Effectiveness of a Telephone Based Learning Through Play (LTP) Plus Interpersonal Psychotherapy (IPT) for Depressed Mothers (Telemothercare)
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|ClinicalTrials.gov Identifier: NCT03430622|
Recruitment Status : Recruiting
First Posted : February 13, 2018
Last Update Posted : April 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Postnatal Depression||Behavioral: LTP Plus Other: TAU||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||354 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Researchers doing outcome assessment will be kept blind to the group 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|
|Actual Study Start Date :||February 20, 2018|
|Estimated Primary Completion Date :||December 30, 2019|
|Estimated Study Completion Date :||December 30, 2019|
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 Name: 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.
This group will be on their routine care and will not be given any intervention
Other Name: Treatment as Usual
- 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.
- 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
- 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'.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03430622
|Contact: Nasim Chaudhry, (MRC Psych, FRC Psych, MD)||firstname.lastname@example.org|
|Contact: Rabia Sattar, MPhilemail@example.com|
|Pediatric units||Not yet recruiting|
|Quetta, Balochistan, Pakistan|
|Pedratric units||Not yet recruiting|
|Lahore, Punjab, Pakistan|
|Hyderabad, Sindh, Pakistan|
|Karachi, Sindh, Pakistan|
|Pediatric units||Not yet recruiting|
|Nawabshah, Sindh, Pakistan|
|Pediatric units||Not yet recruiting|
|Peshawar, Sindh, Pakistan|
|Principal Investigator:||Nasim Chaudhry||Pakistan Institute of Living & Learning|