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Child DevelopmentNCT07213102

Transform + Family Academy Randomized Controlled Trial in the Philippines

A study testing Integrated Whole-Household Programming and Standard Child-Focused Programming in people with Child Development and Child Nutrition, Child Neurobehavioral Development, run by International Care Ministries, Philippines.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study evaluates the integration of two complementary poverty alleviation programs: Compassion International's (CI) child-focused Survival and Early Childhood Program with International Care Ministries' (ICM) household-level Transform + Family Academy intervention. Read more about this study

Who is it for?
Ages 3 to 5 years
What is being tested?
Integrated Whole-Household Programming and Standard Child-Focused Programming
Could I receive a placebo?
No, everyone receives an active treatment
How many people
700 participants
Where
No sites listed yet
Study dates
1 Nov 2025to 30 May 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 5 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Households must have a child between 3 to 5 years old who is currently registered in CI's Survival and Early Childhood Program.
  • Households must meet ICM's poverty criteria with a poverty score of 50 and above as determined through asset-based scoring and household income evaluation. Higher scores indicate poorer households.
  • Each participating household must include an adult family member aged 18 to 65 years who serves as a primary caregiver for the target child.

Who cannot join

  • Households with previous participation in ICM's Transform program will be excluded from the study.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Lincoln L Lau, PhD contact

647-852-0288

LLau@us.ci.org

Daryn J Go, MSc contact

+63 9175211103

daryn.go@caremin.com

About this study

Official title: Integration of Household-Based Interventions With Early Childhood Programming: A Randomized Controlled Trial in the Philippines

This study evaluates the integration of two complementary poverty alleviation programs: Compassion International's (CI) child-focused Survival and Early Childhood Program with International Care Ministries' (ICM) household-level Transform + Family Academy intervention. CI's program provides holistic child development through health support, educational programming, social development, and spiritual formation via local church partners for children aged 3-5 years. ICM's Transform + Family Academy combines a 15-week household intervention targeting health education, livelihood training, and values formation with an 8-week early childhood education component delivered through home visits.

The primary aim of this research is to assess whether integrating household-level interventions with child-focused programming enhances early numeracy and literacy outcomes among children aged 3-5 living in extreme poverty in Western and Southern Mindanao, Philippines. The study also examines the intervention's impact on children's nutritional status and household financial resilience, including savings behaviors and access to social safety nets.

The investigators hypothesize that addressing household-level constraints including caregiver capacity, health, and economic challenges will enhance children's academic and nutritional outcomes alongside household financial resilience compared to child-focused programming alone.

Read the detailed description

This individual-level randomized controlled trial examines the integration of Compassion International's (CI) child-focused Survival and Early Childhood Program with International Care Ministries' (ICM) household-level Transform + Family Academy intervention among 700 families with children aged 3-5 years across CI's partner communities in Western and Southern Mindanao, Philippines. All participating households are currently registered in CI's Survival and Early Childhood Program, which provides comprehensive child development support through local community partners. Through random assignment, half of the households will additionally receive ICM's household-level intervention targeting the broader family system.

This study examines whether combining ICM's household-level interventions with CI's child-focused programming can improve developmental outcomes for children aged 3-5 years in extreme poverty settings. The research evaluates the effectiveness of ICM's Transform + Family Academy approach to addressing broader family constraints, including caregiver capacity, health challenges, and economic instability, on children's developmental outcomes and household financial resilience when integrated with CI's Survival and Early Childhood Program. Specifically, the outcomes of interest include children's early numeracy and literacy development, alongside secondary outcomes of children's nutritional status and household financial resilience as measured through savings behaviors and social safety net access.

The hypothesis underlying this work suggests that child development programs may achieve greater impact when paired with comprehensive household support that tackles the multidimensional nature of poverty affecting both immediate child needs and the family systems that sustain long-term progress.

ICM's Transform component is a 15-week program delivered through weekly 90-minute community-based group sessions covering three domains: health education (malnutrition prevention, sanitation, respiratory infections, infant care), livelihood training (income diversification, business development, savings group formation), and values formation (personal character, family relationships, decision-making). Health and livelihood sessions are facilitated by trained ICM staff, while optional values components are delivered by community leaders.

The Family Academy component provides 8 weeks of home-based early childhood education through twice-weekly visits delivering separate one-hour sessions for mathematics and phonics instruction. These sessions target both children aged 3-5 and their caregivers, building caregiver capacity to support school readiness through structured learning activities and educational games.

Eligible households must have a child aged 3-5 currently registered in CI's Survival and Early Childhood Program and meet ICM's poverty criteria (poverty score of 50 or above based on asset-based scoring and household income evaluation). Each household must include an adult caregiver aged 18-65 who can provide informed consent. Households with previous participation in ICM interventions are excluded. Households are individually randomly assigned to treatment groups using stratified randomization by community and regional levels to ensure balanced allocation across geographic locations.

Control households continue receiving CI's standard Survival and Early Childhood Program. Treatment households receive the integrated intervention combining CI's programming with ICM's Transform + Family Academy delivered over four months. All data collection is conducted by trained external enumerators at five timepoints: baseline, pre-Family Academy, post-Family Academy, midline (2 months post-intervention), and endline (12 months post-intervention).

The following analyses will be conducted for the research objectives to assess the impact of the integrated intervention:

Primary:

  • Linear regression models with cluster-robust standard errors will analyze differences in children's early numeracy competency composite scores between Treatment and Control groups.
  • Linear regression models with cluster-robust standard errors will analyze differences in children's phonics and literacy competency composite scores between Treatment and Control groups.

Secondary:

  • Linear regression models with cluster-robust standard errors will analyze differences in children's weight-for-height z-scores between Treatment and Control groups.
  • Logistic regression models with cluster-robust standard errors will analyze differences in probability of having household savings between Treatment and Control groups.
  • Linear regression models with cluster-robust standard errors will analyze differences in total household savings amounts between Treatment and Control groups.
  • Linear regression models with cluster-robust standard errors will analyze differences in social safety net access index scores between Treatment and Control groups.

All models will include baseline outcome measures as covariates and strata fixed effects for randomization stratification (community and regional levels). Analyses will be conducted separately for short-term effects (1 week after intervention and 2-month follow-up) and sustained effects at 12-month follow-up.

Being tested
Integrated Whole-Household Programming, Standard Child-Focused Programming
Keywords
Child Development, Child Nutritional Status, Household Financial Resilience

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Integrated Whole-Household ProgrammingOther

    Also called Whole-household poverty intervention

    Treatment participants receive both Compassion International's Survival and Early Childhood Program (holistic child development through health support, educational programming, social development, and spiritual formation via local community partners) plus International Care Ministries' Transform + Family Academy intervention. The Transform component is a 15-week household-level program including health education covering malnutrition prevention, sanitation, respiratory infections, infant care; livelihood training focused on income diversification and business development with savings group formation; and values formation addressing personal character, family relationships, and decision-making. The Family Academy component provides home-based early numeracy and phonics instruction (one hour per topic) to children aged 3-5 with concurrent caregiver capacity building for school readiness support, delivered over 8 weeks.

  • Standard Child-Focused ProgrammingOther

    Compassion International's Survival and Early Childhood Program provides holistic child development through health support, nutritional assistance, educational programming, social development, and spiritual formation delivered via local community partners.

Study groups in NCT07213102
Study groupRoleWhat they receive
Treatment receiving integrated Survival and Early Childhood Program & Transform + Family AcademyExperimentalTreatment: Participants will continue receiving Compassion International's Survival and Early Childhood Program and additionally receive International Care Ministries' Transform + Family Academy program. In the treatment arm, the integrated intervention will be delivered over 4 months with participants continuing to receive the Survival and Early Childhood Program. In addition to this, participants receive Transform + Family Academy, with 15 Transform sessions conducted weekly at community locations and 8 weeks of Family Academy sessions delivered through home visits. Each Transform session includes 90-minute health and livelihood training by ICM staff, with optional values components facilitated by community leaders. Family Academy provides home-based early numeracy and phonics lessons for children and their caregivers.
Receives: Other: Integrated Whole-Household Programming
Control receiving standard Survival and Early Childhood ProgramActive comparatorControl: Participants will continue receiving Compassion International's Survival and Early Childhood Program without additional interventions.
Receives: Other: Standard Child-Focused Programming

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Children's early numeracy competency at post-intervention and 12 months

    Children's early numeracy competency is assessed through proctored assessments testing early learning proficiency using eight subtasks to measure preschool children's early math skills. The assessment measures children's mathematical skills across eight components: color recognition (10 points), shape recognition (8 points), rote count (10 points), object count (10 points), numeral identification (10 points), numeral comparison (9 points), missing number (10 points), and simple addition (10 points). The total possible score is 77 points, with higher scores indicating better numeracy skills.

    Measured: Baseline, 1 week after intervention, and 12 months

  2. Children's phonics and literacy competency at post-intervention and 12 months

    Children's phonics and literacy competency is assessed through proctored assessments testing pre-reading skills and phonemic awareness. The assessment measures children's reading and phonics skills across four components: alphabet recitation (10 points), letter name identification (20 points), beginning sound recognition (20 points), and letter sound identification (20 points). The total possible score is 70 points, with higher scores indicating better literacy and phonics skills.

    Measured: Baseline, 1 week after intervention, and 12 months

Secondary outcomes (3)
  1. Children's malnutrition status at 2 months and 12 months

    Children's malnutrition status is evaluated through anthropometric measurements where weight-for-height ratios are transformed into standardized z-scores based on World Health Organization reference standards for pediatric populations. Malnutrition in children under 5 years is defined as weight-for-height z-scores below -2 standard deviations in the absence of edema.

    Measured: Baseline, 2 months, and 12 months

  2. Household savings at 2 months and 12 months

    The household savings measure assesses household financial resources through two indicators: the probability of having savings (binary measure where 0=no savings, 1=has savings) and total household savings amount. This measure evaluates household financial resilience and household capacity to accumulate and maintain financial reserves. Higher values indicate improved wealth accumulation and financial security.

    Measured: Baseline, 2 months, and 12 months

  3. Social safety net access at 2 months and 12 months

    Social safety net access is measured as a composite index assessing access to emergency financial support outside immediate household and close relatives. The index evaluates participants' ability to access 40 Philippine Pesos and 1,000 Philippine Pesos in emergency situations from extended social networks. The index is constructed using standardized methodology following Kling, Liebman, and Katz (2007), normalizing individual components against the control group before standardizing the aggregate measure. Higher scores indicate greater access to financial support networks.

    Measured: Baseline, 2 months, and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2025
  2. Study start1 Nov 2025 (estimated)
  3. Primary completion30 May 2027 (estimated)
  4. Study completion30 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study is an individual-level randomized controlled trial. A total of 700 households with children aged 3-5 years from Compassion International communities across Western and Southern Mindanao will be randomly assigned to one of two treatment arms: Treatment and Control. The treatment will be assigned at the household level, with community-level and regional-level stratification, to ensure balanced representation across geographic locations. Control households will continue receiving Compassion International's Survival and Early Childhood Program. Treatment households will receive an integrated intervention combining Compassion International's Survival and Early Childhood Program with International Care Ministries' Transform + Family Academy program. A roster of eligible households will be compiled and randomly allocated to one of two treatment arms. To minimize bias, participant recruitment and enrollment will occur prior to random treatment assignment.
Masking
None (open label)
Enrolment
700 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07213102
Sponsor's protocol ID
icmcompassionrct
Other IDs
icmcompassionrct
Status last verified
Oct 2025
First submitted
25 Sep 2025
Last updated
8 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: We are currently evaluating the feasibility of sharing individual participant data. Considerations include ethical approvals, participant consent, and the ability to sufficiently anonymize sensitive information. A final decision will be made in consultation with our ethics review board and institutional partners.

Publications

  • Bryan G, Choi JJ, Karlan D. Randomizing religion: the impact of Protestant evangelism on economic outcomes. The Quarterly Journal of Economics. 2021 Feb;136(1):293-380.

  • "Angrist, N., Kabay, S., Karlan, D., Lau, L., & Wong, K. (2025). Human Capital at Home: Evidence from a Randomized Evaluation in the Philippines (No. w33574). National Bureau of Economic Research.

Questions about this trial

What is this clinical trial studying?

A study testing Integrated Whole-Household Programming and Standard Child-Focused Programming in people with Child Development and Child Nutrition, Child Neurobehavioral Development, run by International Care Ministries, Philippines.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 8 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lincoln L Lau, PhD (647-852-0288, LLau@us.ci.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Children's early numeracy competency at post-intervention and 12 months (time frame: Baseline, 1 week after intervention, and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07213102, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2025.

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