Learning Through Play (LTP) Plus Interpersonal Psychotherapy (IPT)

Pakistan Institute of Living and Learning370 enrolled

Overview

To evaluate the effectiveness of a telephone based LTP Plus intervention for maternal depression.

Despite the high prevalence of maternal depression in Pakistan, research on psychosocial interventions is limited. We will test the effectiveness of a telephone based intervention program called Learning through Play plus Interpersonal Psychotherapy (LTP Plus) that can be used by non-specialists, including trained graduates, mothers and lay health workers with minimal training. This telephone communication will be supplemented by the provision of LTP Plus pictorial calendars to the depressed mothers. Purpose of this RCT is to determine if telephone delivered intervention of the LTP plus programme reduces symptoms of maternal depression and improves infant development compared to Treatment as usual. A sample of 354 (177 in each group) will be required. The study will be conducted in big cities of Pakistan including Karachi, Lahore, Hyderabad, Nawabshah, Quetta and Peshawar.Participants will be screened using Patient Health Questionnaire (PHQ-9) and eligibility checklist. Those scoring 10 and above on PHQ-9 will be invited to participate in the study. Assessments will be done at baseline and after completion of intervention (3rd month and 6th month after randomization). All follow ups will be done by independent Research Assistants (RAs), blind to the treatment allocations.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

370

Conditions

Maternal Depression

Interventions

LTP PlusBEHAVIORAL

LTP Plus is comprised of two components; Learning through play (LTP) and Interpersonal Psychotherapy (IPT). The LTP Plus is a low-literacy; sustainable program intended to provide parents with information on the healthy growth and development of their young children. The LTP research-based activities enhance children's development while simultaneously promoting attachment security through building parents' ability to read and be sensitive to their children's cues and through active involvement in their children's development. Plus the Interpersonal Psychotherapy (IPT) intervention is comprised of a supportive element, an educational element, a parenting element and an interpersonal relationship element. Intervention goals include helping mothers feel supported, empowered and confident about their parenting abilities, which would directly influence reduction in depressive symptoms as well as resolution of interpersonal conflicts.

TAUOTHER

This group will be on their routine care and will not be given any intervention

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 44 Years

Medical Language ↔ Plain English

Inclusion Criteria: Participants will be included in the study if they are: 18 to 44 years old mothers with children aged between 0-30 months having a diagnosis of major depressive disorder using the Structure Clinical Interview for DSM-V, Ability to complete a baseline assessment, Participating mother having telephone/mobile phone access for at least one hour per week. Exclusion Criteria: Participants will be excluded from the study if they have: Any medical illness that will prevent them from participation in the clinical trial, current or past diagnosis of bipolar depression, currently using antidepressants or receiving any kind of psychotherapy, active suicidal ideation, any other severe physical or mental disorder, no access to telephone/mobile.

Locations (6)

Pediatric units

Quetta, Balochistan, Pakistan

Pedratric units

Lahore, Punjab Province, Pakistan

Pediatric units

Hyderābād, Sindh, Pakistan

Pediatric units

Karachi, Sindh, Pakistan

Outcomes

Primary Outcomes

Structured Clinical Interview for DSM-IV (SCID)

The primary outcome is depression which will be measured using Structured Clinical Interview for DSM-V Disorders (SCID)

Time frame: Time Frame: Changes from baseline to 6th month after randomization ]

Secondary Outcomes

Generalized Anxiety Disorder (GAD) 7

The GAD-7 is a 7 item scale will be used to screen for and measure severity of Generalized Anxiety Disorder

Time frame: [Time Frame: Changes from baseline to 3rd month and 6th month after randomization]

The Postpartum Bonding Questionnaire (PBQ)

The PBQ is designed to detect disturbance in the mother-child relationship. The scale has 25 items, each followed by six alternative responses ranging from 'always' to 'never'.

Time frame: [Time Frame: Changes from baseline to 3rd month and 6th month after randomization]

Experiences in Close Relationships-Revised (ECR-R)

The ECR-R measures individuals on two subscales of attachment: Avoidance and Anxiety. In general avoidant individuals find discomfort with intimacy and seek independence, whereas anxious individuals tend to fear rejection and abandonment.

Time frame: [Time Frame: Changes from baseline to 3rd month and 6th month after randomization]

Dyadic Adjustment Scale, (DAS)

DAS is a 32 items self-report questionnaire, to measure couple satisfaction and to assess how each partner perceives his/her relationship.

Time frame: [Time Frame: Changes from baseline to 3rd month and 6th month after randomization]

Client Service Receipt Inventory

We will collect information about the use of other health services (including the informal sector, faith healers/Imams) using CSRI based on our previous work in Pakistan.

Data from ClinicalTrials.gov

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