| Field | Before | After |
|---|---|---|
| Field Abstract | Before Over half a million children between 0 and 5 years of age in Colombia have been affected by a civil conflict that has spanned over six decades. Exposure to violence during early childhood may have devastating consequences on early childhood cognitive and socio-emotional development. The devastating effects of violence on early childhood development occur through two different and complementary channels: First, excessive stress stemming from the exposure violence and other early childhood adversities disrupts the architecture of the developing brain (NSCDC, 2005) and inhibits the appropriate functioning of the body’s stress-response system. Second, violence brings about a legacy of poverty and psychological trauma (Ibañez & Moya, 2010; Moya, 2018), which undermines the primary caregivers’ capacity to form healthy emotional bonds with their children and increases the likelihood of extreme neglect (Lieberman and Van Horn, 2011; Cuartas, Harker, & Moya, 2015). This means that children’s development is at risk even if they are not exposed to violence directly; for example, if their parents had been victimized previously. Taken together, violence can impair the development of key cognitive and socio-emotional abilities therefore compromising the right to lead healthy and productive lives for thousands of children in Colombia. Protecting children from effects of violence, toxic stress, and deficits in family care is therefore one of the key challenges as Colombia transitions into a post-conflict stage and for the construction of a more equal and peaceful society. More generally, identifying cost effective ways to guarantee children’s cognitive and socioemotional development is a key challenge in contexts of violence and humanitarian crises around the world. In this trial, we evaluate the effectiveness of Semillas de Apego, a group-based psychosocial program for victimized caregivers with children 2 to 5 in Colombia, a country devastated by decades of civil violence. The program builds upon recent evidence on the positive effects of different interventions that limit the harmful consequences of childhood stress in the United States through the promotion of maternal mental health and healthy child-parent emotional bonds (Lieberman & Van Horn, 2011; Singla, Kumbakumba, & Aboud, 2015; Rahman et al., 2013). Together, this evidence suggests a promising path to protect early childhood development in contexts of extreme adversity through the attention to their caregivers. Semillas de Apego seeks to promote healthy child-parent attachments as a pathway for a proper development among children exposed to violence. By fostering caregivers’ mental health and their capacity to become a source of emotional protection, the intervention helps children reach their full potential amid such traumatic circumstances. Delivered over 15 weekly group sessions, program first provides tools so that victimized caregivers can start processing their own trauma. Then, the program focuses on allowing a proper understanding of the child’s development trajectories and how they affected by the experience of adversities (such as violence exposure). Finally, it aims to foster positive child-rearing practices. Taken together, Semillas de Apego’s curriculum seeks to promote maternal mental health and the healthy child-parent attachments that translate into appropriate affect regulation and healthy emotional development in the midst of adverse circumstances. The current trial will be conducted in Tumaco, a municipality in Colombia heavily affected by violence and poverty. Over a time-span of 23 months, we will follow the implementation of Semillas de Apego with 40 groups of 16 participants each, all of them mothers or primary caregivers of children 2 to 5. This will allow us to reach a total of 640 participants and their children. The impact evaluation will be based on a cluster- randomized control trial in which we will assign eligible subjects, nested within 18 child development centers, to either an intervention arm or a control group. The former group will participate in 15 group-led session over the period of 3 months; the latter will continue to have access to the regular early childhood programs offered through the centers to which children are affiliated. Data will be collected at baseline and two follow-ups: 1 and 12 months after the implementation has concluded. We hypothesize that the program will have a positive and sequential impact on the following dimensions: (i) primary caregiver’s mental health, (ii) child rearing practices, (iii) quality of child-parent emotional bond, (iv) children’s mental health, and (v) children’s cognitive and socioemotional development. | After Over half a million children between 0 and 5 years of age in Colombia have been affected by a civil conflict that has spanned over six decades. Exposure to violence during early childhood may have devastating consequences on early childhood cognitive and socio-emotional development. The devastating effects of violence on early childhood development occur through two different and complementary channels: First, excessive stress stemming from the exposure violence and other early childhood adversities disrupts the architecture of the developing brain (NSCDC, 2005) and inhibits the appropriate functioning of the body’s stress-response system. Second, violence brings about a legacy of poverty and psychological trauma (Ibañez & Moya, 2010; Moya, 2018), which undermines the primary caregivers’ capacity to form healthy emotional bonds with their children and increases the likelihood of extreme neglect (Lieberman and Van Horn, 2011; Cuartas, Harker, & Moya, 2015). This means that children’s development is at risk even if they are not exposed to violence directly; for example, if their parents had been victimized previously. Taken together, violence can impair the development of key cognitive and socio-emotional abilities therefore compromising the right to lead healthy and productive lives for thousands of children in Colombia. Protecting children from effects of violence, toxic stress, and deficits in family care is therefore one of the key challenges as Colombia transitions into a post-conflict stage and for the construction of a more equal and peaceful society. More generally, identifying cost effective ways to guarantee children’s cognitive and socioemotional development is a key challenge in contexts of violence and humanitarian crises around the world. In this trial, we evaluate the effectiveness of Semillas de Apego, a group-based psychosocial program for victimized caregivers with children 2 to 5 in Colombia, a country devastated by decades of civil violence. The program builds upon recent evidence on the positive effects of different interventions that limit the harmful consequences of childhood stress in the United States through the promotion of maternal mental health and healthy child-parent emotional bonds (Lieberman & Van Horn, 2011; Singla, Kumbakumba, & Aboud, 2015; Rahman et al., 2013). Together, this evidence suggests a promising path to protect early childhood development in contexts of extreme adversity through the attention to their caregivers. Semillas de Apego seeks to promote healthy child-parent attachments as a pathway for a proper development among children exposed to violence. By fostering caregivers’ mental health and their capacity to become a source of emotional protection, the intervention helps children reach their full potential amid such traumatic circumstances. Delivered over 15 weekly group sessions, program first provides tools so that victimized caregivers can start processing their own trauma. Then, the program focuses on allowing a proper understanding of the child’s development trajectories and how they affected by the experience of adversities (such as violence exposure). Finally, it aims to foster positive child-rearing practices. Taken together, Semillas de Apego’s curriculum seeks to promote maternal mental health and the healthy child-parent attachments that translate into appropriate affect regulation and healthy emotional development in the midst of adverse circumstances. The current trial will be conducted in Tumaco, a municipality in Colombia heavily affected by violence and poverty. Over a time-span of 23 months, we will follow the implementation of Semillas de Apego with 40 groups of 16 participants each, all of them mothers or primary caregivers of children 2 to 5. This will allow us to reach a total of 640 participants and their children. The impact evaluation will be based on a cluster- randomized control trial in which we will assign eligible subjects, nested within 18 child development centers, to either an intervention arm or a control group. The former group will participate in 15 group-led session over the period of 3 months; the latter will continue to have access to the regular early childhood programs offered through the centers to which children are affiliated. Data will be collected at baseline and two follow-ups: 1 and 12 months after the implementation has concluded. We hypothesize that the program will have a positive and sequential impact on the following dimensions: (i) primary caregiver’s mental health, (ii) child rearing practices, (iii) quality of child-parent emotional bond, (iv) children’s mental health, and (v) children’s cognitive and socioemotional development. |
| Field Last Published | Before April 11, 2018 12:02 PM | After April 20, 2020 05:53 PM |
| Field Experimental Design (Public) | Before The experimental evaluation of Semillas de Apego will be conducted as a Cluster-Randomized Control Trial (C-RCT). The eligible population for the study are all families served by Genesis Foundation’s ECDC in Tumaco, Colombia and whose children’s ages range between 2 to 4 years of age. For example, for the first cohort, the children should have been born between August 1st, 2014 to April 1st, 2016. Random assignment to the treatment will be conducted at the ECDC level (n=19). We eliminated one of these EDCD because it did not provide the infrastructure required to run the group sessions – a private space. However, this center is not different than the other 18 ECDC over a range of observable characteristics. Out of the remaining 18 EDCD, we conducted a random assignment based on the ECD’s size, age-range, gender and anthropometrics of eligible children, the size of the center, and a composite socio-economic status score. In doing so, 9 ECDC to were selected to run the implementation, while the other 9 remaining centers were assigned to the control arm. Within each center assigned to the treatment arm in each cohort, the total number of families invited to participate in the program, and the number of intervention groups, will be based on the number of children served by the center relative to the total number of children served by the 18 EDCD in Tumaco. Then, we will distribute the treated ECDC and intervention groups across the 4 cohorts, ensuring that each ECDC has at least one intervention group per year. Hence, larger ECDC in the treatment arm will have one or more intervention groups in each of the 4 cohorts, whereas the smaller ECDC will have at least one intervention group in 2018 and another one in 2019. For each treated ECDC in each cohort, we will randomly order eligible subjects within each center to be invited to participate in the intervention and invite then to participate according to this ordered list. Invitations will be carried out by the team of six social workers starting three weeks prior to the start of the intervention. Eligible subjects will be contacted at the EDCD or by phone and will be informed of the objectives and structure of the program, the schedule of the group sessions, and the potential benefits, including small incentives (super market cash cards or other incentives for up to US$8) for completing each phase of the data collection. Eligible subjects will also be informed that their decision to participate or not in Semillas de Apego and the data collection does not have any consequence on access to Genesis Foundation’s programs in the municipality, including their children’s access to the ECDC, or their participation in standard community groups and activities. Once eligible subjects accept to participate, they will be contacted by the data collection firm, which will coordinate the date and time of the baseline data collection. We will follow a similar strategy in the EDCD assigned to the control arm. We will first calculate the number of families that were invited to participate in the program based on the number of children served by the center relative to the total number of children served by the 18 EDCD in Tumaco. Then, we will distribute the ECDC across the 4 cohorts, ensuring that in each ECDC we assemble control groups at least once per year. Hence, larger ECDC in the control arm will have one or more control groups in each of the 4 cohorts, whereas the smaller ECDC will have at least one control group in 2018 and another one in 2019. Then, we will randomly order eligible subjects within each center to be invited to participate in the different phases of data collection. Invitations will be carried out by the data collection team three weeks prior to the start of the intervention. Eligible subjects will be contacted at the EDCD or by phone and will be informed of the objectives and structure of the data collection and the potential benefits, including small incentives (super market cash cards for up to US$8) for completing the data collection. Eligible subjects will also be informed that their decision to participate in the data collection does not have any consequence on access to Genesis Foundation’s programs in the municipality, including their children’s access to the ECDC, or their participation in standard community groups and activities. All randomization procedures will be conducted using the RANDOMIZE module (Kennedy & Mann, 2015), available in Stata 15. In doing so, we achieve balance on key characteristics at each phase of the randomization procedure. | After The experimental evaluation of Semillas de Apego will be conducted as a Cluster-Randomized Control Trial (C-RCT). The eligible population for the study are all families served by Genesis Foundation’s ECDC in Tumaco, Colombia and whose children’s ages range between 2 to 4 years of age. For example, for the first cohort, the children should have been born between August 1st, 2014 to April 1st, 2016. Random assignment to the treatment will be conducted at the ECDC level (n=19). We eliminated one of these EDCD because it did not provide the infrastructure required to run the group sessions – a private space. However, this center is not different than the other 18 ECDC over a range of observable characteristics. Out of the remaining 18 EDCD, we conducted a random assignment based on the ECD’s size, age-range, gender and anthropometrics of eligible children, the size of the center, and a composite socio-economic status score. In doing so, 9 ECDC to were selected to run the implementation, while the other 9 remaining centers were assigned to the control arm. Within each center assigned to the treatment arm in each cohort, the total number of families invited to participate in the program, and the number of intervention groups, will be based on the number of children served by the center relative to the total number of children served by the 18 EDCD in Tumaco. Then, we will distribute the treated ECDC and intervention groups across the 4 cohorts, ensuring that each ECDC has at least one intervention group per year. Hence, larger ECDC in the treatment arm will have one or more intervention groups in each of the 4 cohorts, whereas the smaller ECDC will have at least one intervention group in 2018 and another one in 2019. For each treated ECDC in each cohort, we will randomly order eligible subjects within each center to be invited to participate in the intervention and invite then to participate according to this ordered list. Invitations will be carried out by the team of six social workers starting three weeks prior to the start of the intervention. Eligible subjects will be contacted at the EDCD or by phone and will be informed of the objectives and structure of the program, the schedule of the group sessions, and the potential benefits, including small incentives (super market cash cards or other incentives for up to US$8) for completing each phase of the data collection. Eligible subjects will also be informed that their decision to participate or not in Semillas de Apego and the data collection does not have any consequence on access to Genesis Foundation’s programs in the municipality, including their children’s access to the ECDC, or their participation in standard community groups and activities. Once eligible subjects accept to participate, they will be contacted by the data collection firm, which will coordinate the date and time of the baseline data collection. We will follow a similar strategy in the EDCD assigned to the control arm. We will first calculate the number of families that were invited to participate in the program based on the number of children served by the center relative to the total number of children served by the 18 EDCD in Tumaco. Then, we will distribute the ECDC across the 4 cohorts, ensuring that in each ECDC we assemble control groups at least once per year. Hence, larger ECDC in the control arm will have one or more control groups in each of the 4 cohorts, whereas the smaller ECDC will have at least one control group in 2018 and another one in 2019. Then, we will randomly order eligible subjects within each center to be invited to participate in the different phases of data collection. Invitations will be carried out by the data collection team three weeks prior to the start of the intervention. Eligible subjects will be contacted at the EDCD or by phone and will be informed of the objectives and structure of the data collection and the potential benefits, including small incentives (super market cash cards for up to US$8) for completing the data collection. Eligible subjects will also be informed that their decision to participate in the data collection does not have any consequence on access to Genesis Foundation’s programs in the municipality, including their children’s access to the ECDC, or their participation in standard community groups and activities. All randomization procedures will be conducted using the RANDOMIZE module (Kennedy & Mann, 2015), available in Stata 15. In doing so, we achieve balance on key characteristics at each phase of the randomization procedure. |
| Field | Before | After |
|---|---|---|
| Field Document Name | Before | After Semillas de Apego - Pre-analysis plan |
| Field Custom Type | Before | After Pre-analysis plan amendment |
| Field File | Before |
After
Semillas+de+Apego+-+Amendment+to+pre-analysis+plan.pdf
MD5:
8794c0d0b56ab9b88829dc2f909ea371
SHA1:
4ebab28dfcd5021626461b49b9c0254d3d0c2c2d
|
| Field Description | Before | After This note summarizes an amendment to the empirical analysis and data collection due to the COVID-19 pandemic. It applies to the following registries: * AEA Registry # 2868 * Clinical Trials Registry NCT03502252 |
| Field Public | Before | After Yes |