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

Mental Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03966833
• Other study ID #: SMU/BRAC 2019
• Status: Completed
• Phase: N/A
• Start date: May 26, 2019
• Est. completion date: September 30, 2022

Study information

• Verified date: November 2022
• Source: George Washington University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1914
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 13 Years to 19 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• male

• Score below 10 on PHQ-8

Related Conditions & MeSH terms

• Depression
• Mental Depression

Intervention

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

Locations

Country	Name	City	State
Uganda	BRAC Uganda	Kampala

Sponsors (2)

Lead Sponsor	Collaborator
George Washington University	Berk Ozler, The World Bank

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Minimal Depression 1a	Score <=10 Primary Health Questionnaire 8 (0-24, higher is worse)	6 months
Primary	Minimal Depression 1b	Score <=10 Primary Health Questionnaire 8 (0-24, higher is worse)	12 months
Primary	Minimal Depression 1c	Score <=10 Primary Health Questionnaire 8 (0-24, higher is worse)	24 months
Primary	Psychological Distress 2a	Score >=3 on the General Health Questionnaire 12 (0-12, higher is worse)	6 months
Primary	Psychological Distress 2b	Score >=3 on the General Health Questionnaire 12 (0-12, higher is worse)	12 months
Primary	Psychological Distress 2c	Score >=3 on the General Health Questionnaire 12 (0-12, higher is worse)	24 months
Primary	Self Esteem a	score on Rosenberg self esteem (0-30, higher is better)	6 months
Primary	Self Esteem b	score on Rosenberg self esteem (0-30, higher is better)	12 months
Primary	Self Esteem c	score on Rosenberg self esteem (0-30, higher is better)	24 months
Primary	Resilience a	score on Child & Youth Resilience Measure-Revised (0-34, higher is better)	6 months
Primary	Resilience b	score on Child & Youth Resilience Measure-Revised (0-34, higher is better)	12 months
Primary	Resilience c	score on Child & Youth Resilience Measure-Revised (0-34, higher is better)	24 months
Secondary	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
Secondary	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
Secondary	incidence of pregnancy a	incidence of pregnancy from baseline	12 months
Secondary	incidence of pregnancy b	incidence of pregnancy from baseline	24 months
Secondary	Child Marriage a	incidence of marriage from baseline	12 months
Secondary	Child Marriage b	incidence of marriage from baseline	24 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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