Maternal Depressive Symptom and Child DevelopmentNCT02719054
Effect of Community Based Depression Management and Child Development
A study testing Cognitive behavioral therapy: Alter of negative thinking, positive thinking and social support and psychosocial stimulation: play stimulation and parenting in people with Maternal Depressive Symptom and Child Development, run by International Centre for Diarrhoeal Disease Research, Bangladesh.
Trial summary
Investments in Early childhood Development (ECD) programs produce higher economic return through maximizing human potential. In developing countries over 200 million children do not reach their developmental potential. Read more about this study
- Who is it for?
- Ages 6 months to 1 yearHealthy volunteers can take part
- Conditions the study is for
- Maternal Depressive Symptom and Child Development
- What is being tested?
- Cognitive behavioral therapy: Alter of negative thinking, positive thinking and social support and psychosocial stimulation: play stimulation and parenting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 1 year
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Mother with depressive symptom( EPDS ≥10) with child aged 6 to 12 months
Who cannot join
- Mother with known severe chronic diseases
- Children with known severe chronic diseases
About this study
Official title: Effect of Community Based Depression Management and Psychosocial Stimulation Intervention on Maternal Mental Health and Child Development: A Randomized Controlled Trial
Investments in Early childhood Development (ECD) programs produce higher economic return through maximizing human potential. In developing countries over 200 million children do not reach their developmental potential. Early nutritional support and psycho social stimulation are essential for optimum development of children. Mothers are usually the key providers of childcare.
Depression is reported as a leading cause of disease burden for women and maternal mental health is identified as one of the major predictors of child development.
Read more
In Bangladesh, almost 60% children are at risk of poor development due to high prevalence of Low Birth Weight (22%), under nutrition (41%), poverty, and sub-optimal stimulation. About one third of Bangladeshi mothers suffer from depression. Early stimulation interventions in Bangladesh have showed moderate improvements to children's development. This indicates that there are still some gaps in the pathway to delivery. So, it is crucially important to address maternal mental health along with any Early Childhood Development intervention at community level to get bigger impact.
In Bangladesh mothers with sub clinical depressive symptoms often do not seek treatment due to the stigma attached to it. Depressed mothers who do not receive treatment often fail to provide sufficient stimulation and care for their children and in turn compromise benefits of early stimulation programs. Rahman and colleagues (2008) tested an innovative model of community-based depression management using Cognitive Behavioral Therapy in Pakistan and reported improvement in maternal depression 6 months postpartum.
The study plans to combine the above treatment of depression with an evidenced-based Early Childhood Development program to achieve maximum benefits on reducing maternal depressive symptoms as well as improving children's overall development.
Read the detailed description
Present study proposes to conduct the study in rural areas covered by community clinic (CC) services and will use their community based staff to deliver the intervention. Each Community Clinic is established at grass root level providing one stop service center for Primary Health Care for approx. 6000 population. There are over 12000 Community Clinics operating in Bangladesh. We chose this population as almost 75% of people live in rural areas and they will form a representative sample for scaling in future. There will be 2 groups in the study i) Intervention group (Cognitive Behavioral Therapy + play stimulation) and ii) control group (with none)..
Previous studies reported moderate benefit with both home and center based psycho social stimulation program in Bangladesh. However in most parts we found low self esteem among the mothers that required quite effort to bring them into the task. So it is assumed that the proposed community based Cognitive Behavioral Therapy model (Rahman et al 2008) for management of depressive symptoms, will be a unique sustainable approach to get maximize effect psycho social stimulation intervention. The study aimed to deliver the intervention using government health infrastructure. The study will evaluate the workload of existing 2 staff -Health Assistant (HA) and Family Welfare Assistant (FWA) at each Community Clinic who regularly go for home visits and will train them for intervention. The study may need to train one additional person from the same community to assist Health Assistant or Family Welfare Assistant in delivering the intervention. The overall success of the project will be able to come up with a model that can be used by other Community Clinics to take it to scale.
After selection of study sites under 30 Community Clinics, randomization will be done. The study will do several small group discussions with mothers living in those communities to know about their lifestyle, local terminologies of depressive symptoms, view about depressive symptoms, child rearing practices and coping strategies. Then Health Assistants and Family Welfare Assistants of 15 intervention Community Clinics will be identified and will receive training in batches. In next step, after taking consent, screening will be conducted in the community among mothers of 9-12 months old children by trained psychologists. Considering the Community Clinics as a center, data collectors will start screening from center to periphery in the community until we get 10 mothers with depressive symptoms. Mothers, who will fulfill the study enrollment criteria, will be offered to join the study and will be invited to the test center for baseline assessment (of mother-child dyad). We will set up temporary test centers in villages under each Community Clinic, using a space in Community Clinics (provided there is available space) or rooms in schools or convenient rented rooms in residence of local people. Two teams of testers and interviewers will be rotated from one Community Clinic to another after completing screening and baseline psychological assessments in areas under that Community Clinic which on average would take 2-3 days. It is expected that the baseline assessment will be covered by 2 months. Soon after baseline assessment in one Community Clinic, intervention in villages under that Community Clinic will be started by the trained Health Assistant/Family Welfare Assistant assigned to that Community Clinic. In the middle of the study, the study will conduct in-depth interview on two mothers under each Community Clinic to know about mothers' perception and comments about the intervention for further modification of the program. The study will also conduct small group discussions with the Health Assistant and Family Welfare Assistant about the intervention during monthly meetings with them- to know their views about the program. After 12 months intervention, final assessment will be done following the same procedure"
- Being tested
- Cognitive behavioral therapy: Alter of negative thinking, positive thinking and social support and psychosocial stimulation: play stimulation and parenting
- Keywords
- Depression, Child Development, Stimulation, CBT, Bangladesh
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral therapy: Alter of negative thinking, positive thinking and social support and psychosocial stimulation: play stimulation and parentingBehavioural
Also called CBT & PS
A:Cognitive Behavioral Therapy specifically focused on "changing thinking style toward positive" and not associated with any medication. CBT found to be effective in managing or treating not only depression, also a variety of other conditions-e.g. mood, personality, stress, eating habit, tic etc.
B: Psycho social stimulation will follow a set of culturally appropriate, semi-structured, child's age appropriate curriculum.
| Study group | Role | What they receive |
|---|---|---|
| stimulation | Experimental | Cognitive behavioral therapy for mother and play stimulation for children aged 6 to 12 months Receives: Behavioral: Cognitive behavioral therapy: Alter of negative thinking, positive thinking and social support and psychosocial stimulation: play stimulation and parenting |
| Mother child dyad | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child's cognitive, motor and language and behavioral assessment( developmental out come)
Child's cognitive, motor and language assessment using Bayley-III and behavioral assessment during test using Wolke's Behavior Rating Scale. Wolke,s Behavior Rating scale is used through observation during Bayley test. Bayley test includes cognitive, motor and language development. All outcomes will have quantitative scores and results will be made adding the scores.
Measured: At base line and change of develomental outcome after one year of intervention at end line
Depressive symptoms
Depression Scores using Edinburgh Postpartum Depression Scale (EPDS) at baseline (during screening at home) and at the end. Result will be made adding score of each questions.
Measured: At base line and change of depressive symptomatic outcome after one year of intervention at end line
Mother's self esteem
This will be assessed using adapted version of the Rosenberg Self Esteem Scale, the most widely used measure of self esteem for research purposes. It has been used previously in Bangladesh by our team as a valid instrument.
Measured: At base line and change of state of mother's self esteem after one year of intervention at end line
Family Care Indicators
This will be used to measure quality of stimulation the child received at home. FCI has been used in Bangladesh previously and showed good reliabilities
Measured: At base line and change of Family Care Indicator after one year of intervention at end line
Child care knowledge and practices
A modified questionnaire based on our previous studies (Hamadani et al. 2006; Nahar et al. 2012) will be given to mothers to assess child care practices.
Measured: At base line and change of care giver's child care knowledge and practice after one year of intervention at end line
Secondary outcomes (6)
Children's height
Children's height at baseline and at the end in test centre. Both the children of control and intervention group may have some medical problems. So as the problems are for the both groups the study results will not be much varied.
Measured: At base line and change of children's height after one year of intervention at end line.
Children's weight
Children's weight at baseline and at the end in test centre. Both the children of control and intervention group may have some medical problems. So as the problems are for the both groups the study results will not be much varied.
Measured: At base line and change of children's weight after one year of intervention at end line.
Children's Mid Upper Arm Circumference (MUAC)
Children's Mid Upper Arm Circumference (MUAC) at baseline and at the end in test center. Both the children of control and intervention group may have some medical problems. So as the problems are for the both groups the study results will not be much varied.
Measured: At base line and change of children's weight after one year of intervention at end line.
Children's Occipital Frontal Circumference
Children's Occipital Frontal Circumference at baseline and at the end in test center. Both the children of control and intervention group may have some medical problems. So as the problems are for the both groups the study results will not be much varied.
Measured: At base line and change of children's Occipital Frontal Circumference after one year of intervention at end line.
Mother's height
Mother's height at baseline and at the end in test center. Both the mothers of control and intervention group may have some medical problems. So as the problems are for the both groups the study results will not be much varied.
Measured: At base line and change of mother's height after one year of intervention at end line.
Mother's height
Mother's weight at baseline and at the end in test center. Both the mothers of control and intervention group may have some medical problems. So as the problems are for the both groups the study results will not be much varied.
Measured: At base line and change of mother's weight after one year of intervention at end line.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2016 (estimated)
- Study startJan 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (37)Papers the sponsor has linked to this study.
- Other trials for Maternal Depressive Symptom and Child DevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Sponsor type
- University, hospital or other
- Collaborators
- Bangor University, Institute of Child Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02719054
- Sponsor's protocol ID
- PR-13066
- Status last verified
- Feb 2016
- First submitted
- 2 Mar 2016
- Last updated
- 25 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: We will share data with our collaborators
Publications
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.
PubMed 17683448Engle PL, Fernald LC, Alderman H, Behrman J, O'Gara C, Yousafzai A, de Mello MC, Hidrobo M, Ulkuer N, Ertem I, Iltus S; Global Child Development Steering Group. Strategies for reducing inequalities and improving developmental outcomes for young children in low-income and middle-income countries. Lancet. 2011 Oct 8;378(9799):1339-53. doi: 10.1016/S0140-6736(11)60889-1. Epub 2011 Sep 22.
PubMed 21944378Gausia K, Hamadani JD, Islam MM, Ali M, Algin S, Yunus M, Fisher C, Oosthuizen J. Bangla translation, adaptation and piloting of Edinburgh Postnatal Depression Scale. Bangladesh Med Res Counc Bull. 2007 Dec;33(3):81-7. doi: 10.3329/bmrcb.v33i3.1138.
PubMed 18783062Grantham-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.
PubMed 9580767Grantham-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.
PubMed 17350449Hamadani 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.
PubMed 11522564Hamadani 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.
PubMed 12147372Hamadani 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.
PubMed 16988140Hamadani JD, Tofail F, Hilaly A, Huda SN, Engle P, Grantham-McGregor SM. Use of family care indicators and their relationship with child development in Bangladesh. J Health Popul Nutr. 2010 Feb;28(1):23-33. doi: 10.3329/jhpn.v28i1.4520.
PubMed 20214083Idjradinata 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.
PubMed 7678046Karasz 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.
PubMed 15652693Khan MM, Reza H. The pattern of suicide in Pakistan. Crisis. 2000;21(1):31-5. doi: 10.1027//0227-5910.21.1.31.
PubMed 10793469Khan MM, Reza H. Gender differences in nonfatal suicidal behavior in Pakistan: significance of sociocultural factors. Suicide Life Threat Behav. 1998 Spring;28(1):62-8.
PubMed 9560167Kumar V. Poisoning deaths in married women. J Clin Forensic Med. 2004 Feb;11(1):2-5. doi: 10.1016/j.jcfm.2003.10.010.
PubMed 15261005Lawrence 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.
PubMed 16452281
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Community Based Depression Management and Psychosocial Stimulation Intervention on Maternal Mental Health and Child Development: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02719054
- Acronym / sponsor ID
- PR-13066
- Keywords
- Depression, Child Development, Stimulation, CBT, Bangladesh
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, BangladeshUniversity, hospital or other
- Collaborators
- Bangor University, Institute of Child Health
- Study start
- Jan 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 25 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investments in Early childhood Development (ECD) programs produce higher economic return through maximizing human potential. In developing countries over 200 million children do not reach their developmental potential. Early nutritional support and psycho social stimulation are essential for optimum development of children. Mothers are usually the key providers of childcare.
Depression is reported as a leading cause of disease burden for women and maternal mental health is identified as one of the major predictors of child development.
In Bangladesh, almost 60% children are at risk of poor development due to high prevalence of Low Birth Weight (22%), under nutrition (41%), poverty, and sub-optimal stimulation. About one third of Bangladeshi mothers suffer from depression. Early stimulation interventions in Bangladesh have showed moderate improvements to children's development. This indicates that there are still some gaps in the pathway to delivery. So, it is crucially important to address maternal mental health along with any Early Childhood Development intervention at community level to get bigger impact.
In Bangladesh mothers with sub clinical depressive symptoms often do not seek treatment due to the stigma attached to it. Depressed mothers who do not receive treatment often fail to provide sufficient stimulation and care for their children and in turn compromise benefits of early stimulation programs. Rahman and colleagues (2008) tested an innovative model of community-based depression management using Cognitive Behavioral Therapy in Pakistan and reported improvement in maternal depression 6 months postpartum.
The study plans to combine the above treatment of depression with an evidenced-based Early Childhood Development program to achieve maximum benefits on reducing maternal depressive symptoms as well as improving children's overall development.
Detailed description
Present study proposes to conduct the study in rural areas covered by community clinic (CC) services and will use their community based staff to deliver the intervention. Each Community Clinic is established at grass root level providing one stop service center for Primary Health Care for approx. 6000 population. There are over 12000 Community Clinics operating in Bangladesh. We chose this population as almost 75% of people live in rural areas and they will form a representative sample for scaling in future. There will be 2 groups in the study i) Intervention group (Cognitive Behavioral Therapy + play stimulation) and ii) control group (with none)..
Previous studies reported moderate benefit with both home and center based psycho social stimulation program in Bangladesh. However in most parts we found low self esteem among the mothers that required quite effort to bring them into the task. So it is assumed that the proposed community based Cognitive Behavioral Therapy model (Rahman et al 2008) for management of depressive symptoms, will be a unique sustainable approach to get maximize effect psycho social stimulation intervention. The study aimed to deliver the intervention using government health infrastructure. The study will evaluate the workload of existing 2 staff -Health Assistant (HA) and Family Welfare Assistant (FWA) at each Community Clinic who regularly go for home visits and will train them for intervention. The study may need to train one additional person from the same community to assist Health Assistant or Family Welfare Assistant in delivering the intervention. The overall success of the project will be able to come up with a model that can be used by other Community Clinics to take it to scale.
After selection of study sites under 30 Community Clinics, randomization will be done. The study will do several small group discussions with mothers living in those communities to know about their lifestyle, local terminologies of depressive symptoms, view about depressive symptoms, child rearing practices and coping strategies. Then Health Assistants and Family Welfare Assistants of 15 intervention Community Clinics will be identified and will receive training in batches. In next step, after taking consent, screening will be conducted in the community among mothers of 9-12 months old children by trained psychologists. Considering the Community Clinics as a center, data collectors will start screening from center to periphery in the community until we get 10 mothers with depressive symptoms. Mothers, who will fulfill the study enrollment criteria, will be offered to join the study and will be invited to the test center for baseline assessment (of mother-child dyad). We will set up temporary test centers in villages under each Community Clinic, using a space in Community Clinics (provided there is available space) or rooms in schools or convenient rented rooms in residence of local people. Two teams of testers and interviewers will be rotated from one Community Clinic to another after completing screening and baseline psychological assessments in areas under that Community Clinic which on average would take 2-3 days. It is expected that the baseline assessment will be covered by 2 months. Soon after baseline assessment in one Community Clinic, intervention in villages under that Community Clinic will be started by the trained Health Assistant/Family Welfare Assistant assigned to that Community Clinic. In the middle of the study, the study will conduct in-depth interview on two mothers under each Community Clinic to know about mothers' perception and comments about the intervention for further modification of the program. The study will also conduct small group discussions with the Health Assistant and Family Welfare Assistant about the intervention during monthly meetings with them- to know their views about the program. After 12 months intervention, final assessment will be done following the same procedure"
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| stimulation | Experimental | Behavioral: Cognitive behavioral therapy: Alter of negative thinking, positive thinking and social support and psychosocial stimulation: play stimulation and parentingCognitive behavioral therapy for mother and play stimulation for children aged 6 to 12 months |
| Mother child dyad | No intervention | – |
Who may qualify
- Ages
- 6 months to 1 year
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Mother with depressive symptom( EPDS ≥10) with child aged 6 to 12 months
Key exclusion criteria (2 listed)
- Mother with known severe chronic diseases
- Children with known severe chronic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive behavioral therapy: Alter of negative thinking, positive thinking and social support and psychosocial stimulation: play stimulation and parentingAlso: CBT & PSA:Cognitive Behavioral Therapy specifically focused on "changing thinking style toward positive" and not associated with any medication. CBT found to be effective in managing or treating not only depression, also a variety of other conditions-e.g. mood, personality, stress, eating habit, tic etc. B: Psycho social stimulation will follow a set of culturally appropriate, semi-structured, child's age appropriate curriculum. | Behavioural | stimulation |
Primary outcome
Child's cognitive, motor and language and behavioral assessment( developmental out come)
Time frame: At base line and change of develomental outcome after one year of intervention at end line
Child's cognitive, motor and language assessment using Bayley-III and behavioral assessment during test using Wolke's Behavior Rating Scale. Wolke,s Behavior Rating scale is used through observation during Bayley test. Bayley test includes cognitive, motor and language development. All outcomes will have quantitative scores and results will be made adding the scores.
Depressive symptoms
Time frame: At base line and change of depressive symptomatic outcome after one year of intervention at end line
Depression Scores using Edinburgh Postpartum Depression Scale (EPDS) at baseline (during screening at home) and at the end. Result will be made adding score of each questions.
Mother's self esteem
Time frame: At base line and change of state of mother's self esteem after one year of intervention at end line
This will be assessed using adapted version of the Rosenberg Self Esteem Scale, the most widely used measure of self esteem for research purposes. It has been used previously in Bangladesh by our team as a valid instrument.
Family Care Indicators
Time frame: At base line and change of Family Care Indicator after one year of intervention at end line
This will be used to measure quality of stimulation the child received at home. FCI has been used in Bangladesh previously and showed good reliabilities
Child care knowledge and practices
Time frame: At base line and change of care giver's child care knowledge and practice after one year of intervention at end line
A modified questionnaire based on our previous studies (Hamadani et al. 2006; Nahar et al. 2012) will be given to mothers to assess child care practices.
6 secondary outcomes
Children's height
Time frame: At base line and change of children's height after one year of intervention at end line.
Children's weight
Time frame: At base line and change of children's weight after one year of intervention at end line.
Children's Mid Upper Arm Circumference (MUAC)
Time frame: At base line and change of children's weight after one year of intervention at end line.
Children's Occipital Frontal Circumference
Time frame: At base line and change of children's Occipital Frontal Circumference after one year of intervention at end line.
Mother's height
Time frame: At base line and change of mother's height after one year of intervention at end line.
Mother's height
Time frame: At base line and change of mother's weight after one year of intervention at end line.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2016.
- Results publication: PubMed 17683448Black 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.
- Results publication: PubMed 21944378Engle PL, Fernald LC, Alderman H, Behrman J, O'Gara C, Yousafzai A, de Mello MC, Hidrobo M, Ulkuer N, Ertem I, Iltus S; Global Child Development Steering Group. Strategies for reducing inequalities and improving developmental outcomes for young children in low-income and middle-income countries. Lancet. 2011 Oct 8;378(9799):1339-53. doi: 10.1016/S0140-6736(11)60889-1. Epub 2011 Sep 22.
- Results publication: PubMed 18783062Gausia K, Hamadani JD, Islam MM, Ali M, Algin S, Yunus M, Fisher C, Oosthuizen J. Bangla translation, adaptation and piloting of Edinburgh Postnatal Depression Scale. Bangladesh Med Res Counc Bull. 2007 Dec;33(3):81-7. doi: 10.3329/bmrcb.v33i3.1138.
- Results publication: PubMed 9580767Grantham-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.
- Results publication: PubMed 17350449Grantham-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.
- Results publication: PubMed 11522564Hamadani 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.
- Results publication: PubMed 12147372Hamadani 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.
- Results publication: PubMed 16988140Hamadani 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.
- Results publication: PubMed 20214083Hamadani JD, Tofail F, Hilaly A, Huda SN, Engle P, Grantham-McGregor SM. Use of family care indicators and their relationship with child development in Bangladesh. J Health Popul Nutr. 2010 Feb;28(1):23-33. doi: 10.3329/jhpn.v28i1.4520.
- Results publication: PubMed 7678046Idjradinata 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.
- Results publication: PubMed 15652693Karasz 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.
- Results publication: PubMed 10793469Khan MM, Reza H. The pattern of suicide in Pakistan. Crisis. 2000;21(1):31-5. doi: 10.1027//0227-5910.21.1.31.
- Individual participant dataSharing planned: Yes. We will share data with our collaborators
Related trials for Maternal Depressive Symptom and Child Development
Not yet recruiting
Mental Health Support Interventions for Mothers of Infants and Young Children
Maternal Mental Health, Early Child Development
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavioral therapy: Alter of negative thinking, positive thinking and social support and psychosocial stimulation: play stimulation and parenting in people with Maternal Depressive Symptom and Child Development, run by International Centre for Diarrhoeal Disease Research, Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child's cognitive, motor and language and behavioral assessment( developmental out come) (time frame: At base line and change of develomental outcome after one year of intervention at end line). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02719054, which also lists 37 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2016.