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Completed

NCT Number: NCT03966833

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

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.

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Key information

Conditions

Mental Depression Behavior Behavioral Symptoms Depression

Age range

13 year–19 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

BRAC Uganda

Kampala, Uganda

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • male
  • Score below 10 on PHQ-8

Treatment and study plan

IPT-G

Behavioral

14 weeks of group-based interpersonal therapy (IPT-G)

Unconditional Cash Transfer

Behavioral

Lump sum cash transfer

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

George Washington University

Other

Collaborators

  • Berk Ozler, The World Bank

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
May 29, 2019
Registry last updated
Nov 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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