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

NCT03430622 | Completed DMC

• 1 other identifier: PILL-Telemothercare01
• Study Type: interventional
• Target: 370
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Maternal Depression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Generalized Anxiety Disorder (GAD) 7

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

• The Postpartum Bonding Questionnaire (PBQ)

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

• Experiences in Close Relationships-Revised (ECR-R)

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

• Dyadic Adjustment Scale, (DAS)

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

• Client Service Receipt Inventory

  [Time Frame: Changes from baseline to 3rd month]

Study Arms (2)

LTP Plus

EXPERIMENTAL

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

Treatment as Usual (TAU)

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: Psycho-social Intervention

LTP Plus

TAU OTHER

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

Also known as: Treatment as Usual

Treatment as Usual (TAU)

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Participants will be included in the study if they are:
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pakistan Institute of Living and Learning: lead

Study Sites (6)

Pediatric units

Quetta, Balochistan, Pakistan

Location

Pedratric units

Lahore, Punjab Province, Pakistan

Location

Pediatric units

Hyderābād, Sindh, Pakistan

Location

Pediatric units

Karachi, Sindh, Pakistan

Location

Pediatric units

Nawabshah, Sindh, Pakistan

Location

Pediatric units

Peshawar, Sindh, Pakistan

Location

MeSH Terms

Interventions

Long-Term Potentiation; Therapeutics

Intervention Hierarchy (Ancestors)

Neuronal Plasticity; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Nasim Chaudhry

  Pakistan Institute of Living & Learning

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Researchers doing outcome assessment will be kept blind to the group allocations
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2018
• First Posted: February 13, 2018
• Study Start: February 20, 2018
• Primary Completion: August 20, 2019
• Study Completion: August 30, 2019
• Last Updated: July 13, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (6)