Decreasing Stunting by Reducing Maternal Depression in Uganda: A Cluster Randomized Controlled Trial (CRCT) for Improved Nutrition Outcomes
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|ClinicalTrials.gov Identifier: NCT03573713|
Recruitment Status : Active, not recruiting
First Posted : June 29, 2018
Last Update Posted : June 29, 2018
|Condition or disease||Intervention/treatment||Phase|
|Depression, Postpartum Malnutrition, Child||Other: Care Groups Behavioral: IPT-G||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1248 participants|
|Intervention Model:||Parallel Assignment|
|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).|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Decreasing Stunting by Reducing Maternal Depression in Uganda - A Cluster Randomized Controlled Trial (CRCT) for Improved Nutrition Outcomes|
|Actual Study Start Date :||September 11, 2017|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||April 2019|
Experimental: IPT-G (Treatment arm)
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.
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.
Other Name: Interpersonal Psychotherapy for Groups
Control arm (Treatment as usual - Care Group)
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
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.
Other Name: CG
- Change in scores of KPC Survey of maternal and child health and nutrition behaviors [ Time Frame: 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). ]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).
- Score of survey on home management, referral and care seeking for children [ Time Frame: Around week 26 (end of first CG module) ]
- 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.)
- Score of survey on infant and young child feeding practices [ Time Frame: Around week 38 (end of second CG module) ]
- 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.
- Score of survey on water usage, sanitation and hygiene practices [ Time Frame: Around week 47(end of third CG module) ]
- 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.
- Score of survey on knowledge and utility of preventive services available at local health facilities [ Time Frame: Around week 56 (end of fourth CG module) ]
- 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.
- Score of survey on family planning practices [ Time Frame: Around week 65 (end of fifth CG module) ]● Whether or not mothers are using an effective method of family planning.
- PHQ-9 [ Time Frame: 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). ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03573713
|FH Uganda - Kitgum|
|Kitgum, Uganda, +256|
|Principal Investigator:||Godfrey Opiyo, B.S.||Food for the Hungry|
|Study Director:||Trisha Okenge||Food for the Hungry|