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

July 7, 2021 updated by: Pakistan Institute of Living and Learning

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
370

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Balochistan
      • Quetta, Balochistan, Pakistan
        • Pediatric units
    • Punjab
      • Lahore, Punjab, Pakistan
        • Pedratric units
    • Sindh
      • Hyderabad, Sindh, Pakistan
        • Pediatric units
      • Karachi, Sindh, Pakistan
        • Pediatric units
      • Nawabshah, Sindh, Pakistan
        • Pediatric units
      • Peshawar, Sindh, Pakistan
        • Pediatric units

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 44 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: LTP Plus
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
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.
Other Names:
  • Psycho-social Intervention
Active Comparator: Treatment as Usual (TAU)
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
This group will be on their routine care and will not be given any intervention
Other Names:
  • Treatment as Usual

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Structured Clinical Interview for DSM-IV (SCID)
Time Frame: Time Frame: Changes from baseline to 6th month after randomization ]
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Generalized Anxiety Disorder (GAD) 7
Time Frame: [Time Frame: Changes from baseline to 3rd month and 6th month after randomization]
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)
Time Frame: [Time Frame: Changes from baseline to 3rd month and 6th month after randomization]
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)
Time Frame: [Time Frame: Changes from baseline to 3rd month and 6th month after randomization]
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)
Time Frame: [Time Frame: Changes from baseline to 3rd month and 6th month after randomization]
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
Time Frame: [Time Frame: Changes from baseline to 3rd month]
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:
Time Frame: [Time Frame: Changes from baseline to 3rd month and 6th month after randomization]
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
Time Frame: Changes from baseline to 3rd month and 6th month after randomization]
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)
Time Frame: Changes from baseline to 3rd month and 6th month after randomization]
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
Time Frame: Changes from baseline to 3rd month and 6th month after randomization]
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)
Time Frame: Time Frame: Changes from baseline to 3rd month and 6th month after randomization ]

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
Time Frame: Time Frame: Score at 3rd month assessment only.
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
Time Frame: Time Frame: Changes from baseline to 3rd month and 6th month after randomization ]
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 ]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pakistan Institute of Living and Learning

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nasim Chaudhry, Pakistan Institute of Living & Learning

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 20, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 20, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 6, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 13, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 13, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PILL-Telemothercare01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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