## Protocol Section
### Identification Module
**NCT ID:** NCT02619279

**Brief Title:** A Livelihood Intervention for Impoverished Women and Children in Rural Uganda

**Official Title:** A Livelihood Intervention for Impoverished Women and Children in Rural Uganda: Randomized Controlled Trial

#### Organization Study ID Info
**ID:** MH096620-S4
#### Organization
**Class:** OTHER
**Full Name:** Massachusetts General Hospital
### Status Module
#### Completion Date
**Date:** 2016-12

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2015-12-02

**Type:** ESTIMATED

**Last Update Submit Date:** 2015-12-01

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2016-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2015-11

**Status Verified Date:** 2015-12

#### Study First Post Date
**Date:** 2015-12-02
**Type:** ESTIMATED
**Study First Submit Date:** 2015-08-15
**Study First Submit QC Date:** 2015-12-01
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Mbarara University of Science and Technology

#### Lead Sponsor

**Class:** OTHER

**Name:** Massachusetts General Hospital

#### Responsible Party

**Investigator Affiliation:** Massachusetts General Hospital

**Investigator Full Name:** Alexander Tsai

**Investigator Title:** Assistant Professor of Psychiatry

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The objective of the study is to determine whether a livelihood intervention can improve health and schooling outcomes of the children of woman participating in a livelihood intervention in rural Uganda.

### Conditions Module

**Conditions:**

- Indigency

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

#### Enrollment Info

**Count:** 150

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants' mothers will receive a livelihood intervention package consisting of a orientation and training and a loan package of chickens and associated implements to create poultry microenterprises

**Intervention Names:**

- Other: Livelihood intervention

**Label:** Immediate treatment

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Participants' mothers will receive no intervention but will be placed on a waitlist to receive the intervention after a 12-month delay.

**Label:** Delayed treatment

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Immediate treatment

**Description:** Participants' mothers will receive a livelihood intervention package consisting of a orientation and training and a loan package of chickens and associated implements to create poultry microenterprises.

**Name:** Livelihood intervention

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Height-for-age calculated based on child height and child age, measured for children under 5 years of age

**Measure:** Stunting based on Anthropometric Measurements

**Time Frame:** 12 months

**Description:** Weight-for-height calculated based on child height and child weight, measured for children under 5 years of age

**Measure:** Weight-for-Height based on Anthropometric Measurements

**Time Frame:** 12 months

**Description:** Raven's Colored Progressive Matrices test score (range, 0-18), measured for children aged 5-8 years

**Measure:** Raven's Colored Progressive Matrices test

**Time Frame:** 12 months

**Description:** Mullen Early Learning Scales: 144 items total, divided across 4 subtests in visual receptive organization, visual expressive organization, language expressive organization, and language receptive organization

**Measure:** Mullen Early Learning Scales

**Time Frame:** 12 months

**Description:** Home Observation of the Measurement of Environment, modified for the Ugandan context (58 items distributed across the following domains: Responsivity, Encouragement of maturity, Emotional climate, Learning materials and opportunities, Enrichment, Family companionship, Family integration and Physical environment)

**Measure:** Home Observation of the Measurement of Environment Scale

**Time Frame:** 12 months

#### Secondary Outcomes

**Description:** Average time spent on school and schoolwork in the past 7 days (number of hours)

**Measure:** Child Educational Investment Scale

**Time Frame:** 12 months

**Description:** Average time spent on household chores and playing in the past 7 days (number of hours)

**Measure:** Child Non-Educational Investment Scale

**Time Frame:** 12 months

**Description:** Average time spent on reading to children or helping with homework in past 7 days (number of hours)

**Measure:** Mother's Educational Investment Scale

**Time Frame:** 12 months

**Description:** Mother's aspiration for child's educational attainment, ranging from 1 (finish P7 primary school) to 5 (finish graduate school)

**Measure:** Mother's Aspirations for Child Education Scale

**Time Frame:** 12 months

**Description:** Mother's aspirations for child's adult employment by age 25 (with the option to select one of 33 different blue-collar and white-collar occupational categories)

**Measure:** Mother's Aspirations for Child Career Scale

**Time Frame:** 12 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* All children under 18 years

Exclusion Criteria:

* Adults older than 18 years

**Healthy Volunteers:** True

**Maximum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** actsai@partners.org

**Name:** Alexander C Tsai, MD, PhD

**Phone:** 617-724-1120

**Role:** CONTACT

**Contact 2:**

**Email:** baitwakaku@gmail.com

**Name:** Bernard Kakuhikire, MBA

**Phone:** 256-075-250-4030

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Mbarara

**Contacts:**

***Contact 1:***

- **Email:** actsai@partners.org

- **Name:** Alexander C Tsai, MD, PhD

- **Phone:** 617-724-1120

- **Role:** CONTACT

***Contact 2:***

- **Email:** baitwakaku@gmail.com

- **Name:** Bernard Kakuhikire, MBA

- **Phone:** 256-075-250-4030

- **Role:** CONTACT

***Contact 3:***

- **Name:** Alexander C Tsai, MD, PhD

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 4:***

- **Name:** Bernard Kakuhikire, MBA

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Uganda

**Facility:** Mbarara University of Science and Technology

**Status:** RECRUITING

#### Overall Officials

**Official 1:**

**Affiliation:** Massachusetts General Hospital

**Name:** Alexander C Tsai, MD, PhD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** Mbarara University of Science and Technology

**Name:** Bernard Kakuhikire, MBA

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-24
