Please select the eligibility criteria that correspond to the clinical trial below.
Title: Improving Early Childhood Development in Zambia
Brief Summary: The purpose of this study is to evaluate the impact of a community-based early childhood development (ECD) program on children's physical and cognitive development. Under the program, targeted communities will be assigned a trained Child Development Agent (CDA) who will have four main tasks and responsibilities: 1) biweekly screening and management (including referral) of acute malnutrition in children; 2) encouragement of caregivers to utilize routine care services for children; 3) screening for symptoms of acute diseases including malaria, diarrhea, and pneumonia and referral for diagnosis and treatment; and 4) organization and mentoring of biweekly caregiver meetings to discuss parenting and promote early childhood cognitive stimulation. The investigators will enroll at baseline around 600 children ages 6 - 12 months and their caregivers, and randomize them at the community-level to receive the ECD program or to remain in the control group. The study period will be one year. At end line, the investigators will collect important indicators of child physical and cognitive development to assess program impact. If the program shows both feasibility and impact, there is the potential to integrate program interventions into existing national community-based health initiatives.

Amendment: the study period has been extended for a second year. After a five month gap when no intervention was provided, biweekly (i.e., fortnightly) community-based parenting groups were restarted in intervention clusters. In the second year of the intervention, CDAs no longer visit households.


Options:
A: Inclusion Criteria:

* Focus Group-User Interface/User Experience (UI/UX) Participants: Aged 18 or older; ability to attend 1-2 sessions (90 minutes per session)
* Family Participants: Families who are (a) a Sierra Leonean household with cohabitating caregivers (e.g., father/mother, mother/grandmother, mother/intimate partner), and child (aged 6-36 months) with both parents aged 18 or older and; (b) one parent scoring at least 62.5 on the Difficulties in Emotion Regulation Scale (DERS). The DERS cut-off score has been used successfully as a risk assessment screening tool in our prior and ongoing studies in Sierra Leone. Sierra Leonean caregivers scoring above this threshold on the DERS have reported significantly higher levels of severe physical punishment with their children as well as intimate partner violence. Both parents must agree to attend FSI-ECD sessions. If enrolled families have more than one child aged 6-36 months, we will include all eligible children as study participants.
* Community Health Worker Participants: CHWs who are 18 years or older and who are assigned to the Peripheral Health Unit that provides health services in one of our target communities.
* Community Health Worker Supervisor Participants: Supervisors are 18 years or older and oversee CHWs providing maternal and child health services

Exclusion Criteria:

* Focus Group-User Interface/User Experience (UI/UX) Participants: Individuals younger than age 18 and individuals who do not meet inclusion criteria.
* Family Participants: Families who do not meet all inclusion criteria and/or who are experiencing active family crises (e.g., current suicidality or psychosis, cognitive impairment, ongoing divorce process).
* Community Health Worker Participants: Individuals under age 18 cannot be recruited to work as a CHW.
* Community Health Worker Supervisor Participants: Individuals under age 18.
B: Inclusion Criteria:

1. score YES to heart-mind problems on heart-mind screener
2. score \>16 on World Health Organization Disability Assessment Scale

Exclusion Criteria:

1. Presence of a severe mental disorder (e.g., psychosis)
2. Alcohol use disorder (score \>16 on the alcohol use disorders identification test (AUDIT)
C: Inclusion criteria

* Child ages 6 to 12 months at the time of intervention launch residing in the catchment areas of the five study health facilities
* Child's mother or main caregiver must be 15 years or older
* Child's primary caregiver must be a female (because the participants in the caregiver groups may feel uncomfortable discussing certain issues if a man is present)

Exclusion criteria

* Caregivers who are unwilling to provide informed consent
* Families that plan to move from their health center catchment zone during the twelve month period of the study
D: Inclusion Criteria:

* Mothers with a child aged 6-16 months
* Eligible to receive UCT.

  * UCT+HE+PS arm: Receiving unconditional cash from government
  * UCT+HE arm: Receiving unconditional cash from government
  * Comparison arm: eligible to receive UCT but not under UCT programme.
* Not expected to leave the study site for more than 2 months
* Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf.

Exclusion Criteria:

* Legal guardian unwilling or unable to provide written informed consent.
* Known congenital anomaly
* Developmental disorder or severe developmental delay
* Not possible to test the child due to physical or behavioral problems
* Children of multiple birth e.g. twin, triplets

Answer: C