Heal-to-Grow

Last registered on May 24, 2023

Pre-Trial

Trial Information

General Information

Title
Heal-to-Grow
RCT ID
AEARCTR-0011050
Initial registration date
May 23, 2023

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
May 24, 2023, 4:54 PM EDT

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Locations

Region

Primary Investigator

Affiliation
Inter-American Development Bank (IDB)

Other Primary Investigator(s)

Additional Trial Information

Status
In development
Start date
2023-05-24
End date
2024-02-02
Secondary IDs
Prior work
This trial does not extend or rely on any prior RCTs.
Abstract
Heal to Grow is a strategy that seeks to promote socio-emotional development and well-being in children during early childhood (0-5 years) through group-based mindfulness and socio-emotional skills sessions with ECD workers in Colombia. To achieve this goal, the strategy promotes the socio-emotional well-being of ECD workers, emphasizing the importance of strengthening their skills to improve their interactions with children, pregnant women, and caregivers and promote socio-emotional and well-being development among these populations.

Heal-to-Grow is implemented through the Colombian Institute of Family Welfare (ICBF) through a network of Service Units (UDS) in a sample of 3 capital cities and some surrounding municipalities. UDSs are early education and care settings or home visit schemes under the responsibility of a trained person for children from 6 months to 5 years of age. All UDS under ICBF serve about 1.7 million vulnerable children and their families nationwide.

This study aims to evaluate the impact of the strategy through a randomized controlled trial (RCT). The evaluation will allow Heal to Grow to determine with greater certainty if it achieves its ultimate goal of promoting the socio-emotional development of young children and caregivers by strengthening the emotional well-being of ECD workers. This evidence will also inform whether Heal to Grow should continue a process of refinement or identify alternatives to scale the strategy so that it can cover a significant number of ECD workers at the national level.
External Link(s)

Registration Citation

Citation
Naslund-Hadley, Emma. 2023. "Heal-to-Grow ." AEA RCT Registry. May 24. https://doi.org/10.1257/rct.11050-1.0
Sponsors & Partners

Sponsors

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Experimental Details

Interventions

Intervention(s)
Heal-to-Grow is offered to Colombian ECD workers and consists of approximately 17 face-to-face sessions (approximately 120 minutes each) on socio-emotional development and mindfulness practice, supplemented by 15 virtual practice sessions (approximately 30 minutes each) and on-site facilitation (approximately 8-16 hours).
Heal-to-Grow face-to-face sessions are divided into 3 modules:
1. Emotional well-being for ECD workers: This module is about the strengthening of ECD workers' socioemotional skills through mindfulness practices.
2. Children's socioemotional strengthening: This module seeks at ways to strengthen socio-emotional development from birth and during early childhood with strategies based on mindfulness in the framework of the services provided by ECD workers at ICBF.
3. Socioemotional Family Strengthening: This module aims to provide ECD workers with tools of mindfulness as a complement to the accompaniment of families.
Intervention (Hidden)
Intervention Start Date
2023-06-05
Intervention End Date
2023-10-13

Primary Outcomes

Primary Outcomes (end points)
ECD Workers: Mindfulness skills; SEL - Social awareness, Self-awareness, Self-management/ Self-control, Relationship Skills and Responsible decision-making.
Primary Outcomes (explanation)
The outcomes of Heal to Grow surveys are categorized by the five core competencies of the CASEL framework, which stands for Collaborative for Academic, Social, and Emotional Learning. This framework provides a comprehensive approach to promoting social and emotional learning in schools and includes the following competencies: self-awareness, self-management, social awareness, relationship skills, and responsible decision-making.
To collect data on these socioemotional skills, a survey will be constructed based on the following instruments:
- Five Facets of Mindfulness Questionnaire (FFMQ)
- Test of Regulation in and Understanding of Social Situations in Teaching (TRUST)

Secondary Outcomes

Secondary Outcomes (end points)
ECD workers: Wellbeing and Stress; and Key settings influence on initial education institutions.
Children: Social awareness - Relationship Skills - Self-management - Responsible decision making.
Caregivers: Stress and well-being, self-awareness, self-management, relationship skills, and key setting influence for Families or caregivers
Secondary Outcomes (explanation)
To obtain these outcomes in ECD workers we have thought of including questions based on the following two instruments:
- Warwick-Edinburgh Mental Well-being Scale (WEMWBS).
- Teacher Subjective Wellbeing Questionnaire (TSWQ).

To obtain the outcomes in children, another questionnaire based on the following instruments would be used:
- International Development and Early Learning Assessment (IDELA).
- Escala Abreviada de Desarrollo - 3 (EAD-3) - Ministerio de Salud de Colombia.
- Strengths and Difficulties Questionnaire (SDQ).
- Ages & Stages Questionnaires: Social-Emotional section.

To obtain the outcomes in caregivers, another questionnaire based on the following instruments would be used:
- Parental Stress Scale (PSS)
- Parenting Stress Inventory Short Form (PSI-4-SF)
- Self-Compassion Scale (SCS)
- Social-Emotional Assessment/ Evaluation Measure (SEAM™), Research Edition - Caregivers Form

Experimental Design

Experimental Design
The proposed evaluation is a cluster randomized control trial (cRCT) where clusters are defined as the Units of Services (UDSs). On the recruitment phase, the objective is to receive excess demand for program enrollment: approximately 700 interested UDS in participating in Heal to Grow (in contrast to their actual implementation capacity of approximately 210 UDS). Given this excess demand, treatment randomization will be performed after the inscription stage and before the definition of the logistics of the groups; all ECD workers belonging to the same UDS will be assigned to the same group.

This group of 700 UDS will be randomly assigned into three groups: treatment, control, and replacement. The UDS selected into the treatment group will receive Heal to Grow’s training curricula, while UDS assigned to the control group will not receive any intervention. Replacement UDS will receive the training only if selected to replace a treatment UDS. Otherwise, these UDS will not receive any intervention nor be included in the study sample.

To measure the change in the socioemotional skills of ECD workers, a self-administered questionnaire based on existing tools such as the Five Facets of Mindfulness Questionnaire (FFMQ), the Test of Regulation in and Understanding of Social Situations in Teaching (TRUST) will be used, in addition to some observation tools in controlled situations. For caregivers, another self-administered questionnaire will be applied using instruments such as the Parenting Stress Inventory Short Form (PSI-4-SF). Other instruments that require direct interaction such as the International Development and Early Learning Assessment (IDELA) will be used for children. In the primary and secondary outcomes explanation section, you will find all the instruments that inspired the questionnaire.

After collecting endline information, we will estimate the impact of Heal to Grow through Intention To Treat (ITT) and Local Average Treatment Effect (LATE) estimators through an OLS regression with fixed effects and clustered standard errors at the UDS level.
Experimental Design Details
Randomization Method
Randomization done in office by a computer
Randomization Unit
Clusters: Service Units (UDSs)
Was the treatment clustered?
Yes

Experiment Characteristics

Sample size: planned number of clusters
700 Service Units expected to be recruited/interested and 426 between treatment and control groups
Sample size: planned number of observations
1800 ECD workers (1100 between treatment and control), 3.000 children/caregivers
Sample size (or number of clusters) by treatment arms
213 Service Units control, 213 Service Units treatment and 274 Service Units to Replacement group.
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
0.35 DE in the FFMQ scale for ECD workers
IRB

Institutional Review Boards (IRBs)

IRB Name
Innovations For poverty Action
IRB Approval Date
2023-04-19
IRB Approval Number
4418

Post-Trial

Post Trial Information

Study Withdrawal

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Intervention

Is the intervention completed?
No
Data Collection Complete
Data Publication

Data Publication

Is public data available?
No

Program Files

Program Files
Reports, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials