Clinical trial NCT03573713: Decreasing Stunting by Reducing Maternal Depression in Uganda: A Cluster Randomized Controlled Trial (CRCT) for Improved Nutrition Outcomes
Official title: Decreasing Stunting by Reducing Maternal Depression in Uganda - A Cluster Randomized Controlled Trial (CRCT) for Improved Nutrition Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression, Postpartum
Malnutrition, Child
Keywords: Hygiene practices
Sanitation
Nutrition
Interpersonal Psychotherapy
Maternal depression
clustered randomized controlled trial
Lead sponsor: Food for the Hungry
Sponsor class: OTHER
Collaborators: name: Teachers College, Columbia University
name: Johns Hopkins University
First posted: 2018-06-29
Enrollment: 1248
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: PREVENTION

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.

Detailed description: Over the past two decades there has been a growing global momentum and commitment to address malnutrition. The most recent indication of this is reflected in goal #2 of the Sustainable Development Goals, "end hunger, achieve food security and improved nutrition and promote sustainable agriculture." However, great challenges remain. Today, over 165 million children under five are chronically malnourished or stunted, and once a child is stunted, it is nearly impossible to regain their cognitive and physical potential. In addition, it is estimated that malnutrition contributes to more than one-third of all child deaths under the age of five.

Through research and fieldwork, key evidence-based interventions and target populations have been identified. It has been found that the most critical time to prevent chronic malnutrition is from conception up through the child's second birthday, known as the "first 1,000 days." Improving household behaviors related to maternal and child health and nutrition such as improved water, sanitation, and hygiene practices, proper infant and young child feeding practices, optimal maternal nutrition and antenatal care, and others can reduce child malnutrition and prevent up to 57% of deaths of children under five years of age.

However, despite the gains in reducing stunting in children, there has been no program implemented at scale that has come close to normalizing child growth. There is a need for new tools and interventions that focus on other causes of malnutrition aside from poor water, sanitation, and hygiene, infant and young child feeding, home management/care seeking for sick children, maternal nutrition/antenatal care, and use of preventive services (e.g., immunizations). One promising new intervention is the treatment of maternal depression, an underlying cause of malnutrition. The potential global impact of adding community-based treatment of maternal depression to the investigator's toolbox of interventions to reduce child stunting could be significant: A recent meta-analysis found that stunting could be reduced globally by about 27% by eliminating maternal depression (Surkan, J, Kennedy C, Hurley, B, and Black, M., 2011). As such, the investigators believe that treatment of maternal depression could result in improved nutrition behavior change in mothers, leading to significant reductions in child stunting and helping to end hunger.

An effective, low-cost, short-duration community-based method for decreasing depression has been established that was first rigorously tested in Uganda: Interpersonal Psychotherapy for Groups. 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. A cluster randomized controlled trial of this approach in depressed adults in southern Ugandan rural communities yielded a 93% decline in diagnosable depression (vs. a 45% decline in controls), as well as significantly higher functionality in household tasks, including those associated with child nutrition and health (Bass et al, 2006). However, this study did not measure changes in maternal adoption of behaviors that affect child nutritional status and the possible effect of treatment of maternal depression on improved child growth. Demonstrating that Interpersonal Psychotherapy for Groups works for increasing maternal adoption of behaviors that affect child nutritional status could have a profound effect on how malnutrition is prevented worldwide, and save children and their mothers from a lot of unnecessary suffering.

Therefore, Food for the Hungry in partnership with the team at the Global Mental Health Lab at Teachers College, Columbia University is proposing a 33 month project which will test how to integrate Interpersonal Psychotherapy for Groups within Care Group projects and whether the treatment of maternal depression with Interpersonal Psychotherapy for Groups improves the adoption of maternal behaviors that can reduce stunting in Kitgum District in northern Uganda. Using a cluster randomized controlled trial design, Food for the Hungry will test whether adding Interpersonal Psychotherapy for Groups for half of the women identified with depression improves the adoption of household health and nutrition behaviors known to improve child linear growth.

Pregnant women and mothers with a child born after 3 April 2016 (who will be under 18 months of age by the time health promotion begins on 4 October 2017) will be assessed for depression, and half of those who meet a cutoff for depression will be randomly assigned to IPT-G. Following the three-month implementation of Interpersonal Psychotherapy for Groups, all pregnant women and women with children under two years of age in the project area will participate in Care Groups, an evidence-based community nutrition promotion model to improve maternal and child health and nutrition behaviors. A recent set of papers summarized the history of Care Groups and the outcomes achieved with the model on children under two years of age in many countries around the world (Perry et al, 2015), and how projects using Care Groups are achieving on average more than double the behavior change of other models on maternal behaviors that affect the growth of children 0-23m (George et al, 2015). 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. Care group experts report improvement of depression as a result of these focus groups, due to the connection, social support and problem-solving among the group members. At the conclusion of this project, a Lessons Learned conference will be held in Uganda and an online dissemination event will be held in order to facilitate the sharing of project results. Results will also be disseminated through peer-reviewed papers and communities of practice.

Eligibility criteria: 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).

Primary outcomes:
measure: Change in scores of KPC Survey of maternal and child health and nutrition behaviors
timeFrame: 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:
measure: Score of survey on home management, referral and care seeking for children
timeFrame: Around week 26 (end of first CG module)
measure: Score of survey on infant and young child feeding practices
timeFrame: Around week 38 (end of second CG module)
measure: Score of survey on water usage, sanitation and hygiene practices
timeFrame: Around week 47(end of third CG module)
measure: Score of survey on knowledge and utility of preventive services available at local health facilities
timeFrame: Around week 56 (end of fourth CG module)
measure: Score of survey on family planning practices
timeFrame: Around week 65 (end of fifth CG module)
Other outcomes:
measure: PHQ-9
timeFrame: 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).
Locations:
city: Kitgum
country: Uganda
facility: FH Uganda - Kitgum
Study officials:
affiliation: Food for the Hungry
name: Godfrey Opiyo, B.S.
role: PRINCIPAL_INVESTIGATOR
affiliation: Food for the Hungry
name: Trisha Okenge
role: STUDY_DIRECTOR
References:
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.
citation: 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.
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.
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.
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.