Mental HealthNCT07148531
Caregiver Mental Health and Early Childhood Development in Conflict-Affected Settings
A study testing Seeds for Attachment (translated version) in people with Mental Health and Child Development, run by University of Los Andes, Columbia at 12 sites in Colombia.
Trial summary
The goal of this clinical trial is to learn if a community-based psychosocial program can improve caregivers' mental health and support the healthy development of young children in communities affected by conflict and forced displacement. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health, Child Development, Relationships, Father-Child
- What is being tested?
- Seeds for Attachment (translated version)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,348 participants
- Where
- 12 sitesColombia
- Study dates
- 7 Jun 2025to 30 Aug 2026
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Caregivers of children aged 0-5 residing in the 12 municipalities served by the program. These are largely municipalities affected by ongoing conflict, or reception sites of internally displaced persons or Venezuelan refugees.
Who cannot join
- Caregivers exhibiting clinical symptoms of mental health problems. These are refered to clinical mental services.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Colombia12 sites
Semillas de Apego
Barranquilla, Atlántico
Semillas de Apego
Bogotá, DC
Semillas de Apego
Cali, Valle del Cauca Department
Semillas de Apego
Cúcuta, Norte de Santander Department
Semillas de Apego
Jamundí, Valle del Cauca Department
Semillas de Apego
Los Patios, Norte de Santander Department
Semillas de Apego
Malambo, Atlántico
Semillas de Apego
Medellín, Antioquia
Semillas de Apego
Montería, Departamento de Córdoba
Semillas de Apego
Soledad, Atlántico
Semillas de Apego
Tumaco, Departamento de Nariño
Semillas de Apego
Villa del Rosario, Norte de Santander Department
About this study
Official title: Caregiver Mental Health and Early Childhood Development in Conflict-Affected Settings: A National-Scale RCT of Semillas de Apego in Colombia
The goal of this clinical trial is to learn if a community-based psychosocial program can improve caregivers' mental health and support the healthy development of young children in communities affected by conflict and forced displacement. The main questions it aims to answer are:
- Does the at-scale implementation of the program improve caregivers' mental health?
- Does improving caregivers' mental health improve the quality of the child-caregiver relationship and early childhood (socioemotional) development?
Read more
Researchers will compare caregivers who receive the program this year with those scheduled to receive it the following year to see if there are differences in caregiver mental health, the quality and style of the child-caregiver relationship, and child development outcomes.
Participants will:
- Join a 15-week group program led by trained community facilitators
- Take part in activities to build emotional regulation skills, strengthen caregiver-child relationships, encourage responsive caregiving, and expand social support networks
Read the detailed description
This project evaluates the scale-up of a community-based psychosocial program designed to restore caregiver mental health and protect early childhood development in conflict-affected and displaced communities. The program promotes caregiver mental health as an outcome and as a pathway towards protecting young children in conflict-affected settings.
Young children and their caregivers in conflict-affected and displaced communities remain one of the most underserved groups in global health and development and are disproportionately exposed to trauma and adversity. While the long-term consequences of early adversity are well established, especially for children under five, few interventions have focused on addressing the immediate and interrelated needs of caregivers and young children in humanitarian settings. This gap is especially acute in programs that integrate caregiver mental health and child development, even though a large body of research shows that children's outcomes are deeply shaped by caregivers' mental health and their capacity to provide nurturing, sensitive care.
The program to be evaluated addresses this gap by treating caregiver mental health not only as an outcome, but as a mechanism to protect early childhood development. The intervention moves beyond psychoeducational models by creating a relational and reflective space led by trained community facilitators. These facilitators-caregivers themselves-draw on shared experiences to foster a relatable, stigma-free environment. This approach directly counters stigma, builds trust, and supports participation in settings where mental health services are limited and where there are also demand-side constraints for accessing these services.
The program is implemented through a 15-week group-based model with approximately 15 caregivers per group. The program follows four sequential goals: (1) promoting awareness of and tools for emotional regulation of the psychological consequences of conflict and forced displacement; (2) understanding children's emotional needs and the caregiver-child relationship; (3) developing responsive caregiving practices that foster secure attachment; and (4) strengthening social support networks. The approach integrates psychosocial support with attention to the social determinants of caregiving and mental health.
The program has undergone four stages of evaluation: a pilot study, a randomized controlled trial in one conflict-affected municipality, an at-scale pilot in four municipalities, and a mixed-methods evaluation of the added impact of integrating digital videos for socioemotional learning (developed by Sesame Workshop) on top of the standard program. Building on this evidence, this trial will evaluate the national scale-up, which reaches over 4,200 caregivers annually across 12 municipalities in partnership with local governments and community organizations. Using a phase-in randomized design to ensure an ethical approach, we will assess whether the program's positive effects and cost-effectiveness, as documented in the earlier RCT, are preserved when implemented at scale and across more heterogeneous populations, including victims of armed conflict, internally displaced persons, and Venezuelan refugees.
Findings will inform the potential and scalability of community-based psychosocial models in humanitarian settings and shed light on the importance of targeting caregiver mental health and early childhood development within a unified lens to prevent the intergenerational transmission of trauma and poverty.
- Being tested
- Seeds for Attachment (translated version)
- Keywords
- Caregiver Mental Health, Early Childhood Development, Conflict-Affected Populations, Refugees, IDPs, Community Psychosocial Model, Colombia
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seeds for Attachment (translated version)Behavioural
Developed by, and base at Universidad de los Andes, this is a community-based psychosocial model for caregivers of young children in conflict-affected settings.
The program is implemented through a 15-week group-based model with approximately 15 caregivers per group, and led by community facilitators (non-professionals).
The program follows four sequential goals: (1) promoting awareness of and tools for emotional regulation of the psychological consequences of conflict and forced displacement; (2) understanding children's emotional needs and the caregiver-child relationship; (3) developing responsive caregiving practices that foster secure attachment; and (4) strengthening social support networks. The approach integrates psychosocial support with attention to the social determinants of caregiving and mental health.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm - Early Intervention Group | Experimental | Participants assigned to this arm will have the opportunity to participate in the community-based psychosocial program in the second semester of 2025-2, following a wait-list design. This will be the early-treatment group. Receives: Behavioral: Seeds for Attachment (translated version) |
| Control Arm: Wait List / Later Treatment Group | Experimental | Participants assigned to this arm will have the opportunity to participate in the community-based psychosocial program in the second semester of 2026-2, after all data collection has been completed. Following a wait-list design, this will be the control or late-treatment group. Receives: Behavioral: Seeds for Attachment (translated version) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caregiver Mental Health
Mental Health index constructed following a latent-factor analysis as in Kling et al. (2007) using data from an instrument based on the adapted SCL-90-R, measuring anxiety, depression, phobic anxiety, sensitivity, and hostility.
Measured: From enrollment to the end of treatment at 1 and 8-month post-intervention follow-ups
Quality of the child-caregiver relationship
Relationship index constructed following a latent-factor analysis as in Kling et al. (2007) using data from the Parenting Stress Index (short form).
Measured: From enrollment to the end of treatment at 1 and 8-month post-intervention follow-ups
Quality of the child-caregiver relationship
Child-Parent Relationship Scale (CPRS)
Measured: From enrollment to the end of treatment at 1 and 8-month post-intervention follow-ups
Quality of the child-caregiver relationship
Adapted version of the Observation of Mother-Child Interactions (OMCI) administered at the second follow-up only, 8 months post-intervention.
Measured: 8-month post-intervention follow-up
Style of the child-caregiver relationship
Index of style of the child-caregiver interactions constructed following a latent-factor analysis as in Kling et al. (2007) using data from the Parent Behavior Checklist.
Measured: Time Frame: From enrollment to the end of treatment at 1 and 8-month post-intervention follow-ups
Early childhood development (socioemotional)
Brief Toddler Socioemotional Assessment (BITSEA, (Briggs-Gowan et al., 2004)), a caregiver-reported scale that evaluates children's social-emotional development, including behavioral problems, developmental delays, and deficits in social-emotional competence.
Measured: From enrollment to the end of treatment at 1 and 8-month post-intervention follow-ups
Early childhood development (socioemotional)
International Development Early Learning Assessment (IDELA), designed for children aged 3 to 6, assesses five developmental areas: motor skills, emergent literacy, emergent numeracy, social-emotional development, and executive functions. We will focus on social-emotional development and executive functions.
Conditional on children's ages at the second follow-up, we will complement these measures with additional caregiver-reported scales such as the SDQ.
Measured: 8-month post-intervention follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start7 Jun 2025
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,348 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Los Andes, Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Conrad N. Hilton Foundation
- Responsible party
- Principal investigator, Andres Moya, University of Los Andes, Columbia
- Investigators
- Andres Moya., PhD, Principal investigator, Economics. Universidad de los Andes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07148531
- Sponsor's protocol ID
- 8-2025
- Status last verified
- Aug 2025
- First submitted
- 12 Aug 2025
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized data for replication
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caregiver Mental Health and Early Childhood Development in Conflict-Affected Settings: A National-Scale RCT of Semillas de Apego in Colombia
- ClinicalTrials.gov ID
- NCT07148531
- Acronym / sponsor ID
- 8-2025
- Keywords
- Caregiver Mental Health, Early Childhood Development, Conflict-Affected Populations, Refugees, IDPs, Community Psychosocial Model, Colombia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,348 participants (actual)
- Lead sponsor
- University of Los Andes, ColumbiaUniversity, hospital or other
- Collaborators
- Conrad N. Hilton Foundation
- Study start
- 7 Jun 2025 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 29 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if a community-based psychosocial program can improve caregivers' mental health and support the healthy development of young children in communities affected by conflict and forced displacement. The main questions it aims to answer are:
- Does the at-scale implementation of the program improve caregivers' mental health?
- Does improving caregivers' mental health improve the quality of the child-caregiver relationship and early childhood (socioemotional) development?
Researchers will compare caregivers who receive the program this year with those scheduled to receive it the following year to see if there are differences in caregiver mental health, the quality and style of the child-caregiver relationship, and child development outcomes.
Participants will:
- Join a 15-week group program led by trained community facilitators
- Take part in activities to build emotional regulation skills, strengthen caregiver-child relationships, encourage responsive caregiving, and expand social support networks
Detailed description
This project evaluates the scale-up of a community-based psychosocial program designed to restore caregiver mental health and protect early childhood development in conflict-affected and displaced communities. The program promotes caregiver mental health as an outcome and as a pathway towards protecting young children in conflict-affected settings.
Young children and their caregivers in conflict-affected and displaced communities remain one of the most underserved groups in global health and development and are disproportionately exposed to trauma and adversity. While the long-term consequences of early adversity are well established, especially for children under five, few interventions have focused on addressing the immediate and interrelated needs of caregivers and young children in humanitarian settings. This gap is especially acute in programs that integrate caregiver mental health and child development, even though a large body of research shows that children's outcomes are deeply shaped by caregivers' mental health and their capacity to provide nurturing, sensitive care.
The program to be evaluated addresses this gap by treating caregiver mental health not only as an outcome, but as a mechanism to protect early childhood development. The intervention moves beyond psychoeducational models by creating a relational and reflective space led by trained community facilitators. These facilitators-caregivers themselves-draw on shared experiences to foster a relatable, stigma-free environment. This approach directly counters stigma, builds trust, and supports participation in settings where mental health services are limited and where there are also demand-side constraints for accessing these services.
The program is implemented through a 15-week group-based model with approximately 15 caregivers per group. The program follows four sequential goals: (1) promoting awareness of and tools for emotional regulation of the psychological consequences of conflict and forced displacement; (2) understanding children's emotional needs and the caregiver-child relationship; (3) developing responsive caregiving practices that foster secure attachment; and (4) strengthening social support networks. The approach integrates psychosocial support with attention to the social determinants of caregiving and mental health.
The program has undergone four stages of evaluation: a pilot study, a randomized controlled trial in one conflict-affected municipality, an at-scale pilot in four municipalities, and a mixed-methods evaluation of the added impact of integrating digital videos for socioemotional learning (developed by Sesame Workshop) on top of the standard program. Building on this evidence, this trial will evaluate the national scale-up, which reaches over 4,200 caregivers annually across 12 municipalities in partnership with local governments and community organizations. Using a phase-in randomized design to ensure an ethical approach, we will assess whether the program's positive effects and cost-effectiveness, as documented in the earlier RCT, are preserved when implemented at scale and across more heterogeneous populations, including victims of armed conflict, internally displaced persons, and Venezuelan refugees.
Findings will inform the potential and scalability of community-based psychosocial models in humanitarian settings and shed light on the importance of targeting caregiver mental health and early childhood development within a unified lens to prevent the intergenerational transmission of trauma and poverty.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm - Early Intervention Group | Experimental | Behavioral: Seeds for Attachment (translated version)Participants assigned to this arm will have the opportunity to participate in the community-based psychosocial program in the second semester of 2025-2, following a wait-list design. This will be the early-treatment group. |
| Control Arm: Wait List / Later Treatment Group | Experimental | Behavioral: Seeds for Attachment (translated version)Participants assigned to this arm will have the opportunity to participate in the community-based psychosocial program in the second semester of 2026-2, after all data collection has been completed. Following a wait-list design, this will be the control or late-treatment group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Caregivers of children aged 0-5 residing in the 12 municipalities served by the program. These are largely municipalities affected by ongoing conflict, or reception sites of internally displaced persons or Venezuelan refugees.
Key exclusion criteria (1 listed)
- Caregivers exhibiting clinical symptoms of mental health problems. These are refered to clinical mental services.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Seeds for Attachment (translated version)Developed by, and base at Universidad de los Andes, this is a community-based psychosocial model for caregivers of young children in conflict-affected settings. The program is implemented through a 15-week group-based model with approximately 15 caregivers per group, and led by community facilitators (non-professionals). The program follows four sequential goals: (1) promoting awareness of and tools for emotional regulation of the psychological consequences of conflict and forced displacement; (2) understanding children's emotional needs and the caregiver-child relationship; (3) developing responsive caregiving practices that foster secure attachment; and (4) strengthening social support networks. The approach integrates psychosocial support with attention to the social determinants of caregiving and mental health. | Behavioural | Control Arm: Wait List / Later Treatment Group, Treatment Arm - Early Intervention Group |
Primary outcome
Caregiver Mental Health
Time frame: From enrollment to the end of treatment at 1 and 8-month post-intervention follow-ups
Mental Health index constructed following a latent-factor analysis as in Kling et al. (2007) using data from an instrument based on the adapted SCL-90-R, measuring anxiety, depression, phobic anxiety, sensitivity, and hostility.
Quality of the child-caregiver relationship
Time frame: From enrollment to the end of treatment at 1 and 8-month post-intervention follow-ups
Relationship index constructed following a latent-factor analysis as in Kling et al. (2007) using data from the Parenting Stress Index (short form).
Quality of the child-caregiver relationship
Time frame: From enrollment to the end of treatment at 1 and 8-month post-intervention follow-ups
Child-Parent Relationship Scale (CPRS)
Quality of the child-caregiver relationship
Time frame: 8-month post-intervention follow-up
Adapted version of the Observation of Mother-Child Interactions (OMCI) administered at the second follow-up only, 8 months post-intervention.
Style of the child-caregiver relationship
Time frame: Time Frame: From enrollment to the end of treatment at 1 and 8-month post-intervention follow-ups
Index of style of the child-caregiver interactions constructed following a latent-factor analysis as in Kling et al. (2007) using data from the Parent Behavior Checklist.
Early childhood development (socioemotional)
Time frame: From enrollment to the end of treatment at 1 and 8-month post-intervention follow-ups
Brief Toddler Socioemotional Assessment (BITSEA, (Briggs-Gowan et al., 2004)), a caregiver-reported scale that evaluates children's social-emotional development, including behavioral problems, developmental delays, and deficits in social-emotional competence.
Early childhood development (socioemotional)
Time frame: 8-month post-intervention follow-up
International Development Early Learning Assessment (IDELA), designed for children aged 3 to 6, assesses five developmental areas: motor skills, emergent literacy, emergent numeracy, social-emotional development, and executive functions. We will focus on social-emotional development and executive functions. Conditional on children's ages at the second follow-up, we will complement these measures with additional caregiver-reported scales such as the SDQ.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Individual participant dataSharing planned: Yes. Anonymized data for replication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andres Moya., PhD principal investigator
Economics. Universidad de los Andes
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Seeds for Attachment (translated version) in people with Mental Health and Child Development, run by University of Los Andes, Columbia at 12 sites in Colombia.
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 1 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: under way, not looking for participants, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caregiver Mental Health (time frame: From enrollment to the end of treatment at 1 and 8-month post-intervention follow-ups). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Aug 2025.