Please select the eligibility criteria that correspond 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: Inclusion Criteria:

* currently enrolled in THPP trial
* married
* residing in study area for the long term

Exclusion Criteria:

* Requiring immediate medical attention
* development of psychotic or manic episode
* broken mother-child dyad
B: Inclusion Criteria:

1. Age 18 or above;
2. Able to speak and understand the target languages: Arabic, and/or Urdu, and/or Dari, and/or English;
3. Asylum seeker or refugee;
4. Presence of psychological distress, as shown by a score of 3 or more at the 12 item General Health Questionnaire (GHQ-12 ≥ 3);
5. Both oral and written informed consent to enter the study.

Exclusion Criteria:

1. Presence of any mental disorders according to DSM-V and ICD-10, as shown by a positive M.I.N.I.;
2. Acute medical conditions contraindicating study participation, based on clinical judgment of the health care professional with a clinical background who performs the screening;
3. Clinical evidence of imminent suicide risk or suicide risk scored as "moderate or high" (or a positive suicidality behaviour disorder) by the M.I.N.I. (section SUICIDALITY);
4. Clinical evidence that the decision-making capacity is impaired.
C: Inclusion Criteria:

* Age ≥35 years
* Confirmed diagnosis of diabetes (documented glucose tolerance test or 2 venous glucose levels)
* PHQ-9 score≥10
* ≥1 poorly-controlled CVD risk factor (either HbA1c≥8.0% or SBP≥140 mmHg or LDL≥130 mg/dl), irrespective of medications used
* Willingness to consent to randomization.

Exclusion Criteria:

* The patient reports a "3" on the PHQ-9 questionnaire suicide item (Item No:9) which reflects very high suicide risk or the patient's PHQ-9 score is above 23 indicating severe depression requiring immediate referral
* Any participant reporting a "2" on the PHQ-9 suicide item (Item No:9) will be reviewed carefully and if considered too high risk, the participant will be excluded from enrollment in the trial and referred for more intensive psychiatric care.
* Already in psychiatrist's care or using antipsychotic or mood stabilizer medication or diagnosed dementia or bipolar disorder or schizophrenia (based on bipolar and schizophrenia modules of the MINI)
* Diabetes secondary to uncommon causes (e.g., chronic pancreatitis)
* Pregnancy or breastfeeding
* Documented CVD event (MI, stroke) in past 12 months
* End-stage renal disease awaiting transplant
* Malignancy or life-threatening disease with death probable in 3 years
* Alcohol or drug abuse
* No fixed address or contact details.
D: Inclusion Criteria:

* Pregnant woman and their children
* Age 18 or older
* Informed consent

Exclusion Criteria:

* Psychosis, neurological damage, inability to communicate with interviewer
* Inability to give consent

Answer: A