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

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.

Study Overview

• Status: Completed
• Conditions: Mental Depression
• Intervention / Treatment: Behavioral: IPT-G; Behavioral: Unconditional Cash Transfer

• Study Type: Interventional
• Enrollment (Actual): 1914
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Uganda
  • Kampala, Uganda
    • BRAC Uganda

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 19 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 13-19 year old female who scores 10 or above on PHQ-8

Exclusion Criteria:

• male
• Score below 10 on PHQ-8

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: group-based interpersonal therapy (IPT-G); 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; 14 weeks of group-based interpersonal therapy (IPT-G)
EXPERIMENTAL: IPT-G + Unconditional Cash Transfer: 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; 14 weeks of group-based interpersonal therapy (IPT-G); Behavioral: Unconditional Cash Transfer; Lump sum cash transfer
NO_INTERVENTION: control; ELA clubs function as normal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Indicator for Self-Reported School Enrollment a	Indicator for enrolled in school (=1 if Adolescent Self-Reports Enrolled in school at time of survey)	12 months
Indicator for Self-Reported School Enrollment b	Indicator for enrolled in school (=1 if Adolescent Self-Reports Enrolled in school at time of survey)	24 months
incidence of pregnancy a	incidence of pregnancy from baseline	12 months
incidence of pregnancy b	incidence of pregnancy from baseline	24 months
Child Marriage a	incidence of marriage from baseline	12 months
Child Marriage b	incidence of marriage from baseline	24 months
Competencies a	Score on competency test. This is a score that takes on a value of 0-3 across a set of three questions on ability to answer skills based math questions. Higher is better	12 months
Competencies b	Score on competency test. This is a score that takes on a value of 0-3 across a set of three questions on ability to answer skills based math questions. Higher is better	24 months
Indicator for self -reported condom use at last sex a	condom use during last sexual encounter (=1 if Adolescent self reports using a condom at last sex)	12 months
indicator for self-reported condom use at last sex b	condom use during last sexual encounter (=1 if Adolescent self reports using a condom at last sex)	24 months

Collaborators and Investigators

• Sponsor: George Washington University
• Collaborators: Berk Ozler, The World Bank

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 26, 2019
• Primary Completion (ACTUAL): September 30, 2022
• Study Completion (ACTUAL): September 30, 2022

Study Registration Dates

• First Submitted: May 21, 2019
• First Submitted That Met QC Criteria: May 24, 2019
• First Posted (ACTUAL): May 29, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 8, 2022
• Last Update Submitted That Met QC Criteria: November 4, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: SMU/BRAC 2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be made available at the conclusion of the study.
• IPD Sharing Time Frame: Data will be made available at the conclusion of the study.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No