NCT03379077

Brief Summary

The study has both quantitative and qualitative components. The objective of the quantitative study is to: Determine if supported implementation of the LTP plus programme improves infant development compared to standard implementation of the LTP plus programme. The objective of the qualitative study is: Process evaluation and finding out about implementation challenges (from the perspective of the mothers and the people delivering both the LTP plus and the supported implementation intervention).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,006

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 8, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 20, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

December 20, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
Last Updated

April 29, 2022

Status Verified

April 1, 2022

Enrollment Period

1.2 years

First QC Date

December 8, 2017

Last Update Submit

April 22, 2022

Conditions

Mothers

Keywords

Mothersyoung childrenImplementationLearning through play PlusCognitive Behavior Therapy

Outcome Measures

Primary Outcomes (1)

  • Infant development: Ages and Stages Questionnaire (Squires, Bricker, & Twombly, 2009)

    This scale will be used to measure child development. Parents will report on their child's communication,gross motor, fine motor, problem solving and personal-social development.

    Change from baseline at 3rd Month

Other Outcomes (8)

  • Patient Health Questionnaire (PHQ)

    Baseline and 3rd Month

  • Generalized Anxiety Disorder (GAD) 7

    Baseline and 3rd Month

  • Knowledge of Expectation and Child Development

    Baseline and 3rd Month

  • +5 more other outcomes

Study Arms (2)

LTP Plus Supported Implementation

EXPERIMENTAL

LTP Plus Supported Implementation group participants will receive intervention by trained LHWs of HANDS, co-facilitated and supervised by senior trained PILL researchers, expert in delivering LTP plus intervention

Behavioral: LTP Plus

LTP Plus

ACTIVE COMPARATOR

Participants in LTP Plus arm will receive LTP plus intervention by trained LHWs of Health and Nutrition Development Society (HANDS).

Behavioral: LTP Plus

Interventions

LTP PlusBEHAVIORAL

LTP Plus is comprised of two components; Learning through play (LTP) and Cognitive Behavior Therapy (CBT). 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 Thinking Healthy Program (THP) which adopts 'here and now' problem-solving approach. THP uses cognitive behavior therapy (CBT) techniques of active listening, changing negative thinking, and collaboration with the family.

Also known as: Psycho-social Intervention
LTP PlusLTP Plus Supported Implementation

Eligibility Criteria

Age18 Years - 44 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (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 0-33 months, resident in the trial site catchments area, who are able to complete assessments

You may not qualify if:

  • Participants will be excluded from the study if they have:
  • A medical disorder that would prevent participation in clinical trial. Temporary resident unlikely to be available for follow up. Active suicidal ideation or any other severe or physical mental disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gadap

Karachi, Sindh, Pakistan

Location

MeSH Terms

Interventions

Long-Term Potentiation

Intervention Hierarchy (Ancestors)

Neuronal PlasticityNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Nasim Chaudhry, (MRC Psych, FRC Psych, MD)

    Pakistan Institute of Living & Learning

    PRINCIPAL INVESTIGATOR

  • Nusrat Husain, (MD)

    University of Manchester

    PRINCIPAL INVESTIGATOR

  • Tayyeba Kiran, MS

    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 on both implementation groups
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2017

First Posted

December 20, 2017

Study Start

December 20, 2017

Primary Completion

February 28, 2019

Study Completion

February 28, 2019

Last Updated

April 29, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)