Using Group Interpersonal Psychotherapy to Improve the Well-Being of Adolescent Girls

NCT03966833 | Completed

• 1 other identifier: SMU/BRAC 2019
• Study Type: interventional
• Target: 1,914
• Locations: 1 country
• Sites: 1

Brief Summary

Adolescent girls in developing countries face high rates of adversity and are at an elevated risk of depression and other forms of psychological distress. Untreated depression can have negative consequences on life outcomes such as early pregnancies, social exclusion and school dropout. These can result in a cycle of poverty for young women and their families. Despite this being a very pressing problem there is little evidence on what types of interventions can help break the vicious cycle of poor mental health and poverty. This research program aims to evaluate, through the use of a cluster-Randomized Control Trial (cluster- RCT), the effect of group-based interpersonal psychotherapy (IPT-G) and unconditional cash transfers on adolescent girls' mental health and social functioning. Working with Strong Minds Uganda in collaboration with BRAC Uganda's Empowerment and Livelihood for Adolescents (ELA) clubs, the evidence generated from this research will create a better understanding of whether adolescent mental health improves through this cost-effective approach, and whether improved mental health impacts other outcomes of interest.

Conditions

Mental Depression

Outcome Measures

Primary Outcomes (12)

• Minimal Depression 1a

  Score \<=10 Primary Health Questionnaire 8 (0-24, higher is worse)

  6 months

• Minimal Depression 1b

  Score \<=10 Primary Health Questionnaire 8 (0-24, higher is worse)

  12 months

• Minimal Depression 1c

  Score \<=10 Primary Health Questionnaire 8 (0-24, higher is worse)

  24 months

• Psychological Distress 2a

  Score \>=3 on the General Health Questionnaire 12 (0-12, higher is worse)

  6 months

• Psychological Distress 2b

  Score \>=3 on the General Health Questionnaire 12 (0-12, higher is worse)

  12 months

• Psychological Distress 2c

  Score \>=3 on the General Health Questionnaire 12 (0-12, higher is worse)

  24 months

• Self Esteem a

  score on Rosenberg self esteem (0-30, higher is better)

  6 months

• Self Esteem b

  score on Rosenberg self esteem (0-30, higher is better)

  12 months

• Self Esteem c

  score on Rosenberg self esteem (0-30, higher is better)

  24 months

• Resilience a

  score on Child \& Youth Resilience Measure-Revised (0-34, higher is better)

  6 months

• Resilience b

  score on Child \& Youth Resilience Measure-Revised (0-34, higher is better)

  12 months

• Resilience c

  score on Child \& Youth Resilience Measure-Revised (0-34, higher is better)

  24 months

Secondary Outcomes (10)

• Indicator for Self-Reported School Enrollment a

  12 months

• Indicator for Self-Reported School Enrollment b

  24 months

• incidence of pregnancy a

  12 months

• incidence of pregnancy b

  24 months

• Child Marriage a

  12 months

Study Arms (3)

group-based interpersonal therapy (IPT-G)

EXPERIMENTAL

14 weeks of group-based interpersonal therapy (IPT-G): StrongMinds is focused on treating depression in Uganda by training community members (in this case ELA club mentors) to act as mentors in IPT-G techniques. This intervention will be offered to 13-19 year old young women who score a 10 or higher on the PHQ-8. These adolescents who take up the offer will then be enrolled in the 14 weeks of therapy. Group therapy sessions build bonds between young women and encourage them to actively engage in the healing process and to support each other in the exploration of their depression triggers. With new healthier patterns and skills, women can learn to manage their current depression and ensure future depressive episodes can be quickly identified and resolved before the onset of any long-term consequences.

Behavioral: IPT-G

IPT-G + Unconditional Cash Transfer:

EXPERIMENTAL

A one time lump sum of 200,000 UGX (\~$54) be provided to all study participants in a random sub-set of intervention (IPT-G) clusters near or at the conclusion of the 14-week therapy. This treatment variation will allow for determination of whether complimentary income support enhances the effects of IPT-G on psychological wellbeing and other outcomes of interest.

Behavioral: IPT-G; Behavioral: Unconditional Cash Transfer

control

NO INTERVENTION

ELA clubs function as normal

Interventions

IPT-G BEHAVIORAL

14 weeks of group-based interpersonal therapy (IPT-G)

IPT-G + Unconditional Cash Transfer:; group-based interpersonal therapy (IPT-G)

Unconditional Cash Transfer BEHAVIORAL

Lump sum cash transfer

IPT-G + Unconditional Cash Transfer:

Eligibility Criteria

• Age: 13 Years - 19 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• year old female who scores 10 or above on PHQ-8

You may not qualify if:

• male
• Score below 10 on PHQ-8

Sponsors & Collaborators

• George Washington University: lead
• Berk Ozler, The World Bank: collaborator

Study Sites (1)

BRAC Uganda

Kampala, Uganda

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Enumerators will be masked to the treatment assignment of the participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 21, 2019
• First Posted: May 29, 2019
• Study Start: May 26, 2019
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: November 8, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will be made available at the conclusion of the study.

Locations

UG (1)