Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Duke University | OTHER |
| Columbia University | OTHER |
| University of Liverpool | OTHER |
| University of Essex |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Background
The negative effects of perinatal depression on mother and child start early and persist throughout the life-course. Given that 10-35% of children worldwide are exposed to perinatal depression in their first year of life, 16 mitigating this intergenerational risk is a global public health priority. However, there is a dearth of studies on whether a maternal depression intervention can have long-term benefits for either the mother or her child. This is a study of the effectiveness of an extended 36-month peer-delivered depression intervention, the Thinking Healthy Programme PLUS (THPP+) for women and their children in rural Pakistan.
Study Design
The THPP+ study aims to evaluate the effects of an extended 36-month perinatal depression intervention on mother and child outcomes using a cluster randomized controlled trial (c-RCT) design. The trial will recruit 560 pregnant women who screened positive for perinatal depression (PHQ-9 >=10) from 40 village clusters, of which 20 clusters will receive the THPP+ intervention delivered by trained peers. These women will have already been participating in the trial of the shorter, 6 month long, version of the intervention. Women in the THPP+ intervention arm will receive bimonthly group-based sessions. Primary outcomes are 3-year maternal depression and 3-year child socio-emotional and cognitive development. All primary analyses will be intention-to-treat and will account for the clustered study design.
Discussion
This trial has the potential to further significantly our understanding of whether intervening on women's perinatal depression can mitigate the negative effects of maternal depression on 36-month child development.
Every year millions of children begin a compromised developmental trajectory resulting from exposure to maternal depression. In recent years, compelling evidence that maternal depression leads to worse developmental outcomes in the child has prompted a dramatic increase in efforts to ameliorate it. However, empirical evidence linking depression treatment to improved developmental trajectories in offspring is far from robust. The evidence is lacking due to several methodological limitations of previous studies, namely, insufficient follow-up, lack of appropriate control group, and/or lack of attention to the psychological and behavioral mechanisms underlying the impact of interventions on both the mother and child.
We propose an innovative, cost-effective extension to an NIMH-funded perinatal depression cluster randomized controlled intervention trial (RCT) in Pakistan (SHARE: U19MH095687). The SHARE RCT includes individual and community-wide components and follows mothers with prenatal depression until 6 months postpartum. Our proposal, SHARE CHILD, builds on this trial in several critical ways. We (1) focus on child outcomes, (2) extend follow-up to 36 months postpartum, (3) include mothers who did not screen positive for depression in the 3rd trimester, thus enabling additional comparisons, and (4) investigate factors that mediate and modify the effect of the intervention on child outcomes. A unique window of opportunity is made possible due to the anticipated spring 2014 enrollment start date of the SHARE trial.
Our long-term goal is to identify key modifiable factors in the intergenerational transmission of risk from depressed mothers to their children. The overall objective of this proposal is to rigorously evaluate the impact of a community based perinatal depression intervention on child development by expanding the sample of an already funded RCT and extending the follow-up period to 36 months postpartum. Our central hypothesis is that the perinatal depression intervention will lead to improved child socio-emotional, cognitive, and physical outcomes. Including the non-depressed dyads in our analyses will enable us to further determine (a) how much of the excess risk due to maternal depression exposure the intervention can mitigate and (b) whether this community based intervention has an impact on all children living in the intervention clusters, even if their mothers were not depressed prenatally. Such insights would not otherwise be possible without this expanded sample given the dearth of information on child developmental norms in this setting. Together, the unique opportunity to extend the SHARE trial to the broader SHARE CHILD study and the approaches we propose will yield novel and definitive evidence of the impact of treating perinatal depression on child developmental outcomes.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| THPP+ | Experimental | As part of THPP+, the intervention will continue from the 6th month postnatal through 36 months postnatal and so will consist of an additional 30 months of lower intensity services that are unique to THPP+. The THPP+ will also include additional group sessions to be held every other month for a total of 18 over the intervention duration. The content will be a continuation of the previous THPP sessions with continuing emphasis on self-care as well as the baby's health and development. |
|
| Enhanced Usual Care | Active Comparator | Women in the control clusters who were depressed prenatally have been receiving Enhanced Usual Care (EUC). At the time of the screening, women, their Lady Health Workers, and their local primary health care facility were informed of the diagnosis, and women were given an information sheet about depression and how to access care. There are no new EUC protocols put in place post-partum as part of the THPP+. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thinking Healthy Program Peer Delivered Plus | Behavioral |
| ||
| Enhanced Usual Care |
| Measure | Description | Time Frame |
|---|---|---|
| Depression (PHQ-9 Instrument) | The PHQ-9 is a 9-question instrument given to patients in a primary care setting to screen for the presence and severity of depression. The results may be used to make a depression diagnosis according to the DSM-IV criteria. The PHQ-9 asks about patients experience in the last two 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). Scores range from 0-27, a total of 10 or above is suggestive of the presence of depression. PHQ-9 score Depression severity 0-4 minimal depression 5-9 mild depression 10-14 moderate depression 15-19 moderately severe depression 20+ severe depression | 36 months post-partum |
| Child Strength and Difficulties Questionnaire (SDQ) Total Difficulties (TD) Score | The SDQ is a parent-reported measure of 25 child attributes with five subscales of 5 items each; emotional symptoms, conduct problems, hyperactivity, peer problems, and prosocial behavior. The TD score is calculated on the basis of four subscales (omitting prosocial behavior) with a score range of 0-40 points. The SDQ is widely used in low and middle-income countries and has been translated into Urdu. High SDQ scores are associated with a substantial increase in psychiatric risk. The TD score of our child participants is listed as a mean in the values below. TD score of 0-13 is considered "close to average, clinically significant problems in this area are unlikely," 14-16 is "slightly raised, which may reflect clinically significant problems," and 17-40 is "high, there is substantial risk of clinically significant problems in this area." | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Disability (WHO Disability Assessment Schedule 2.0) | WHODAS 2.0 was used to assess disability in the women in the cohort, the 12-item questionnaire was used to assess level of functionality over the last 30 days. The cohort was asked questions 2-13, and simple scoring was used. Responses to questions were none (0 points), mild difficulty (1 point), severe difficulty (2 points), and extreme difficulty/cannot do (4 points). Responses to the items were summed and scaled to a 0-100 scale to compute a total score, where 0 indicated no disability and 100 indicated full disability. |
| Measure | Description | Time Frame |
|---|---|---|
| Infant Physical Development [Z-scores (Based on WHO Criteria)] | Child growth was analyzed with the weight-for-age and length-for-age z scores. | 36 months |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Siham Sikander | Human Development Research Foundation, Pakistan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Human Development Research Foundation | Islamabad | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33632175 | Derived | LeMasters K, Bates LM, Chung EO, Gallis JA, Hagaman A, Scherer E, Sikander S, Staley BS, Zalla LC, Zivich PN, Maselko J. Adverse childhood experiences and depression among women in rural Pakistan. BMC Public Health. 2021 Feb 25;21(1):400. doi: 10.1186/s12889-021-10409-4. | |
| 32828167 | Derived | Maselko J, Sikander S, Turner EL, Bates LM, Ahmad I, Atif N, Baranov V, Bhalotra S, Bibi A, Bibi T, Bilal S, Biroli P, Chung E, Gallis JA, Hagaman A, Jamil A, LeMasters K, O'Donnell K, Scherer E, Sharif M, Waqas A, Zaidi A, Zulfiqar S, Rahman A. Effectiveness of a peer-delivered, psychosocial intervention on maternal depression and child development at 3 years postnatal: a cluster randomised trial in Pakistan. Lancet Psychiatry. 2020 Sep;7(9):775-787. doi: 10.1016/S2215-0366(20)30258-3. |
Not provided
Not provided
1154 pregnant women were enrolled in the study. Enhanced usual care (EUC) group had 287, THPP had 283, no prenatal depression had 584. The study team attempted to interview all women at all follow up visits (baseline, 3 mo, 6 mo, 12 mo, 24 mo, 36 mo). If a woman missed a previous visit, (LTFU, temporarily absent, refused) she was not excluded from participating in further visits. Therefore, the number of participants at each follow up visit may increase and decrease but will not exceed 1154.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Enhanced Usual Care | Women in the control clusters who were depressed prenatally have been receiving Enhanced Usual Care (EUC). At the time of the screening, women, their Lady Health Workers, and their local primary health care facility were informed of the diagnosis, and women were given an information sheet about depression and how to access care. There are no new EUC protocols put in place post-partum as part of the THPP+. |
| FG001 | THPP+ | As part of THPP+, the intervention will continue from the 6th month postnatal through 36 months postnatal and so will consist of an additional 30 months of lower intensity services that are unique to THPP+. The THPP+ will also include additional group sessions to be held every other month for a total of 18 over the intervention duration. The content will be a continuation of the previous THPP sessions with continuing emphasis on self-care as well as the baby's health and development. Thinking Healthy Program Peer Delivered Plus |
| FG002 | No Prenatal Depression | No prenatal depression recorded at baseline. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Enrollment |
| |||||||||||||
| 3 Month Follow up |
| |||||||||||||
| 6 Month Follow up |
| |||||||||||||
| 12 Month Follow up |
| |||||||||||||
| 24 Month Follow up |
| |||||||||||||
| 36 Month Follow up |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Enhanced Usual Care | Informing participants and LHWs about depression status and ways to seek help. |
| BG001 | THPP and THPP+ | Group based booster sessions which included peer support behavioral activation and problem solving. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Depression (PHQ-9 Instrument) | The PHQ-9 is a 9-question instrument given to patients in a primary care setting to screen for the presence and severity of depression. The results may be used to make a depression diagnosis according to the DSM-IV criteria. The PHQ-9 asks about patients experience in the last two 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). Scores range from 0-27, a total of 10 or above is suggestive of the presence of depression. PHQ-9 score Depression severity 0-4 minimal depression 5-9 mild depression 10-14 moderate depression 15-19 moderately severe depression 20+ severe depression | Posted | Mean | Standard Deviation | score on a scale | 36 months post-partum |
|
Through study completion, an average of 3 years
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Enhanced Usual Care | Informing participants and LHWs about depression status and ways to seek help. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hernia | General disorders | Non-systematic Assessment |
The indicators of child socioemotional outcomes, although measured with validated and extensively used instruments, were mother reported, and, as such, susceptible to bias. However, if depression symptoms biased reporting, we would expect this to have affected the overall socioemotional domain, not just the hyperactivity or conduct problems reported in our study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Siham Sikander | Human Development Research Foundation | +923330590373 | sihamsikander@gmail.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 15, 2016 | Jan 14, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 14, 2019 | Nov 30, 2020 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
Not provided
Not provided
| OTHER |
Not provided
Not provided
Not provided
Not provided
| Other |
|
| 36 months post-partum |
| Infant Cognitive Development (Bayley Scales of Infant Development) | Bayley Scales of Infant Development-III (BSITD) is an individually administered assessment of the child's achievement of developmental milestones across five areas. For this study, we focus on receptive language and fine motor domains at 36 months. A higher score means higher functioning. The two subscales are not combined, but treated as separate variables. The subscales are scaled according to the procedure outlined in the Bayley reference manual, the scaled score minimum and maximums at 36 months are: Receptive- min: 5; max: 19, Fine Motor- min: 2; max: 19. | 36 months |
| Number of Participants With Depression (SCID Major Depressive Episode) | SCID is a semi-structured interview for the diagnoses of psychiatric disorders. It has been cross-culturally adapted for assessing depression among women during pregnancy and in the postpartum period. The PHQ-9 inquires about frequency of depressive symptoms in the last 2 weeks. Given that the PHQ-9 is a screening tool, we use the SCID module for current major depressive episode as a diagnostic tool to assess the criterion-related validity of using the scores from the PHQ-9 to measure the number of symptoms endorsed by the woman over time. The diagnostic and statistical manual of mental disorders (DSM) IV diagnosis of current major depressive episode is generated through the SCID algorithm. If a woman was diagnosed with at least 1 MDE she was included in the outcome below. | 36 months post-partum |
| 31941468 | Derived | LeMasters K, Andrabi N, Zalla L, Hagaman A, Chung EO, Gallis JA, Turner EL, Bhalotra S, Sikander S, Maselko J. Maternal depression in rural Pakistan: the protective associations with cultural postpartum practices. BMC Public Health. 2020 Jan 15;20(1):68. doi: 10.1186/s12889-020-8176-0. |
| 30819173 | Derived | Scherer E, Hagaman A, Chung E, Rahman A, O'Donnell K, Maselko J. The relationship between responsive caregiving and child outcomes: evidence from direct observations of mother-child dyads in Pakistan. BMC Public Health. 2019 Feb 28;19(1):252. doi: 10.1186/s12889-019-6571-1. |
| 27608926 | Derived | Turner EL, Sikander S, Bangash O, Zaidi A, Bates L, Gallis J, Ganga N, O'Donnell K, Rahman A, Maselko J. The effectiveness of the peer delivered Thinking Healthy Plus (THPP+) Programme for maternal depression and child socio-emotional development in Pakistan: study protocol for a three-year cluster randomized controlled trial. Trials. 2016 Sep 8;17(1):442. doi: 10.1186/s13063-016-1530-y. |
| NOT COMPLETED |
|
|
| NOT COMPLETED |
|
|
| NOT COMPLETED |
|
|
| NOT COMPLETED |
|
|
| NOT COMPLETED |
|
| BG002 | No Prenatal Depression | No prenatal depression at baseline. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Mother's education | Count of Participants | Participants |
|
| Nuclear family | Nuclear family describes the household composition. Nuclear family is a two parent household. | Count of Participants | Participants |
|
| Total number of children in the household | Count of Participants | Participants |
|
| Duration of depression (chronicity) | This group did not have prenatal depression at baseline. | Count of Participants | Participants |
|
| SES (assets) | Count of Participants | Participants |
|
Informing participants and LHWs about depression status and ways to seek help.
| OG001 | THPP and THPP+ | Group based booster sessions which included peer support behavioral activation and problem solving. |
| OG002 | No Prenatal Depression | No prenatal depression at baseline. |
|
|
|
| Primary | Child Strength and Difficulties Questionnaire (SDQ) Total Difficulties (TD) Score | The SDQ is a parent-reported measure of 25 child attributes with five subscales of 5 items each; emotional symptoms, conduct problems, hyperactivity, peer problems, and prosocial behavior. The TD score is calculated on the basis of four subscales (omitting prosocial behavior) with a score range of 0-40 points. The SDQ is widely used in low and middle-income countries and has been translated into Urdu. High SDQ scores are associated with a substantial increase in psychiatric risk. The TD score of our child participants is listed as a mean in the values below. TD score of 0-13 is considered "close to average, clinically significant problems in this area are unlikely," 14-16 is "slightly raised, which may reflect clinically significant problems," and 17-40 is "high, there is substantial risk of clinically significant problems in this area." | Posted | Mean | Standard Deviation | score on a scale | 36 months |
|
|
|
|
| Secondary | Disability (WHO Disability Assessment Schedule 2.0) | WHODAS 2.0 was used to assess disability in the women in the cohort, the 12-item questionnaire was used to assess level of functionality over the last 30 days. The cohort was asked questions 2-13, and simple scoring was used. Responses to questions were none (0 points), mild difficulty (1 point), severe difficulty (2 points), and extreme difficulty/cannot do (4 points). Responses to the items were summed and scaled to a 0-100 scale to compute a total score, where 0 indicated no disability and 100 indicated full disability. | Posted | Mean | Standard Deviation | score on a scale | 36 months post-partum |
|
|
|
|
| Secondary | Infant Cognitive Development (Bayley Scales of Infant Development) | Bayley Scales of Infant Development-III (BSITD) is an individually administered assessment of the child's achievement of developmental milestones across five areas. For this study, we focus on receptive language and fine motor domains at 36 months. A higher score means higher functioning. The two subscales are not combined, but treated as separate variables. The subscales are scaled according to the procedure outlined in the Bayley reference manual, the scaled score minimum and maximums at 36 months are: Receptive- min: 5; max: 19, Fine Motor- min: 2; max: 19. | Posted | Mean | Standard Deviation | score on a scale | 36 months |
|
|
|
|
| Secondary | Number of Participants With Depression (SCID Major Depressive Episode) | SCID is a semi-structured interview for the diagnoses of psychiatric disorders. It has been cross-culturally adapted for assessing depression among women during pregnancy and in the postpartum period. The PHQ-9 inquires about frequency of depressive symptoms in the last 2 weeks. Given that the PHQ-9 is a screening tool, we use the SCID module for current major depressive episode as a diagnostic tool to assess the criterion-related validity of using the scores from the PHQ-9 to measure the number of symptoms endorsed by the woman over time. The diagnostic and statistical manual of mental disorders (DSM) IV diagnosis of current major depressive episode is generated through the SCID algorithm. If a woman was diagnosed with at least 1 MDE she was included in the outcome below. | Posted | Count of Participants | Participants | 36 months post-partum |
|
|
|
|
| Other Pre-specified | Infant Physical Development [Z-scores (Based on WHO Criteria)] | Child growth was analyzed with the weight-for-age and length-for-age z scores. | Posted | Mean | Standard Deviation | z score | 36 months |
|
|
|
|
| 30 |
| 287 |
| 0 |
| 287 |
| 3 |
| 287 |
| EG001 | THPP and THPP+ | Group based booster sessions which included peer support behavioral activation and problem solving. | 28 | 283 | 0 | 283 | 5 | 283 |
| EG002 | No Prenatal Depression | No prenatal depression at baseline. | 47 | 584 | 0 | 584 | 7 | 584 |
| Child illness | General disorders | Non-systematic Assessment |
|
| Mother illness | General disorders | Non-systematic Assessment |
|
| Child disability | General disorders | Non-systematic Assessment |
|
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Primary (1-5) |
|
| Middle or secondary (6-12) |
|
| Tertiary >13 |
|
| 1-3 |
|
| 4 or more |
|
| Data missing |
|
| Lower-middle quintile |
|
| Middle quintile |
|
| Upper-middle quintile |
|
| Upper quintile |
|
|
| Mean Difference (Final Values) |
| 0.03 |
| 2-Sided |
| 95 |
| -0.83 |
| 0.90 |
| Superiority |
|
| Risk Ratio (RR) |
| -0.12 |
| 2-Sided |
| 95 |
| -0.33 |
| 0.10 |
| Superiority |