Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Thinking Healthy Program - Peer Delivered in Pakistan - Child-Focused
Brief Summary: 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.


Options:
A: Arm Label: THPP+; Type: EXPERIMENTAL; Interventions: Behavioral: Thinking Healthy Program Peer Delivered Plus | Arm Label: Enhanced Usual Care; Type: ACTIVE_COMPARATOR; Interventions: Other: Enhanced Usual Care | Intervention Type: BEHAVIORAL; Name: Thinking Healthy Program Peer Delivered Plus; Assigned to Arm(s): THPP+ | Intervention Type: OTHER; Name: Enhanced Usual Care; Assigned to Arm(s): Enhanced Usual Care
B: Arm Label: Self Help Plus; Type: EXPERIMENTAL; Interventions: Behavioral: Self Help Plus | Arm Label: Enhanced Treatment As Usual; Type: OTHER; Interventions: Other: Enhanced Treatment As Usual | Intervention Type: BEHAVIORAL; Name: Self Help Plus; Assigned to Arm(s): Self Help Plus | Intervention Type: OTHER; Name: Enhanced Treatment As Usual; Assigned to Arm(s): Enhanced Treatment As Usual
C: Arm Label: Intervention Program of Care; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Patient Education and Behavioral Activation, Behavioral: Supporting Self-Care (care coordinators), Other: Psychiatrist and Diabetologist Reviews, Other: Decision-support Electronic Health Record System | Arm Label: Control Arm; Type: PLACEBO_COMPARATOR; Interventions: Other: Standard of Care | Intervention Type: BEHAVIORAL; Name: Patient Education and Behavioral Activation; Assigned to Arm(s): Intervention Program of Care | Intervention Type: BEHAVIORAL; Name: Supporting Self-Care (care coordinators); Assigned to Arm(s): Intervention Program of Care | Intervention Type: OTHER; Name: Psychiatrist and Diabetologist Reviews; Assigned to Arm(s): Intervention Program of Care | Intervention Type: OTHER; Name: Decision-support Electronic Health Record System; Assigned to Arm(s): Intervention Program of Care | Intervention Type: OTHER; Name: Standard of Care; Assigned to Arm(s): Control Arm
D: Arm Label: Philani Intervention Program; Type: EXPERIMENTAL; Interventions: Behavioral: Philani Intervention Program | Arm Label: Standard Care; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Philani Intervention Program; Assigned to Arm(s): Philani Intervention Program

Answer: A