Joanna Maselko1, Siham Sikander2, Sonia Bhalotra3, Omer Bangash2, Nima Ganga4, Satadru Mukherjee3, Helen Egger5, Lauren Franz6, Amina Bibi2, Rakhshanda Liaqat2, Misbah Kanwal2, Tayyaba Abbasi2, Maryam Noor2, Nida Ameen2, Atif Rahman7. 1. Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA; Duke Global Health Institute, Duke University Medical Center, Durham, NC, USA. Electronic address: joanna.maselko@dm.duke.edu. 2. Human Development Research Foundation, Islamabad, Pakistan. 3. Department of Economics and Institute of Social and Economic Research, University of Essex, Colchester, UK. 4. Duke Global Health Institute, Duke University Medical Center, Durham, NC, USA. 5. Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA. 6. Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA; Duke Global Health Institute, Duke University Medical Center, Durham, NC, USA. 7. Institute of Psychology, Health, and Society, University of Liverpool, Liverpool, UK.
Abstract
BACKGROUND: Perinatal depression has been linked with deleterious child development outcomes, yet maternal depression interventions have not been shown to have lasting effects on child development, and evidence is not available from countries of low or middle income. In the Thinking Healthy Programme cluster-randomised controlled trial, a perinatal depression intervention was assessed in Pakistan in 2006-07. The intervention significantly reduced depression levels 12 months post partum compared with a control. We aimed to assess the effect of this same intervention on the cognitive, socioemotional, and physical development of children at around age 7 years. METHODS:Mother-child dyads who participated in the Thinking Healthy Programme cluster-randomised controlled trial were interviewed when the index child was about 7 years old. A reference group of 300 mothers who did not have prenatal depression and, therefore, did not receive the original intervention, was enrolled with their children at the same time. The primary cognitive outcome was the score on the Wechsler Preschool and Primary Scale of Intelligence (WPPSI-IV); primary socioemotional outcomes included scores on the Strengths and Difficulties Questionnaire (SDQ) and the Spence Children's Anxiety Scale (SCAS); and primary physical outcomes were height-for-age, weight-for-age, and body-mass index (BMI)-for-age Z scores. Generalised linear modelling with random effects to account for clustering was the main method of analysis. Analyses were by intention to treat. The Thinking Healthy Programme cluster-randomised trial was registered at ISRCTN.com, number ISRCTN65316374. FINDINGS: Of 705 participating mother-child dyads interviewed at the end of the Thinking Healthy Programme randomised controlled trial, 584 (83%) dyads were enrolled. 289 mothers had received the intervention and 295 had received acontrol consisting of enhanced usual care. The mean age of the children was 7·6 years (SD 0·1). Overall, cognitive, socioemotional, or physical development outcomes did not differ between children in the intervention or control groups whose mothers had prenatal depression. When compared with the reference group of children whose mothers did not have prenatal depression, the Thinking Healthy Programme trial children had worse socioemotional outcomes; mean scores were significantly higher on the SDQ for total difficulty (11·34 vs 10·35; mean difference 0·78, 95% CI 0·09-1·47; p=0·03) and on the SCAS for anxiety (21·33 vs 17·57; mean difference 2·93, 1·15-4·71; p=0·0013). Cognitive and physical outcomes did not differ. INTERPRETATION: Our findings show that cognitive, socioemotional, and physical developmental outcomes of children at age 7 years whose mother had prenatal depression did not differ between those who received the Thinking Healthy Programme intervention and those who received the control. Further investigation is needed to understand what types of complex interventions or approaches are needed for long-term gains in maternal and child wellbeing. Prolonged, detailed, and frequent follow-up is warranted for all interventions. FUNDING: Grand Challenges Canada (Government of Canada), Saving Brains programme.
RCT Entities:
BACKGROUND: Perinatal depression has been linked with deleterious child development outcomes, yet maternal depression interventions have not been shown to have lasting effects on child development, and evidence is not available from countries of low or middle income. In the Thinking Healthy Programme cluster-randomised controlled trial, a perinatal depression intervention was assessed in Pakistan in 2006-07. The intervention significantly reduced depression levels 12 months post partum compared with a control. We aimed to assess the effect of this same intervention on the cognitive, socioemotional, and physical development of children at around age 7 years. METHODS: Mother-child dyads who participated in the Thinking Healthy Programme cluster-randomised controlled trial were interviewed when the index child was about 7 years old. A reference group of 300 mothers who did not have prenatal depression and, therefore, did not receive the original intervention, was enrolled with their children at the same time. The primary cognitive outcome was the score on the Wechsler Preschool and Primary Scale of Intelligence (WPPSI-IV); primary socioemotional outcomes included scores on the Strengths and Difficulties Questionnaire (SDQ) and the Spence Children's Anxiety Scale (SCAS); and primary physical outcomes were height-for-age, weight-for-age, and body-mass index (BMI)-for-age Z scores. Generalised linear modelling with random effects to account for clustering was the main method of analysis. Analyses were by intention to treat. The Thinking Healthy Programme cluster-randomised trial was registered at ISRCTN.com, number ISRCTN65316374. FINDINGS: Of 705 participating mother-child dyads interviewed at the end of the Thinking Healthy Programme randomised controlled trial, 584 (83%) dyads were enrolled. 289 mothers had received the intervention and 295 had received a control consisting of enhanced usual care. The mean age of the children was 7·6 years (SD 0·1). Overall, cognitive, socioemotional, or physical development outcomes did not differ between children in the intervention or control groups whose mothers had prenatal depression. When compared with the reference group of children whose mothers did not have prenatal depression, the Thinking Healthy Programme trial children had worse socioemotional outcomes; mean scores were significantly higher on the SDQ for total difficulty (11·34 vs 10·35; mean difference 0·78, 95% CI 0·09-1·47; p=0·03) and on the SCAS for anxiety (21·33 vs 17·57; mean difference 2·93, 1·15-4·71; p=0·0013). Cognitive and physical outcomes did not differ. INTERPRETATION: Our findings show that cognitive, socioemotional, and physical developmental outcomes of children at age 7 years whose mother had prenatal depression did not differ between those who received the Thinking Healthy Programme intervention and those who received the control. Further investigation is needed to understand what types of complex interventions or approaches are needed for long-term gains in maternal and child wellbeing. Prolonged, detailed, and frequent follow-up is warranted for all interventions. FUNDING: Grand Challenges Canada (Government of Canada), Saving Brains programme.
Authors: Mark Tomlinson; Mary Jane Rotheram-Borus; Ingrid M le Roux; Maryann Youssef; Sandahl H Nelson; Aaron Scheffler; Robert E Weiss; Mary O'Connor; Carol M Worthman Journal: Prev Sci Date: 2016-11
Authors: Joanna Maselko; Siham Sikander; Elizabeth L Turner; Lisa M Bates; Ikhlaq Ahmad; Najia Atif; Victoria Baranov; Sonia Bhalotra; Amina Bibi; Tayyaba Bibi; Samina Bilal; Pietro Biroli; Esther Chung; John A Gallis; Ashley Hagaman; Anam Jamil; Katherine LeMasters; Karen O'Donnell; Elissa Scherer; Maria Sharif; Ahmed Waqas; Ahmed Zaidi; Shaffaq Zulfiqar; Atif Rahman Journal: Lancet Psychiatry Date: 2020-09 Impact factor: 27.083
Authors: Elizabeth L Turner; Siham Sikander; Omer Bangash; Ahmed Zaidi; Lisa Bates; John Gallis; Nima Ganga; Karen O'Donnell; Atif Rahman; Joanna Maselko Journal: Trials Date: 2016-09-08 Impact factor: 2.279