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

• ClinicalTrials.gov Identifier: NCT03966833
• Recruitment Status: Completed
• First Posted: May 29, 2019
• Last Update Posted: November 8, 2022
• Sponsor: George Washington University
• Collaborator: Berk Ozler, The World Bank
• Information provided by (Responsible Party): Sarah Baird, George Washington University

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.

Condition or disease	Intervention/treatment	Phase
Mental Depression	Behavioral: IPT-G; Behavioral: Unconditional Cash Transfer	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1914 participants
• 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
• Official Title: Using Group Interpersonal Psychotherapy to Improve the Well-Being of Adolescent Girls
• Actual Study Start Date: May 26, 2019
• Actual Primary Completion Date: September 30, 2022
• Actual Study Completion Date: September 30, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. 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)
2. 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)
3. incidence of pregnancy a [ Time Frame: 12 months ]
   incidence of pregnancy from baseline
4. incidence of pregnancy b [ Time Frame: 24 months ]
   incidence of pregnancy from baseline
5. Child Marriage a [ Time Frame: 12 months ]
   incidence of marriage from baseline
6. Child Marriage b [ Time Frame: 24 months ]
   incidence of marriage from baseline
7. 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
8. 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
9. 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)
10. 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)

Eligibility Criteria

• Ages Eligible for Study: 13 Years to 19 Years (Child, Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

Uganda

BRAC Uganda

Kampala, Uganda

Sponsors and Collaborators

George Washington University

Berk Ozler, The World Bank

More Information

• Responsible Party: Sarah Baird, Associate Professor, George Washington University
• ClinicalTrials.gov Identifier: NCT03966833
• Other Study ID Numbers: SMU/BRAC 2019
• First Posted: May 29, 2019
• Last Update Posted: November 8, 2022
• Last Verified: November 2022

Individual Participant Data (IPD) Sharing Statement:

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

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

Additional relevant MeSH terms:

Depression; Behavioral Symptoms