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

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ClinicalTrials.gov Identifier: NCT03966833

Recruitment Status : Completed

First Posted : May 29, 2019

Last Update Posted : November 8, 2022

View this study on the modernized ClinicalTrials.gov

Sponsor:

Collaborator:

Berk Ozler, The World Bank

Information provided by (Responsible Party):

Sarah Baird, George Washington University

Tracking Information

First Submitted Date ^ICMJE

May 21, 2019

First Posted Date ^ICMJE

May 29, 2019

Last Update Posted Date

November 8, 2022

Actual Study Start Date ^ICMJE

May 26, 2019

Actual Primary Completion Date

September 30, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Minimal Depression 1a [ Time Frame: 6 months ]
Score <=10 Primary Health Questionnaire 8 (0-24, higher is worse)
Minimal Depression 1b [ Time Frame: 12 months ]
Score <=10 Primary Health Questionnaire 8 (0-24, higher is worse)
Minimal Depression 1c [ Time Frame: 24 months ]
Score <=10 Primary Health Questionnaire 8 (0-24, higher is worse)
Psychological Distress 2a [ Time Frame: 6 months ]
Score >=3 on the General Health Questionnaire 12 (0-12, higher is worse)
Psychological Distress 2b [ Time Frame: 12 months ]
Score >=3 on the General Health Questionnaire 12 (0-12, higher is worse)
Psychological Distress 2c [ Time Frame: 24 months ]
Score >=3 on the General Health Questionnaire 12 (0-12, higher is worse)
Self Esteem a [ Time Frame: 6 months ]
score on Rosenberg self esteem (0-30, higher is better)
Self Esteem b [ Time Frame: 12 months ]
score on Rosenberg self esteem (0-30, higher is better)
Self Esteem c [ Time Frame: 24 months ]
score on Rosenberg self esteem (0-30, higher is better)
Resilience a [ Time Frame: 6 months ]
score on Child & Youth Resilience Measure-Revised (0-34, higher is better)
Resilience b [ Time Frame: 12 months ]
score on Child & Youth Resilience Measure-Revised (0-34, higher is better)
Resilience c [ Time Frame: 24 months ]
score on Child & Youth Resilience Measure-Revised (0-34, higher is better)

Original Primary Outcome Measures ^ICMJE

Psychological Distress 1a [ Time Frame: 6 months ]
Score >=10 on the Primary Health Questionnaire 8
Psychological Distress 1b [ Time Frame: 12 months ]
Score >=10 on the Primary Health Questionnaire 8
Psychological Distress 1c [ Time Frame: 24 months ]
Score >=10 on the Primary Health Questionnaire 8
Psychological Distress 2a [ Time Frame: 6 months ]
Score >=3 on the General Health Questionnaire 12
Psychological Distress 2b [ Time Frame: 12 months ]
Score >=3 on the General Health Questionnaire 12
Psychological Distress 2c [ Time Frame: 24 months ]
Score >=3 on the General Health Questionnaire 12
Self Esteem a [ Time Frame: 6 months ]
score on Rosenberg self esteem (0-30)
Self Esteem b [ Time Frame: 12 months ]
score on Rosenberg self esteem (0-30)
Self Esteem c [ Time Frame: 24 months ]
score on Rosenberg self esteem (0-30)
Resilience a [ Time Frame: 6 months ]
score on Child & Youth Resilience Measure-Revised (0-34)
Resilience b [ Time Frame: 12 months ]
score on Child & Youth Resilience Measure-Revised (0-34)
Resilience c [ Time Frame: 24 months ]
score on Child & Youth Resilience Measure-Revised (0-34)

Change History

Current Secondary Outcome Measures ^ICMJE

Indicator for Self-Reported School Enrollment a [ Time Frame: 12 months ]
Indicator for enrolled in school (=1 if Adolescent Self-Reports Enrolled in school at time of survey)
Indicator for Self-Reported School Enrollment b [ Time Frame: 24 months ]
Indicator for enrolled in school (=1 if Adolescent Self-Reports Enrolled in school at time of survey)
incidence of pregnancy a [ Time Frame: 12 months ]
incidence of pregnancy from baseline
incidence of pregnancy b [ Time Frame: 24 months ]
incidence of pregnancy from baseline
Child Marriage a [ Time Frame: 12 months ]
incidence of marriage from baseline
Child Marriage b [ Time Frame: 24 months ]
incidence of marriage from baseline
Competencies a [ Time Frame: 12 months ]
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
Competencies b [ Time Frame: 24 months ]
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
Indicator for self -reported condom use at last sex a [ Time Frame: 12 months ]
condom use during last sexual encounter (=1 if Adolescent self reports using a condom at last sex)
indicator for self-reported condom use at last sex b [ Time Frame: 24 months ]
condom use during last sexual encounter (=1 if Adolescent self reports using a condom at last sex)

Original Secondary Outcome Measures ^ICMJE

Psychological Distress 4a [ Time Frame: 6 months ]
Continuous measure on PHQ-8
Psychological Distress 4b [ Time Frame: 12 months ]
Continuous measure on PHQ-8
Psychological Distress 4c [ Time Frame: 24 months ]
Continuous measure on PHQ-8
Psychological Distress 5a [ Time Frame: 6 months ]
Continuous measure on GHQ-12
Psychological Distress 5b [ Time Frame: 12 months ]
Continuous measure on GHQ-12
Psychological Distress 5c [ Time Frame: 24 months ]
Continuous measure on GHQ-12
School Enrollment a [ Time Frame: 12 months ]
Indicator for enrolled in school
School Enrollment b [ Time Frame: 24 months ]
Indicator for enrolled in school
Exposure to Violence a [ Time Frame: 12 months ]
indicator for exposure to any type of violence in the past 12 months
Exposure to Violence b [ Time Frame: 24 months ]
indicator for exposure to any type of violence in the past 12 months
teen pregnancy a [ Time Frame: 12 months ]
indicator for pregnant at 19 or younger
teen pregnancy b [ Time Frame: 24 months ]
indicator for pregnant at 19 or younger
Child Marriage a [ Time Frame: 12 months ]
indicator for child marriage (married before age 18)
Child Marriage b [ Time Frame: 24 months ]
indicator for child marriage (married before age 18)
Competencies a [ Time Frame: 12 months ]
Score on competency test. This is a score that takes on a value of 0-4 across a set of four questions on ability to answer skills based math questioons.
Competencies b [ Time Frame: 24 months ]
Score on competency test. This is a score that takes on a value of 0-4 across a set of four questions on ability to answer skills based math questioons.

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Not Applicable

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description:

Enumerators will be masked to the treatment assignment of the participants.

Primary Purpose: Treatment

Condition ^ICMJE

Mental Depression

Intervention ^ICMJE

Behavioral: IPT-G
14 weeks of group-based interpersonal therapy (IPT-G)
Behavioral: Unconditional Cash Transfer
Lump sum cash transfer

Study Arms ^ICMJE

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.

Intervention: Behavioral: 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.
Interventions:
- Behavioral: IPT-G
- Behavioral: Unconditional Cash Transfer
No Intervention: control
ELA clubs function as normal

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Actual Enrollment ^ICMJE

1914

Original Estimated Enrollment ^ICMJE

2000

Actual Study Completion Date ^ICMJE

September 30, 2022

Actual Primary Completion Date

September 30, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

male
Score below 10 on PHQ-8

Sex/Gender ^ICMJE

Sexes Eligible for Study:

Female

Ages ^ICMJE

13 Years to 19 Years (Child, Adult)

Accepts Healthy Volunteers ^ICMJE

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Uganda

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT03966833

Other Study ID Numbers ^ICMJE

SMU/BRAC 2019

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

IPD Sharing Statement ^ICMJE

Plan to Share IPD:	Yes
Plan Description:	Data will be made available at the conclusion of the study.
Supporting Materials:	Study Protocol
Supporting Materials:	Statistical Analysis Plan (SAP)
Supporting Materials:	Informed Consent Form (ICF)
Supporting Materials:	Analytic Code
Time Frame:	Data will be made available at the conclusion of the study.