Using Group Interpersonal Psychotherapy to Improve the Well-Being of Adolescent Girls
Last registered on November 17, 2019

Pre-Trial

Trial Information
General Information
Title
Using Group Interpersonal Psychotherapy to Improve the Well-Being of Adolescent Girls
RCT ID
AEARCTR-0004208
Initial registration date
May 20, 2019
Last updated
November 17, 2019 1:05 PM EST
Location(s)

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Primary Investigator
Affiliation
George Washington University
Other Primary Investigator(s)
PI Affiliation
The World Bank
Additional Trial Information
Status
On going
Start date
2019-05-23
End date
2021-08-31
Secondary IDs
NCT03966833
Abstract
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.
External Link(s)
Registration Citation
Citation
Baird, Sarah and Berk Ozler. 2019. "Using Group Interpersonal Psychotherapy to Improve the Well-Being of Adolescent Girls." AEA RCT Registry. November 17. https://doi.org/10.1257/rct.4208-1.1.
Former Citation
Baird, Sarah, Sarah Baird and Berk Ozler. 2019. "Using Group Interpersonal Psychotherapy to Improve the Well-Being of Adolescent Girls." AEA RCT Registry. November 17. https://www.socialscienceregistry.org/trials/4208/history/57198.
Experimental Details
Interventions
Intervention(s)
There are two main interventions:

1. 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.

2. 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 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.
Intervention Start Date
2019-09-01
Intervention End Date
2019-12-31
Primary Outcomes
Primary Outcomes (end points)
psychological wellbeing measured by (i) binary indicators on the GHQ-12 (>=3), (ii) a binary indicator of minimal depression (PHQ-8 <=10) (iii) score on Rosenberg self esteem (0-30) and score on Child & Youth Resilience Measure-Revised (0-34)
Primary Outcomes (explanation)
Secondary Outcomes
Secondary Outcomes (end points)
(i) indicator for being enrolled in school; (ii) the score on a set of competencies (skills) using a module developed by the study team; (iii) risky sex (condom use during last sexual encounter); and (iv) the incidences of marriage and childbearing since baseline.
Secondary Outcomes (explanation)
Experimental Design
Experimental Design
Control Group/Standard ELA Program: 500 female adolescents (aged 13-19) in 50 clusters. The target population will be listed from the ELA BRAC clubs (ELA members) and its immediate vicinity (non-ELA members), screened using the PHQ-8, and invited to participate in the study if their PHQ- scores are above the screening threshold. The ELA clubs will operate as usual in these areas with no other intervention present.

T1. ELA + IPT-G: 500 female adolescents (aged 13-19) in 50 clusters. The target population will be listed from the ELA BRAC clubs (ELA members) and its immediate vicinity (non-ELA members), screened using the PHQ-8, and invited to participate in the study if their PHQ-8 scores are above the screening threshold. The ELA clubs will operate as usual in these areas. The study participants will also receive an
invitation to participate in a 14-week IPT-G.

T2. ELA + IPT-G + Income Support: 500 female adolescents (aged 13-19) in 50 clusters. The target population will be listed from the ELA BRAC clubs (ELA members) and its immediate vicinity (non-ELA members), screened using the PHQ-8, and invited to participate in the study if their PHQ-8 scores are above the screening threshold. The ELA clubs will operate as usual in these areas. The study participants will receive an invitation to participate in a 14-week IPT-G. They will also receive a one time unconditional and unframed cash transfer. 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. The amount of the cash transfer will be pinned to the old age pension which is 25,000UGX per month which is about $7. for 8 months, 8*25,000=200,000UGX ($54).
Experimental Design Details
Not available
Randomization Method
Cluster randomization in the office using Stata 14.
Randomization Unit
The randomization unit is the ELA club.
Was the treatment clustered?
Yes
Experiment Characteristics
Sample size: planned number of clusters
150 ELA Clubs (and surrounding area)
Sample size: planned number of observations
1500
Sample size (or number of clusters) by treatment arms
50 clubs control, 50 clubs IPT-G, 50 clubs IPT-G + cash
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
The primary indicator for psychological wellbeing used in our power calculations is a binary indicator for minimal depression, which indicates a PHQ‐9 score less than 10. At baseline, this measure will be equal to zero. For the power calculations (which were conducted using the clustersampsi command in Stata 14), we assumed that the control group will have a mean of 0.33 at follow‐up. With 50 clusters per arm and 10 individuals per cluster, and assuming an intra‐cluster correlation of 0.1, the minimum detectable increase in minimal depression is 12 percentage points (pp), indicating that we’d be able to detect statically significant differences at the 95% level of confidence with 80% power if the mean in either treatment group is greater than 0.45. This is well within the expected range of impacts based on earlier studies by StrongMinds, and other studies of IPT‐G. The detectable difference between IPT‐G and IPT‐G plus income support is also 12 pp (in either direction), assuming the same parameters and a mean of 0.45 in the IPT‐G group at follow‐up.
IRB
INSTITUTIONAL REVIEW BOARDS (IRBs)
IRB Name
George Washington University’s Institutional Review Board
IRB Approval Date
2019-03-05
IRB Approval Number
180580
IRB Name
Makarere University, Higher Degrees Research and Ethics Commitee
IRB Approval Date
2017-12-13
IRB Approval Number
552
IRB Name
Uganda National Council for Science and Technology
IRB Approval Date
2019-02-12
IRB Approval Number
HS318ES
Analysis Plan

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