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

Study Overview
=================
Brief Summary
-----------------
To evaluate the effectiveness of a telephone based LTP Plus intervention for maternal depression.

Detailed Description
-----------------
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.

Official Title
-----------------
Telephone Delivered Learning Through Play (LTP) Plus Interpersonal Psychotherapy (IPT) for Depressed Mothers - A Multicentre Randomized Controlled Trial (RCT) in a Low-Income Country

Conditions
-----------------
Maternal Depression

Intervention / Treatment
-----------------
* Behavioral: LTP Plus
* Other: TAU


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 44 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LTP Plus<br>LTP Plus group participants will receive intervention over the telephone for 3 months one session per week for 2 months and rest of the sessions fortnightly by trained graduates, expert in delivering LTP plus intervention. | Behavioral: LTP Plus<br>* 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.<br>* Other names: Psycho-social Intervention;|
| Active Comparator: Treatment as Usual (TAU)<br>TAU group will receive routine care and their follow up will be done after completion of the intervention and then at 6-month post randomization. | Other: TAU<br>* This group will be on their routine care and will not be given any intervention<br>* Other names: Treatment as Usual;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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: Changes from baseline to 6th month after randomization ] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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: 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: 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: 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: 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. | [Time Frame: Changes from baseline to 3rd month] | 
| Infant development: Infant development: | Ages and Stages Questionnaire will be used to measure child development. Parents will report on their child's communication, gross and fine motor skills, problem solving and personal-social development at different time points. | [Time Frame: Changes from baseline to 3rd month and 6th month after randomization] | 
| Ages and Stages Social-Emotional Questionnaire | Ages and Stages will be used to obtain maternal report on their child's social and emotional development. The questionnaire is already translated in Urdu and will be used in the proposed trial. | Changes from baseline to 3rd month and 6th month after randomization] | 
| World Health Organisation Quality of Life (WHO, 2004) | A self-report scale comprising of 26 items which measures physical health, psychological health, social relationships and environment. | Changes from baseline to 3rd month and 6th month after randomization] | 
| Learning Through Play (LTP) KAP Questionnaire | This scale will be used to measure change in Knowledge, Attitude and Practices (KAP) at different time points. | Changes from baseline to 3rd month and 6th month after randomization] | 
| Patient Health Questionnaire (PHQ-9) | The Patient health Questionnaire (PHQ-9) is 9 items self-report questionnaire. A score of 10 or above is taken as cut -off point for depressive disorder. This scale will be used to check severity of depression. Patient Health Questionnaire (PHQ-9) The Patient health Questionnaire (PHQ-9) is 9 items self-report questionnaire. A score of 10 or above is taken as cut -off point for depressive disorder. This scale will be used to check severity of depression. | Time Frame: Changes from baseline to 3rd month and 6th month after randomization ] | 
| Client Satisfaction Questionnaire | The participants will rate their satisfaction with treatment after completion of intervention. Higher score indicate greater satisfaction | Time Frame: Score at 3rd month assessment only. | 
| How are you feeling scale | This is a pictorial scale to assess mood disturbance. higher score indicate greater severity of depression. | Time Frame: Changes from baseline to 3rd month and 6th month after randomization ] |