Depression, Postpartum Clinical Trial
Official title:
Decreasing Stunting by Reducing Maternal Depression in Uganda - A Cluster Randomized Controlled Trial (CRCT) for Improved Nutrition Outcomes
Verified date | February 2020 |
Source | Food for the Hungry |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 1248 |
Est. completion date | April 15, 2019 |
Est. primary completion date | April 15, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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). |
Country | Name | City | State |
---|---|---|---|
Uganda | FH Uganda - Kitgum | Kitgum |
Lead Sponsor | Collaborator |
---|---|
Food for the Hungry | Johns Hopkins University, Teachers College, Columbia University |
Uganda,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. Review. Erratum in: Bull World Health Organ. 2011 Sep 1;89(9):631. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | PHQ-9 | The 9-Item Patient Health Questionnaire (PHQ-9) assesses an individual for their depression-related feelings and thoughts. The PHQ-9 questions are based on diagnostic criteria of depression from DSM-IV and ask about the patient's experience in the last 2 weeks. Questions are about the level of interest in doing things, feeling down or depressed, difficulty with sleeping, energy levels, eating habits, self-perception, ability to concentrate, speed of functioning and thoughts of suicide. Responses range from "0" (Not at all) to "3" (nearly every day). Clinicians may ask a 10th question that asks how difficult the problems that the prior questions ask about make it to function in daily life. The 10th question is not factored into the final score and clinicians may use it to gauge the patient's opinion of the level of impairment caused by their mental health. | 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). | |
Primary | 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 | Score of survey on home management, referral and care seeking for children | Whether or not mothers of children 0-23m of age who had rapid/difficult breathing or fever in the past two weeks sought care from an appropriate health care provider within 24 hrs of symptoms. Whether or not mothers of children with an illness in the past two weeks gave their child the same/more food or increased breastfeeding in children 0-5m. Whether or not mothers had their child sleep under a long-lasting insecticide-treated net during the past night. Number of signs of childhood illness that require immediately seeking assessment and treatment by a health facility or provider outside of the home known by the mother. (Note: Since these signs of severe illness will affect few children, we are measuring a knowledge indicator here as a proxy for behavior change.) |
Around week 26 (end of first CG module) | |
Secondary | Score of survey on infant and young child feeding practices | Whether or not mothers of children 0-5m are exclusively breastfed and mothers of children 6-23 months of age are giving the child a minimum acceptable diet (apart from breast milk). Whether or not mothers of children 6-23 months of age are giving their child an iron-rich food or iron-fortified food that is specially designed for infants and young children, or that is fortified in the home. |
Around week 38 (end of second CG module) | |
Secondary | Score of survey on water usage, sanitation and hygiene practices | Whether or not mothers with children age 0-23 months have soap and water at a hand washing location readily available. Whether or not mothers report proper disposal of the child's feces the last time the child defecated. Whether or not mothers treat household drinking water effectively. Whether or not the mother is depressed. |
Around week 47(end of third CG module) | |
Secondary | Score of survey on knowledge and utility of preventive services available at local health facilities | Whether or not mothers had their child's growth monitored in the past 3 months. Whether or not children 6-24m of mothers received one dose of vitamin A in the past 6m. Whether or not children 9-24m of mothers have received rotavirus vaccine. |
Around week 56 (end of fourth CG module) | |
Secondary | Score of survey on family planning practices | ? Whether or not mothers are using an effective method of family planning. | Around week 65 (end of fifth CG module) |
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