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

Primary Purpose

Mental Depression

Status
Completed
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
IPT-G
Unconditional Cash Transfer
Sponsored by
George Washington University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mental Depression

Eligibility Criteria

13 Years - 19 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • male
  • Score below 10 on PHQ-8

Sites / Locations

  • BRAC Uganda

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

group-based interpersonal therapy (IPT-G)

IPT-G + Unconditional Cash Transfer:

control

Arm Description

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.

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.

ELA clubs function as normal

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Indicator for Self-Reported School Enrollment a
Indicator for enrolled in school (=1 if Adolescent Self-Reports Enrolled in school at time of survey)
Indicator for Self-Reported School Enrollment b
Indicator for enrolled in school (=1 if Adolescent Self-Reports Enrolled in school at time of survey)
incidence of pregnancy a
incidence of pregnancy from baseline
incidence of pregnancy b
incidence of pregnancy from baseline
Child Marriage a
incidence of marriage from baseline
Child Marriage b
incidence of marriage from baseline
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
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
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)
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)

Full Information

First Posted
May 21, 2019
Last Updated
November 4, 2022
Sponsor
George Washington University
Collaborators
Berk Ozler, The World Bank
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1. Study Identification

Unique Protocol Identification Number
NCT03966833
Brief Title
Using Group Interpersonal Psychotherapy to Improve the Well-Being of Adolescent Girls
Official Title
Using Group Interpersonal Psychotherapy to Improve the Well-Being of Adolescent Girls
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
May 26, 2019 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
September 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
George Washington University
Collaborators
Berk Ozler, The World Bank

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Enumerators will be masked to the treatment assignment of the participants.
Allocation
Randomized
Enrollment
1914 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group-based interpersonal therapy (IPT-G)
Arm Type
Experimental
Arm Description
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.
Arm Title
IPT-G + Unconditional Cash Transfer:
Arm Type
Experimental
Arm Description
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.
Arm Title
control
Arm Type
No Intervention
Arm Description
ELA clubs function as normal
Intervention Type
Behavioral
Intervention Name(s)
IPT-G
Intervention Description
14 weeks of group-based interpersonal therapy (IPT-G)
Intervention Type
Behavioral
Intervention Name(s)
Unconditional Cash Transfer
Intervention Description
Lump sum cash transfer
Primary Outcome Measure Information:
Title
Minimal Depression 1a
Description
Score <=10 Primary Health Questionnaire 8 (0-24, higher is worse)
Time Frame
6 months
Title
Minimal Depression 1b
Description
Score <=10 Primary Health Questionnaire 8 (0-24, higher is worse)
Time Frame
12 months
Title
Minimal Depression 1c
Description
Score <=10 Primary Health Questionnaire 8 (0-24, higher is worse)
Time Frame
24 months
Title
Psychological Distress 2a
Description
Score >=3 on the General Health Questionnaire 12 (0-12, higher is worse)
Time Frame
6 months
Title
Psychological Distress 2b
Description
Score >=3 on the General Health Questionnaire 12 (0-12, higher is worse)
Time Frame
12 months
Title
Psychological Distress 2c
Description
Score >=3 on the General Health Questionnaire 12 (0-12, higher is worse)
Time Frame
24 months
Title
Self Esteem a
Description
score on Rosenberg self esteem (0-30, higher is better)
Time Frame
6 months
Title
Self Esteem b
Description
score on Rosenberg self esteem (0-30, higher is better)
Time Frame
12 months
Title
Self Esteem c
Description
score on Rosenberg self esteem (0-30, higher is better)
Time Frame
24 months
Title
Resilience a
Description
score on Child & Youth Resilience Measure-Revised (0-34, higher is better)
Time Frame
6 months
Title
Resilience b
Description
score on Child & Youth Resilience Measure-Revised (0-34, higher is better)
Time Frame
12 months
Title
Resilience c
Description
score on Child & Youth Resilience Measure-Revised (0-34, higher is better)
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Indicator for Self-Reported School Enrollment a
Description
Indicator for enrolled in school (=1 if Adolescent Self-Reports Enrolled in school at time of survey)
Time Frame
12 months
Title
Indicator for Self-Reported School Enrollment b
Description
Indicator for enrolled in school (=1 if Adolescent Self-Reports Enrolled in school at time of survey)
Time Frame
24 months
Title
incidence of pregnancy a
Description
incidence of pregnancy from baseline
Time Frame
12 months
Title
incidence of pregnancy b
Description
incidence of pregnancy from baseline
Time Frame
24 months
Title
Child Marriage a
Description
incidence of marriage from baseline
Time Frame
12 months
Title
Child Marriage b
Description
incidence of marriage from baseline
Time Frame
24 months
Title
Competencies a
Description
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
Time Frame
12 months
Title
Competencies b
Description
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
Time Frame
24 months
Title
Indicator for self -reported condom use at last sex a
Description
condom use during last sexual encounter (=1 if Adolescent self reports using a condom at last sex)
Time Frame
12 months
Title
indicator for self-reported condom use at last sex b
Description
condom use during last sexual encounter (=1 if Adolescent self reports using a condom at last sex)
Time Frame
24 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 13-19 year old female who scores 10 or above on PHQ-8 Exclusion Criteria: male Score below 10 on PHQ-8
Facility Information:
Facility Name
BRAC Uganda
City
Kampala
Country
Uganda

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

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

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