale (WHO-5) will measure parental psychological well-being [10]. This 5-item scale was derived using psychometric analyses from the longer 28-item WHO Well-Being Scale. The validation study of the WHO-5 showed 93% sensitivity and 64% specificity when compared with the General Health Questionnaire and the Patient Health Questionnaire [28]. Parents indicate the frequency that they experience well-being in the past month (e.g., "My daily life has been filled with things that interest me") based on a Likert scale from 0 to 5 ("At no time" to "All of the time"). Items are added up with scores ranging from 0 to 25.	Change from baseline at 7 months and at 19 months
Secondary	Change in levels of parent dependency on alcohol	Parental dependency on alcohol will be assessed by asking parents to report on alcohol consumption during the past month (1 item). Dependency is based on 3 or more drinks per day for female participants and 5 or more per day for male participants [48]. Due to the sensitive nature of these items, additional items dealing with other activities to reduce stress have been included in this section to encourage accuracy (3 items; e.g., "In the past month, have you been for a walk or done some other exercise to help you relax?").	Change from baseline at 7 months and at 19 months
Secondary	Change in frequency of intimate partner violence	Adult self-report of the victimhood of intimate partner violence will be assessed using an adapted version of the Revised Conflict Tactics Scale Short Form (CTS2S; 8 items) [42]. Items include the frequency of negotiation (e.g., "partner suggested compromise to an argument"), physical assault (e.g., "partner hit me with something"), and psychological aggression (e.g., "partner insulted or swore at me"). Answers are coded on a 5-point Likert scale of 0 to 4 (0 = never happened; 4 = more than 3 times in the past month). The CTS2S will determine an overall indication of IPV on a level of severity (sum of items) and prevalence (dichotomous variable indicating experience of conflict or not) as well as for each subscale.	Change from baseline at 7 months and at 19 months
Secondary	Change in levels of marital satisfaction	Adult report of marital satisfaction will be assessed using the Kansas Marital Satisfaction Scale (KMSS; 3 items) {Schumm, 1986 #3905}. The KMSS was developed as a validated but brief measurement of marital relations. Items include satisfaction with marriage, spouse or partner, and quality of the relationship with a spouse/partner. Responses options are coded on a 7-point Likert scale of 1 to 7 (1 = extremely dissatisfied; 7 = extremely satisfied). Total scores are created by summing the items. The KMSS has been found to correlate strongly with other measures relationship adjustment and quality of marriage, and showed strong internal reliability in the feasibility pilot of the MaPa programme (a = .89).	Change from baseline at 7 months and at 19 months
Secondary	Change in levels of parent/child sleep	Parent/child sleep will be assessed by asking parents to report average daily number of hours the parent and child slept in the previous five days. In order to increase the accuracy of self-report data, research assistants will ask the parent to report on the hours of sleep for each day including hours that the child sleeps during the day. Mean score for hours slept for both parent and child will be calculated summing each day and then dividing by the number of days (i.e., 5 days).	Change from baseline at 7 months and at 19 months