Effects of Light Exposure for Postpartum Depression on Infant Development (Chrono_Baby)

The Impact of Non-Pharmacological Treatment (Exposure to Light) for Postpartum Depression on Infant Growth and Development

About 11% of women develop depression and anxiety after giving birth. These symptoms can reduce a mother's quality of life and daily functioning and may negatively affect her child's growth and development. Blue light therapy, based on chronobiology principles, has shown promising results for treating postpartum depression. It is relatively low-cost and has no known side effects. However, it is still unclear whether treating mothers with blue light therapy improves their children's growth and development. This study will investigate whether infants of mothers treated with blue light therapy for postpartum depression show better growth and developmental outcomes during their first year of life. Mothers diagnosed with postpartum depression within the first six weeks after childbirth will be assigned to one of two light exposure groups: a therapeutic blue light group or a control light exposure group (from another research study NCT06246214). A third group will include mothers without postpartum depression, and a fourth with previous depression. Children will be followed until 12 months of age. At that time, researchers will assess their growth, nutrition, and developmental milestones. The main goal is to compare child growth and development across these groups using statistical analyses.

Study Overview

• Status: Enrolling by invitation
• Conditions: Nutrition; Development and Health

Detailed Description

Currently, it is estimated that approximately 11% of women develop mood disorders in the postpartum period, presenting symptoms of both depression and anxiety, which are associated with a worsened quality of life and reduced maternal functioning. Postpartum depression has an impact on child health, directly and indirectly affecting growth and development.

Studies evaluating blue light exposure treatment, based on principles of chronobiology, are still scarce; however, some have reported promising results, in addition to lower cost and absence of side effects. Nevertheless, the impact of this maternal intervention on child growth and development remains unknown.

The hypothesis of the present project is that children born to mothers treated with blue light exposure for postpartum depression will show better growth and development during the first year of life. Accordingly, the aim of this study is to evaluate the growth and development of children born to mothers under these conditions: Mothers diagnosed with postpartum depression up to the infant's sixth week of life will be allocated to two light-exposure therapy groups (an intervention/therapeutic group and a control light-exposure group from another research study - NCT06246214), in addition to a control group of mothers without postpartum depression and a group with previous depression.

Children will be followed until 12 months of age, at which point multiple nutritional, growth, and developmental measures will be collected.

Data analyses will be conducted using association tests and linear regression models, with child growth and developmental outcomes as the primary endpoints.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• Brazil
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90410-000
      • Hospital De Clinicas De Porto Alegre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Infants born to women 18 years or older, who speak fluent Portuguese and are 4 to 6 weeks postpartum, will participate.

Description

Inclusion Criteria:

• All eligible children born to mothers diagnosed with PPD up to six weeks postpartum and randomized into two light therapy groups (intervention and control), with an additional control group of mothers without a diagnosis of PPD. These mothers are being randomized in another study (Identifier NCT06246214 at ClinicalTrials.gov). Children born to mothers diagnosed with depression in the last year will enter the study as a fourth group.

Exclusion Criteria:

• Late preterm newborns (gestational age < 33 weeks)
• Adverse peri- and neonatal outcomes:
• periventricular hemorrhage,
• leukomalacia,
• cardiorespiratory arrest,
• resuscitation,
• mechanical ventilation,
• genetic syndromes
• congenital malformations
• Vertical HIV exposure.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Infants of PPD mothers treated with blue light therapy; Infants of mothers with postpartum depression symptoms who received blue light therapy at one month postpartum
Infants of PPD mothers treated with control light therapy; Infants of mothers with postpartum depression symptoms who received control light therapy at one month postpartum
Infants of mothers with no postpartum depression symptoms
Infants of depressive mothers; Infants of mothers with depression prior to birth

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infant Development - Bayley	The Bayley Scale of Infant and Toddler Development - 4th Edition (BSITD-4; Bayley, 2019). Bayley Scale is recognized as a gold-standard tool for assessing child development and identifying developmental delays across five domains: cognitive, language, motor, social-emotional, and adaptive behavior (Bayley & Aylward, 2019). The cognitive, language, and motor domains involve structured activities administered to the child, with caregiver involvement as needed. The social-emotional and adaptive behavior domains are assessed via caregiver questionnaires. The BSITD-4 scoring is age-based, with a specific starting point for each domain. Raw scores are summed and scaled, and composite scores are calculated. Composite scores classify performance as: Very superior (>130), superior (120-129), high average (110-119), average (90-109), low average (80-89), borderline (70-79), or extremely Low (<69).	At 1 to 1.5 months of age.
Change from Baseline in Infant Development - Bayley	The Bayley Scale of Infant and Toddler Development - 4th Edition (BSITD-4; Bayley, 2019). Bayley Scale is recognized as a gold-standard tool for assessing child development and identifying developmental delays across five domains: cognitive, language, motor, social-emotional, and adaptive behavior (Bayley & Aylward, 2019). The cognitive, language, and motor domains involve structured activities administered to the child, with caregiver involvement as needed. The social-emotional and adaptive behavior domains are assessed via caregiver questionnaires. The BSITD-4 scoring is age-based, with a specific starting point for each domain. Raw scores are summed and scaled, and composite scores are calculated. Composite scores classify performance as: Very superior (>130), superior (120-129), high average (110-119), average (90-109), low average (80-89), borderline (70-79), or extremely Low (<69).	At 6 months of age.
Change from Baseline in Infant Development - Bayley	The Bayley Scale of Infant and Toddler Development - 4th Edition (BSITD-4; Bayley, 2019). Bayley Scale is recognized as a gold-standard tool for assessing child development and identifying developmental delays across five domains: cognitive, language, motor, social-emotional, and adaptive behavior (Bayley & Aylward, 2019). The cognitive, language, and motor domains involve structured activities administered to the child, with caregiver involvement as needed. The social-emotional and adaptive behavior domains are assessed via caregiver questionnaires. The BSITD-4 scoring is age-based, with a specific starting point for each domain. Raw scores are summed and scaled, and composite scores are calculated. Composite scores classify performance as: Very superior (>130), superior (120-129), high average (110-119), average (90-109), low average (80-89), borderline (70-79), or extremely Low (<69).	At 12 months of age.
Infant Development - DIACD	The Dimensional Inventory for the Assessment of Child Development (DIACD; Silva et al., 2019, 2020), developed and validated for Brazilian children (de Mendonça et al., 2021; Miranda et al., 2020; Silva et al., 2020), is a multidimensional parental proxy report to identify potential developmental delays in children aged 4 to 72 months. The inventory is organized in seven domains: Cognitive, Socioemotional, Receptive Language and Communication, Expressive Language and Communication, Gross Motor, Fine Motor, and Adaptive Behavior. The DIACD takes about 30 minutes. Analyses examining evidence of reliability found values ranging from 0.97 to 0.99 for responses across domains. The standardized score has a mean of 100 and a standard deviation of 15. Children are classified as well above age expectations (>130), above age expectations (123-130), typical development (85-116), risk of developmental delay (78-84), developmental delay (70-77), and significant developmental delay (<70).	At 6 months of age
Change of Baseline in Infant Development - DIACD	The Dimensional Inventory for the Assessment of Child Development (DIACD; Silva et al., 2019, 2020), developed and validated for Brazilian children (de Mendonça et al., 2021; Miranda et al., 2020; Silva et al., 2020), is a multidimensional parental proxy report to identify potential developmental delays in children aged 4 to 72 months. The inventory is organized in seven domains: Cognitive, Socioemotional, Receptive Language and Communication, Expressive Language and Communication, Gross Motor, Fine Motor, and Adaptive Behavior. The DIACD takes about 30 minutes. Analyses examining evidence of reliability found values ranging from 0.97 to 0.99 for responses across domains. The standardized score has a mean of 100 and a standard deviation of 15. Children are classified as well above age expectations (>130), above age expectations (123-130), typical development (85-116), risk of developmental delay (78-84), developmental delay (70-77), and significant developmental delay (<70).	At 12 months of age.
Anthropometric Measures of Infant Growth	Infant weight, length, and head circumference, chest circumference, and body fat will be obtained by trained researchers during in-person visits, and the nutritional status will be calculated using the Anthro® software from the Brazilian Ministry of Health. Data will be collected in duplicate or triplicate by trained researchers using standardized protocols, with the average value recorded.	At 1 to 1.5 months of age.
Change from Baseline in Anthropometric Measures of Infant Growth	Infant weight, length, and head circumference, chest circumference, and body fat will be obtained by trained researchers during in-person visits, and the nutritional status will be calculated using the Anthro® software from the Brazilian Ministry of Health. Data will be collected in duplicate or triplicate by trained researchers using standardized protocols, with the average value recorded.	At 6 months of age.
Change from Baseline in Anthropometric Measures of Infant Growth	Infant weight, length, and head circumference, chest circumference, and body fat will be obtained by trained researchers during in-person visits, and the nutritional status will be calculated using the Anthro® software from the Brazilian Ministry of Health. Data will be collected in duplicate or triplicate by trained researchers using standardized protocols, with the average value recorded.	At 12 months of age.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breastfeeding Self-Efficacy - BSES	Mothers will also be assessed with respect to their beliefs, expectations, knowledge, and ability to breastfeed successfully. To address this goal, the Breastfeeding Self-Efficacy Scale (BSES; Dennis & Faux, 1999), validated for the Brazilian population (Oriá & Ximenes, 2010), will be used. The BSES is organized into four informational sources: personal experience, verbal persuasion, vicarious experience, and emotional/physiological state. The BSES is a self-administered questionnaire composed of 33 items rated on a 5-point Likert scale (range from strongly agree to "strongly disagree). Total scores (ranging from 33 to 165) are provided; higher scores reflect confidence in breastfeeding ability	At 1 to 1.5 months of age.
Infant feeding practices - BEBQ	Infant feeding practices measured by the Baby Eating Behavior Questionnaire (BEBQ: Lucion et al., 2017).) validated for the Brazilian population. This questionnaire examines specific appetite traits in children (ages 0 to 12 months), before the introduction of solid foods, within four domains: enjoyment of food, food responsiveness, speed of eating, and satiety responsiveness. The BEBQ is a self-administered instrument comprising 18 items and can be used regardless of breastfeeding type. Scale scores are the means of all scale items. Higher scores indicate more frequent demonstrations of behaviors characterizing the domain.	At 6 months of age.
Infant feeding practices - CEBQ	The Children's Eating Behavior Questionnaire (CEBQ; Wardle et al., 2001), validated for the Brazilian population (Viana, Sinde & Saxton, 2008), will be used to assess the eating behavior of children at 12 months; the mothers will complete the questionnaire. This is a self-administered instrument consisting of 35 items, in two dimensions: Food Avoidance assessed throughout four subscales (e.g., Satiety Responsiveness, Slowness in Eating, Food Fussiness, and Emotional Under-Eating) and Food Approach also assessed with four subscales (Food Responsiveness, Enjoyment of Food, Emotional Over-Eating, and Desire to Drink). Responses are provided on a 5-point Likert scale ranging from "never" to "always. Scale scores are the means of all scale items. Higher scores indicate more frequent demonstrations of behaviors characterizing the subscales.	At 12 months of age.
Infant sleep problems - BISQ	The Brief Infant Sleep Questionnaire (BISQ; Sadeh, 2004) will be used to screen children sleep problems. The BISQ was developed in children aged 0 to 3 years. It is a semi-structured questionnaire consisting of 12 items related to the child's sleep in the past week, completed by parents or caregivers. It takes about 10 minutes to complete. Its validity and reliability were originally confirmed by comparisons with actigraphy and sleep diaries (Sadeh, 2004). The instrument was translated into Brazilian Portuguese by Nunes et al. (2012) and validated in a Brazilian study showing high specificity for sleep-related parameters, supporting parental reports for epidemiological research (Dal-Ponte et al., 2020). The criteria used to define poor sleepers based on the BISQ measures are as follows: 1) the child wakes > 3 times per night; 2) the nocturnal wakefulness period is > 1 hour; or 3) the total sleep time is < 9 hours.	At 6 months of age.
Change from Baseline in Infant sleep problems - BISQ	The Brief Infant Sleep Questionnaire (BISQ; Sadeh, 2004) will be used to screen children sleep problems. The BISQ was developed in children aged 0 to 3 years. It is a semi-structured questionnaire consisting of 12 items related to the child's sleep in the past week, completed by parents or caregivers. It takes about 10 minutes to complete. Its validity and reliability were originally confirmed by comparisons with actigraphy and sleep diaries (Sadeh, 2004). The instrument was translated into Brazilian Portuguese by Nunes et al. (2012) and validated in a Brazilian study showing high specificity for sleep-related parameters, supporting parental reports for epidemiological research (Dal-Ponte et al., 2020). The criteria used to define poor sleepers based on the BISQ measures are as follows: 1) the child wakes > 3 times per night; 2) the nocturnal wakefulness period is > 1 hour; or 3) the total sleep time is < 9 hours.	At 12 months of age.
Mother-infant interaction quality - Dyadic Interaction Assessment Protocol	The Dyadic Interaction Assessment Protocol (DIAP) is a bidirectional measure of adult-child interaction based on Ainsworth and Cox and validated in Brazil. It involves a standardized seven-minute free-play task in which caregiver-child behavior is coded across ten categories grouped into dyadic characteristics (child engagement with the environment, interaction with the caregiver, positive and negative affect, and caregiver sensitivity and intrusiveness) and adult characteristics (positive and negative affect, cognitive stimulation, and disengagement). The instrument demonstrates strong psychometric properties, including adequate interrater reliability, internal consistency, and convergent validity. Sessions follow the original free-play procedure with mother and infant, are video recorded with caregiver consent, coded by trained raters blinded to study variables using standardized guidelines, and disagreements are resolved by a third independent evaluator to ensure coding reliability	At 6 months of age.
Change from Baseline in Mother-infant interaction quality - Dyadic Interaction Assessment Protocol	The Dyadic Interaction Assessment Protocol (DIAP) is a bidirectional measure of adult-child interaction based on Ainsworth and Cox and validated in Brazil. It involves a standardized seven-minute free-play task in which caregiver-child behavior is coded across ten categories grouped into dyadic characteristics (child engagement with the environment, interaction with the caregiver, positive and negative affect, and caregiver sensitivity and intrusiveness) and adult characteristics (positive and negative affect, cognitive stimulation, and disengagement). The instrument demonstrates strong psychometric properties, including adequate interrater reliability, internal consistency, and convergent validity. Sessions follow the original free-play procedure with mother and infant, are video recorded with caregiver consent, coded by trained raters blinded to study variables using standardized guidelines, and disagreements are resolved by a third independent evaluator to ensure coding reliability	At 12 months of age.
Mother-infant interaction quality - The Interaction Rating Scale (IRS)	The Interaction Rating Scale (IRS) assesses caregiver-child interaction in children aged 0-8 years through a structured five-minute observation. It comprises 70 dichotomous behavioral items and 11 impression items rated on a five-point scale, organized into ten factors representing child skills (autonomy, responsiveness, empathy, motor and emotional regulation) and caregiver behaviors (respect for autonomy, responsiveness, empathy, and cognitive and socioemotional support). A total score summarizes overall interaction quality. The IRS is currently undergoing validation in Brazil and, in its original version, demonstrated high interrater reliability and adequate to strong internal consistency. In this study, coding will rely on seven-minute free-play videos, be conducted independently by two trained raters, and discrepancies will be resolved by a third evaluator following standardized training procedures to ensure reliability.	At 6 months of age.
15. Change from Baseline in Mother-infant interaction quality - The Interaction Rating Scale (IRS)	The Interaction Rating Scale (IRS) assesses caregiver-child interaction in children aged 0-8 years through a structured five-minute observation. It comprises 70 dichotomous behavioral items and 11 impression items rated on a five-point scale, organized into ten factors representing child skills (autonomy, responsiveness, empathy, motor and emotional regulation) and caregiver behaviors (respect for autonomy, responsiveness, empathy, and cognitive and socioemotional support). A total score summarizes overall interaction quality. The IRS is currently undergoing validation in Brazil and, in its original version, demonstrated high interrater reliability and adequate to strong internal consistency. In this study, coding will rely on seven-minute free-play videos, be conducted independently by two trained raters, and discrepancies will be resolved by a third evaluator following standardized training procedures to ensure reliability.	At 12 months of age.
Infant screen exposure	A Portuguese-adapted version of the questionnaire from the survey Zero to Eight: Children's Media Use in America (Common Sense Media, 2013) will be used. This instrument includes questions regarding the types of media used by both children and caregivers, as well as the duration and frequency of use. The research team at Common Sense Media approved the translation of the questionnaire. For the present study, additional adaptations will be made to better capture the use of specific screens in families with infants aged 0 to 12 months.	At 6 months of age.
Change from Baseline in Infant screen exposure	A Portuguese-adapted version of the questionnaire from the survey Zero to Eight: Children's Media Use in America (Common Sense Media, 2013) will be used. This instrument includes questions regarding the types of media used by both children and caregivers, as well as the duration and frequency of use. The research team at Common Sense Media approved the translation of the questionnaire. For the present study, additional adaptations will be made to better capture the use of specific screens in families with infants aged 0 to 12 months.	At 12 months of age.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infant development - Hammersmith Neonatal Neurological Examination	The Hammersmith Neonatal Neurological Examination (HNNE: Correr & Pfeifer, 2023), validated for Brazilian infants, is an objective measure, will be administered at the 1-2 months of infant life in its extended forms. The HNEE extended version consists of 34 items across six domains: (1) posture and tone, (2) tone patterns, (3) reflexes, (4) movements, (5) abnormal signs, and (6) orientation and behavior. The examination takes about 15 minutes, and each item is scored as 0.0 (abnormal), 0.5 (intermediate), or 1.0 (normal). The total score is the sum of individual items, with normality ranging from 30.5 to 34 points. A borderline score does not necessarily indicate neurological issues but suggests the need for regular follow-up. It will be conducted by a trained professional with more than 10 years of experience in infant assessment. This measure will be used as a baseline to control for subsequent outcome measures.	At 1 to 1.5 months of age.
Maternal dietary quality - SISVAN	Maternal dietary quality will also be assessed using the Food Intake Markers Questionnaire from the Food and Nutrition Surveillance System (FIMQ-SISVAN). This instrument is integrated into Brazil's public health system, and it is recognized for being practical and effective (Brazil, 2015; Louzada et al., 2023). The questionnaire will be administered at all five evaluation time points.	At 1 to 1.5 months of age.
Change from Baseline in Maternal dietary quality - SISVAN	Maternal dietary quality will also be assessed using the Food Intake Markers Questionnaire from the Food and Nutrition Surveillance System (FIMQ-SISVAN). This instrument is integrated into Brazil's public health system, and it is recognized for being practical and effective (Brazil, 2015; Louzada et al., 2023). The questionnaire will be administered at all five evaluation time points.	At 4 months of age.
Change from Baseline in Maternal dietary quality - SISVAN	Maternal dietary quality will also be assessed using the Food Intake Markers Questionnaire from the Food and Nutrition Surveillance System (FIMQ-SISVAN). This instrument is integrated into Brazil's public health system, and it is recognized for being practical and effective (Brazil, 2015; Louzada et al., 2023). The questionnaire will be administered at all five evaluation time points.	At 6 months of age.
Change from Baseline in Maternal dietary quality - SISVAN	Maternal dietary quality will also be assessed using the Food Intake Markers Questionnaire from the Food and Nutrition Surveillance System (FIMQ-SISVAN). This instrument is integrated into Brazil's public health system, and it is recognized for being practical and effective (Brazil, 2015; Louzada et al., 2023). The questionnaire will be administered at all five evaluation time points.	At 9 months of age.
Change from Baseline in Maternal dietary quality - SISVAN	Maternal dietary quality will also be assessed using the Food Intake Markers Questionnaire from the Food and Nutrition Surveillance System (FIMQ-SISVAN). This instrument is integrated into Brazil's public health system, and it is recognized for being practical and effective (Brazil, 2015; Louzada et al., 2023). The questionnaire will be administered at all five evaluation time points.	At 12 months of age.
Maternal eating behavior - Three Factor Eating Questionnaire - R21 (TFEQ-R21)	Maternal eating behavior will be assessed using the Three Factor Eating Questionnaire - R21 (TFEQ-R21) (Stunkard & Messick, 1985), validated for the Brazilian population (Natacci & Ferreira Júnior, 2011; Medeiros et al., 2017). The TFEQ-R21 is a self-report instrument consisting of 21 questions across three scales - Cognitive Restraint, Emotional Eating, and Uncontrolled Eating. Responses will be provided in a scored on a four-point Likert scale ("definitely false", "mostly false", "mostly true" and "definitely true") and an eight-point numerical rating scale. Scale scores will be calculated as the mean of the items within each domain, transformed into a scale from 0 to 100 to allow for direct comparison.	At 1 to 1.5 months of age.
Social Support - Medical Outcomes Study Social Support Survey (MOS-SSS)	This scale was developed from the Medical Outcomes Study Social Support Survey (MOS-SSS) (Sherbourne & Stewart, 1991) with the aim of assessing social support in a multidimensional manner. It consists of 19 self-report items rated on a 5-point Likert scale, designed to assess how often the participant perceives having support from others in various situations. The items are distributed across five dimensions: tangible support, affectionate support, emotional support, informational support, and positive social interaction. The authors reported Cronbach's alpha coefficients greater than 0.91 for all dimensions (Sherbourne & Stewart, 1991). In the Brazilian translation and validation, internal consistency was high, with Cronbach's alpha coefficients ranging from 0.76 to 0.95 (Griep et al., 2005; Zanini & Peixoto, 2018).	At 6 months of age.
Change from Baseline in Social Support - Medical Outcomes Study Social Support Survey (MOS-SSS)	This scale was developed from the Medical Outcomes Study Social Support Survey (MOS-SSS) (Sherbourne & Stewart, 1991) with the aim of assessing social support in a multidimensional manner. It consists of 19 self-report items rated on a 5-point Likert scale, designed to assess how often the participant perceives having support from others in various situations. The items are distributed across five dimensions: tangible support, affectionate support, emotional support, informational support, and positive social interaction. The authors reported Cronbach's alpha coefficients greater than 0.91 for all dimensions (Sherbourne & Stewart, 1991). In the Brazilian translation and validation, internal consistency was high, with Cronbach's alpha coefficients ranging from 0.76 to 0.95 (Griep et al., 2005; Zanini & Peixoto, 2018).	At 12 months of age.

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre
• Collaborators: Conselho Nacional de Desenvolvimento Científico e Tecnológico; UNIVERSIDADE FEDERAL DO RIO GRANDE DO SUL (UFRGS)
• Investigators: Principal Investigator: Clécio H Silva, PhD, Hospital De Clinicas De Porto Alegre

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2024
• Primary Completion (Estimated): December 20, 2027
• Study Completion (Estimated): August 30, 2028

Study Registration Dates

• First Submitted: February 23, 2026
• First Submitted That Met QC Criteria: February 23, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 23, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: postpartum depression; light therapy; child development; child growth
• Additional Relevant MeSH Terms: Urogenital Diseases; Mental Disorders; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Mood Disorders; Puerperal Disorders; Depressive Disorder; Depression, Postpartum
• Other Study ID Numbers: 2024-0089; CAAE 78853224.5.0000.5327 (Other Identifier: Comitê de Ética em Pesquisa do Hospital de Clínicas de Porto Alegre); 405657/2023-4 (Other Identifier: Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No