Reduce Childhood Maltreatment and Promote Development

NCT03031236 | Completed

• 1 other identifier: PR-15002
• Study Type: interventional
• Target: 306
• Locations: 1 country
• Sites: 1

Brief Summary

Background (brief):

• Children's cognitive, motor, language and socio-emotional development; anthropometry; hemoglobin and micro-nutrient status (serum vitamin B12, iron and folic acid)
• Mother s' parenting practices, depressive symptoms, self-esteem and child-maltreatment.

Conditions

Maltreatment

Keywords

Early Childhood Development (ECD); Psychosocial stimulation; Cognition; Parenting; Malnutrition; Bangladesh; Childhood Maltreatment

Outcome Measures

Primary Outcomes (1)

• Cognitive development (composite score of cognitive,motor, language and social-emotional development of children)

  cognitive development will be measured by Bayley tools. All individuals score will be aggregated in to composite score of cognitive,motor, language and social-emotional development of children

  Change from baseline at 11 months of intervention

Secondary Outcomes (11)

• Maltreatment of children by the caregivers

  Change from baseline at 11 months of intervention

• Height

  Change from baseline at 11 months of intervention

• Weight

  Change from baseline at 11 months of intervention

• Head circumference

  Change from baseline at 11 months of intervention

• Haemoglobin

  Change from baseline at 11 months of intervention

Study Arms (2)

ECD+

ACTIVE COMPARATOR

Behavioral: Psychosocial stimulation, Cognitive behavioral therapy and positive parenting practice The mothers of intervention (ECD+HN) group will receive fortnightly group sessions for 12 months that will include combined messages on a) psychosocial stimulation, b) positive parenting to prevent child maltreatment and c) cognitive behavioural therapy (CBT) for positive thinking, d) health and nutrition messages and e) 15 micronutrient sprinkle supplement.(90 sachets of over 6 month-period)

Behavioral: Psychosocial stimulation, Cognitive behavioral therapy and positive parenting practice

Only regular health messages

NO INTERVENTION

Only regular health message from government health services

Interventions

Psychosocial stimulation, Cognitive behavioral therapy and positive parenting practice BEHAVIORAL

The mothers of intervention (ECD+HN) group will receive fortnightly group sessions for 12 months that will include combined messages on a) psychosocial stimulation, b) positive parenting to prevent child maltreatment and c) cognitive behavioural therapy (CBT) for positive thinking, d) health and nutrition messages and e) 15 micronutrient sprinkle supplement.(90 sachets of over 6 month-period)

ECD+

Eligibility Criteria

• Age: 8 Months - 23 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Mothers of 8 to 23 months old children, who practice maltreatment or harsh child-discipline (screened by a previously used tool), will be included.
• Children 8-23 months old with weight-for-length ≥-3 z score, MUAC ≥ 115 mm
• Mothers are the primary caregivers and consented to participate.

You may not qualify if:

• severe malnutrition nutritional edema, known developmental disability, chronic illness, haemoglobin level \<8 gm/L (at enrolment). They will be referred to the nearby health facilities for necessary clinical management

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead
• UBS Optimus Foundation: collaborator

Study Sites (1)

Fahmida Tofail, PhD

Dhaka, Bangladesh

Location

Related Publications (27)

• Black MM, Baqui AH, Zaman K, El Arifeen S, Black RE. Maternal depressive symptoms and infant growth in rural Bangladesh. Am J Clin Nutr. 2009 Mar;89(3):951S-957S. doi: 10.3945/ajcn.2008.26692E. Epub 2009 Jan 28.

  PMID: 19176729 BACKGROUND

• Black MM, Baqui AH, Zaman K, McNary SW, Le K, Arifeen SE, Hamadani JD, Parveen M, Yunus M, Black RE. Depressive symptoms among rural Bangladeshi mothers: implications for infant development. J Child Psychol Psychiatry. 2007 Aug;48(8):764-72. doi: 10.1111/j.1469-7610.2007.01752.x.

  PMID: 17683448 BACKGROUND

• Arsenault JE, Yakes EA, Islam MM, Hossain MB, Ahmed T, Hotz C, Lewis B, Rahman AS, Jamil KM, Brown KH. Very low adequacy of micronutrient intakes by young children and women in rural Bangladesh is primarily explained by low food intake and limited diversity. J Nutr. 2013 Feb;143(2):197-203. doi: 10.3945/jn.112.169524. Epub 2012 Dec 19.

  PMID: 23256144 BACKGROUND

• Beck CT. Maternal depression and child behaviour problems: a meta-analysis. J Adv Nurs. 1999 Mar;29(3):623-9. doi: 10.1046/j.1365-2648.1999.00943.x.

  PMID: 10210459 BACKGROUND

• Caldwell BM. Descriptive evaluations of child development and of developmental settings. Pediatrics. 1967 Jul;40(1):46-54. No abstract available.

  PMID: 6028898 BACKGROUND

• Grantham-McGregor S; International Child Development Committee. Early child development in developing countries. Lancet. 2007 Mar 10;369(9564):824. doi: 10.1016/S0140-6736(07)60404-8. No abstract available.

  PMID: 17350449 BACKGROUND

• Grantham-McGregor SM, Lira PI, Ashworth A, Morris SS, Assuncao AM. The development of low birth weight term infants and the effects of the environment in northeast Brazil. J Pediatr. 1998 Apr;132(4):661-6. doi: 10.1016/s0022-3476(98)70357-9.

  PMID: 9580767 BACKGROUND

• Hamadani JD, Fuchs GJ, Osendarp SJ, Khatun F, Huda SN, Grantham-McGregor SM. Randomized controlled trial of the effect of zinc supplementation on the mental development of Bangladeshi infants. Am J Clin Nutr. 2001 Sep;74(3):381-6. doi: 10.1093/ajcn/74.3.381.

  PMID: 11522564 BACKGROUND

• Hamadani JD, Fuchs GJ, Osendarp SJ, Huda SN, Grantham-McGregor SM. Zinc supplementation during pregnancy and effects on mental development and behaviour of infants: a follow-up study. Lancet. 2002 Jul 27;360(9329):290-4. doi: 10.1016/S0140-6736(02)09551-X.

  PMID: 12147372 BACKGROUND

• Hamadani JD, Huda SN, Khatun F, Grantham-McGregor SM. Psychosocial stimulation improves the development of undernourished children in rural Bangladesh. J Nutr. 2006 Oct;136(10):2645-52. doi: 10.1093/jn/136.10.2645.

  PMID: 16988140 BACKGROUND

• Walker SP, Wachs TD, Grantham-McGregor S, Black MM, Nelson CA, Huffman SL, Baker-Henningham H, Chang SM, Hamadani JD, Lozoff B, Gardner JM, Powell CA, Rahman A, Richter L. Inequality in early childhood: risk and protective factors for early child development. Lancet. 2011 Oct 8;378(9799):1325-38. doi: 10.1016/S0140-6736(11)60555-2. Epub 2011 Sep 22.

  PMID: 21944375 BACKGROUND

• Idjradinata P, Pollitt E. Reversal of developmental delays in iron-deficient anaemic infants treated with iron. Lancet. 1993 Jan 2;341(8836):1-4. doi: 10.1016/0140-6736(93)92477-b.

  PMID: 7678046 BACKGROUND

• Karasz A. Cultural differences in conceptual models of depression. Soc Sci Med. 2005 Apr;60(7):1625-35. doi: 10.1016/j.socscimed.2004.08.011.

  PMID: 15652693 BACKGROUND

• Khan MM, Reza H. The pattern of suicide in Pakistan. Crisis. 2000;21(1):31-5. doi: 10.1027//0227-5910.21.1.31.

  PMID: 10793469 BACKGROUND

• Kumar V. Poisoning deaths in married women. J Clin Forensic Med. 2004 Feb;11(1):2-5. doi: 10.1016/j.jcfm.2003.10.010.

  PMID: 15261005 BACKGROUND

• Lawrence V, Murray J, Banerjee S, Turner S, Sangha K, Byng R, Bhugra D, Huxley P, Tylee A, Macdonald A. Concepts and causation of depression: a cross-cultural study of the beliefs of older adults. Gerontologist. 2006 Feb;46(1):23-32. doi: 10.1093/geront/46.1.23.

  PMID: 16452281 BACKGROUND

• Lind T, Lonnerdal B, Stenlund H, Gamayanti IL, Ismail D, Seswandhana R, Persson LA. A community-based randomized controlled trial of iron and zinc supplementation in Indonesian infants: effects on growth and development. Am J Clin Nutr. 2004 Sep;80(3):729-36. doi: 10.1093/ajcn/80.3.729.

  PMID: 15321815 BACKGROUND

• Lovejoy MC, Graczyk PA, O'Hare E, Neuman G. Maternal depression and parenting behavior: a meta-analytic review. Clin Psychol Rev. 2000 Aug;20(5):561-92. doi: 10.1016/s0272-7358(98)00100-7.

  PMID: 10860167 BACKGROUND

• Murray L, Cooper P. Effects of postnatal depression on infant development. Arch Dis Child. 1997 Aug;77(2):99-101. doi: 10.1136/adc.77.2.99. No abstract available.

  PMID: 9301345 BACKGROUND

• Nasreen HE, Kabir ZN, Forsell Y, Edhborg M. Impact of maternal depressive symptoms and infant temperament on early infant growth and motor development: results from a population based study in Bangladesh. J Affect Disord. 2013 Apr 5;146(2):254-61. doi: 10.1016/j.jad.2012.09.013. Epub 2012 Oct 11.

  PMID: 23063237 BACKGROUND

• Patel V, Rahman A, Jacob KS, Hughes M. Effect of maternal mental health on infant growth in low income countries: new evidence from South Asia. BMJ. 2004 Apr 3;328(7443):820-3. doi: 10.1136/bmj.328.7443.820.

  PMID: 15070641 BACKGROUND

• Pollitt E, Saco-Pollitt C, Jahari A, Husaini MA, Huang J. Effects of an energy and micronutrient supplement on mental development and behavior under natural conditions in undernourished children in Indonesia. Eur J Clin Nutr. 2000 May;54 Suppl 2:S80-90. doi: 10.1038/sj.ejcn.1601009.

  PMID: 10902991 BACKGROUND

• Raj A, Silverman JG. Intimate partner violence against South Asian women in greater Boston. J Am Med Womens Assoc (1972). 2002 Spring;57(2):111-4.

  PMID: 11991419 BACKGROUND

• Schellenberg JA, Victora CG, Mushi A, de Savigny D, Schellenberg D, Mshinda H, Bryce J; Tanzania Integrated Management of Childhood Illness MCE Baseline Household Survey Study Group. Inequities among the very poor: health care for children in rural southern Tanzania. Lancet. 2003 Feb 15;361(9357):561-6. doi: 10.1016/S0140-6736(03)12515-9.

  PMID: 12598141 BACKGROUND

• Segre LS, Stasik SM, O'Hara MW, Arndt S. Listening visits: an evaluation of the effectiveness and acceptability of a home-based depression treatment. Psychother Res. 2010 Nov;20(6):712-21. doi: 10.1080/10503307.2010.518636.

  PMID: 21154029 BACKGROUND

• Tofail F, Hamadani JD, Mehrin F, Ridout DA, Huda SN, Grantham-McGregor SM. Psychosocial stimulation benefits development in nonanemic children but not in anemic, iron-deficient children. J Nutr. 2013 Jun;143(6):885-93. doi: 10.3945/jn.112.160473. Epub 2013 Apr 24.

  PMID: 23616511 BACKGROUND

• Tsutsumi A, Izutsu T, Akramul Islam MD, Amed JU, Nakahara S, Takagi F, Wakai S. Depressive status of leprosy patients in Bangladesh: association with self-perception of stigma. Lepr Rev. 2004 Mar;75(1):57-66.

  PMID: 15072127 BACKGROUND

Related Links

• Uddin MK, Islam MT, Asaduzzaman M. Perceived Stress and Self-Esteem as Significant Predictors of Cigarette Smoking Behavior of Bangladeshi Male Adults.

MeSH Terms

Conditions

Malnutrition

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Fahmida Tofail, PhD

  International Centre for Diarrhoeal Disease Research, Bangladesh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2016
• First Posted: January 25, 2017
• Study Start: May 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 25, 2017

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)