Decreasing Stunting by Reducing Maternal Depression in Uganda: A Cluster Randomized Controlled Trial (CRCT) for Improved Nutrition Outcomes

NCT03573713 | Completed DMC

• 1 other identifier: FHU-ECF
• Study Type: interventional
• Target: 1,248
• Locations: 1 country
• Sites: 1

Brief Summary

The project seeks to test the integration of Interpersonal Psychotherapy for Groups within Care Group projects and investigate whether the treatment of maternal depression with Interpersonal Psychotherapy for Groups improves the adoption of nutrition-related behaviors that can reduce stunting in the Kitgum District in northern Uganda. A secondary aim is to examine whether the participation in the care groups will also result in remission of depression as a non-specific therapeutic effect although it may not be intended as an antidepressant treatment.

Conditions

Depression, Postpartum; Malnutrition, Child

Keywords

Hygiene practices; Sanitation; Nutrition; Interpersonal Psychotherapy; Maternal depression; clustered randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Change in scores of KPC Survey of maternal and child health and nutrition behaviors

  The "Knowledge, Practices and Coverage" (KPC) survey will measure mothers' endorsement of infant and young child feeding (IYCF) practices; proper water, sanitation, and hygiene (WASH) behaviors; management of childhood illnesses; home management, referral and care seeking for sick children; family planning; and use of preventive services available at health facilities (e.g., growth monitoring, deworming, vitamin A supplementation).

  From date of randomization up to 112 weeks. The KPC survey will be administered at three time points: at baseline immediately after randomization; at midpoint (14 weeks after treatment begins), and at termination (at around week 112).

Secondary Outcomes (5)

• Score of survey on home management, referral and care seeking for children

  Around week 26 (end of first CG module)

• Score of survey on infant and young child feeding practices

  Around week 38 (end of second CG module)

• Score of survey on water usage, sanitation and hygiene practices

  Around week 47(end of third CG module)

• Score of survey on knowledge and utility of preventive services available at local health facilities

  Around week 56 (end of fourth CG module)

• Score of survey on family planning practices

  Around week 65 (end of fifth CG module)

Other Outcomes (1)

• PHQ-9

  From date of randomization up to 112 weeks. The KPC survey will be administered at three time points: at baseline immediately after randomization; at midpoint (14 weeks after treatment begins), and at termination (at around week 112).

Study Arms (2)

IPT-G (Treatment arm)

EXPERIMENTAL

This arm will receive IPT-G for 12 weeks. Following IPT-G, this arm will go on to receive the Care Group intervention parallel to the control arm.

Behavioral: IPT-G

Control arm (Treatment as usual - Care Group)

OTHER

This arm will receive assessment only at the beginning of the study (parallel to the start of IPT-G) and then receive the Care Group intervention after 12 weeks together with the IPT-G arm.

Other: Care Groups

Interventions

Care Groups OTHER

The Care Groups model has strong evidence of improvement of maternal and child health and maternal hygiene/nutrition behaviors.Through Care Groups, women will learn about proper water, sanitation, and hygiene behaviors; Infant and Young Child Feeding practices; management of childhood illnesses; home management, referral and care seeking for sick children; family planning; and use of preventive services available at health facilities (e.g., growth monitoring, deworming, vitamin A supplementation). All children under five years of age will also be screened for acute malnutrition by the Care Group Volunteers, and receive deworming medication and vitamin A supplementation twice a year through the Ministry of Health and Community Health Workers as part of national campaigns.

Also known as: CG

Control arm (Treatment as usual - Care Group)

IPT-G BEHAVIORAL

IPT-G is an effective, low-cost, short-duration community-based method for decreasing depression has been established that was first rigorously tested in Uganda. Several Private Voluntary Organizations in Africa have used this low-cost, short-duration, community-based group psychosocial approach and found it to be a culturally-sensitive, acceptable, and feasible approach to address depression. IPT-G treatment spans 12 weeks of treatment, consisting of 3 phases (early, middle, and termination). Within this treatment, participants are also assessed for symptoms of depression every week.

Also known as: Interpersonal Psychotherapy for Groups

IPT-G (Treatment arm)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Our study will only include depressed pregnant women and depressed mothers (ages 18 and up) with at least one child under 18 months of age (0-17.9 months) who consent and reside in selected communities in subcounties of Kitgum District of Uganda, as we are aiming to study the effects of the treatment of maternal depression on child care practices during the first few years of life. We will not exclude any classes of subject based on class, race, or ethnicity.

You may not qualify if:

• If a woman confirms current risk of suicide or another acute mental health condition (such as psychosis, mania, etc.), she will not be enrolled, but referred to the nearby Peter C. Alderman Kitgum Clinic (Director, Raymond Odonkonyero).

Sponsors & Collaborators

• Food for the Hungry: lead
• Teachers College, Columbia University: collaborator
• Johns Hopkins University: collaborator

Study Sites (1)

FH Uganda - Kitgum

Kitgum, +256, Uganda

Location

Related Publications (5)

• Surkan PJ, Kennedy CE, Hurley KM, Black MM. Maternal depression and early childhood growth in developing countries: systematic review and meta-analysis. Bull World Health Organ. 2011 Aug 1;89(8):608-15. doi: 10.2471/BLT.11.088187. Epub 2011 May 26.

  PMID: 21836759 BACKGROUND

• Bass J, Neugebauer R, Clougherty KF, Verdeli H, Wickramaratne P, Ndogoni L, Speelman L, Weissman M, Bolton P. Group interpersonal psychotherapy for depression in rural Uganda: 6-month outcomes: randomised controlled trial. Br J Psychiatry. 2006 Jun;188:567-73. doi: 10.1192/bjp.188.6.567.

  PMID: 16738348 BACKGROUND

• Perry H, Morrow M, Borger S, Weiss J, DeCoster M, Davis T, Ernst P. Care Groups I: An Innovative Community-Based Strategy for Improving Maternal, Neonatal, and Child Health in Resource-Constrained Settings. Glob Health Sci Pract. 2015 Sep 15;3(3):358-69. doi: 10.9745/GHSP-D-15-00051. Print 2015 Sep.

  PMID: 26374798 BACKGROUND

• Perry H, Morrow M, Davis T, Borger S, Weiss J, DeCoster M, Ricca J, Ernst P. Care Groups II: A Summary of the Child Survival Outcomes Achieved Using Volunteer Community Health Workers in Resource-Constrained Settings. Glob Health Sci Pract. 2015 Sep 15;3(3):370-81. doi: 10.9745/GHSP-D-15-00052. Print 2015 Sep.

  PMID: 26374799 BACKGROUND

• George CM, Vignola E, Ricca J, Davis T, Perin J, Tam Y, Perry H. Evaluation of the effectiveness of care groups in expanding population coverage of Key child survival interventions and reducing under-5 mortality: a comparative analysis using the lives saved tool (LiST). BMC Public Health. 2015 Sep 2;15:835. doi: 10.1186/s12889-015-2187-2.

  PMID: 26329824 BACKGROUND

Related Links

• United Nations Sustainable Development Goals

MeSH Terms

Conditions

Depression, Postpartum; Child Nutrition Disorders

Interventions

Interpersonal Psychotherapy; Population Groups

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Demography; Population Characteristics

Study Officials

• Godfrey Opiyo, B.S.

  Food for the Hungry

  PRINCIPAL INVESTIGATOR

• Trisha Okenge

  Food for the Hungry

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: FH Uganda ECF Program Coordinator

Model Details: IPT-G Promoters will screen all women for depression who are pregnant or will have a child who will be 18m old or younger by 2 May 2018 in each of the 34 Care Group Service Areas chosen for the study. If informed consent is obtained and the women's scores on the PHQ-9 indicate mild to severe depression, they will be put into groups of approx. 8 women for IPT-G. The 34 Care Group Service Areas (CGSAs) will then be randomized into 2 arms (IPT-G and control). Women in the CGSAs in the IPT-G arm who screen positive for depression will receive IPT-G for 12 weeks. Following IPT-G treatment, all women who are pregnant or that have a child born on or after 3 August 2016 in the project area will be provided with psychoeducation through the Care Group structure. For the assessments conducted after the baseline, trained external (non-staff) enumerators will be used to assess for depression and other things, and they will be blind to which group the mothers are in (treatment or control).

Study Record Dates

• First Submitted: March 15, 2018
• First Posted: June 29, 2018
• Study Start: September 11, 2017
• Primary Completion: April 15, 2019
• Study Completion: April 15, 2019
• Last Updated: February 7, 2020

Record last verified: 2020-02

Locations

UG (1)