Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-26 @ 2:57 AM
Study NCT ID:
NCT07213102
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-08
First Post:
2025-09-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Transform + Family Academy Randomized Controlled Trial in the Philippines
Sponsor:
International Care Ministries, Philippines
Organization:
Study Overview
Official Title:
Integration of Household-Based Interventions With Early Childhood Programming: A Randomized Controlled Trial in the Philippines
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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. 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.
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| icmcompassionrct | OTHER | Compassion | View |