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Completed

NCT Number: NCT03430622

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

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

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Key information

Conditions

Maternal Depression

Age range

18 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Pediatric units, Quetta, Balochistan, Pakistan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LTP Plus

Behavioral

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

TAU

Other

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

Other names: Treatment as Usual

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

  2. 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'.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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

  12. 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.

Sponsors and collaborators

Lead sponsor

Pakistan Institute of Living and Learning

Other

Registry information

Official study 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

Acronym: TLMC

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 13, 2018
Registry last updated
Jul 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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