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Completed

NCT Number: NCT03379077

Learning Through Play (LTP) Plus Group Cognitive Behaviour Therapy for Mothers of Young Children (ROSHNI-2)

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).

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Key information

Conditions

Mothers

Age range

18 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Gadap

Karachi, Sindh, Pakistan

About this study

In Pakistan, the Learning through Play parenting program was tested initially through a cluster randomized study in a rural area of Pakistan. The results of this recently completed cluster RCT funded by the Grand Challenges Canada (GCC) showed that LTP Plus works and benefits both the mother and the child. More specifically, the results indicate a significant reduction in maternal depression.

Purpose of this cluster RCT is to determine if supported implementation of the LTP plus programme improves infant development compared to standard implementation of the LTP plus programme. This is an implementation trial comparing two ways of introducing LTP plus. A Cluster RCT of culturally adapted intervention LTP Plus will be conducted in the villages of Gadap town, Karachi, Pakistan. Total 60 villages will be randomized in two groups LTP plus and LTP plus supported implementation. Each cluster will be made of up to 15 mothers. Participants will be screened using eligibility checklist. Assessments will be done at baseline and after completion of intervention (3-month). All follow ups will be done by independent RAs, not involved in delivering intervention sessions.

Who can participate

Healthy volunteers accepted: Yes

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 0-33 months, resident in the trial site catchments area, who are able to complete assessments

Exclusion criteria

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.

Treatment and study plan

LTP Plus

Behavioral

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.

Other names: Psycho-social Intervention

Primary outcomes

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

    Time frame: Change from baseline at 3rd Month

    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.

Other outcomes

  1. Patient Health Questionnaire (PHQ)

    Time frame: Baseline and 3rd Month

    The Patient health Questionnaire (PHQ) is a simple 10 item self-report questionnaire will also be administered by a trained research worker. A score of 10 or more is taken as cut -off for depressive disorder, however all mothers meeting eligibility criteria will be included, despite their scores on PHQ-9.

  2. Generalized Anxiety Disorder (GAD) 7

    Time frame: Baseline and 3rd Month

    The GAD-7 is a 7 item scale will be used to screen for and measure severity of Generalized Anxiety Disorder

  3. Knowledge of Expectation and Child Development

    Time frame: Baseline and 3rd Month

    A 25-item questionnaire will be used to assess maternal knowledge and expectations for child development in the first three years

  4. Parenting Stress Index - Short Form

    Time frame: Baseline and 3rd Month

    Parents rate 36 items on a five-point scale (1-5) on three scales: (1) Parenting Distress, (2) Difficult Child Characteristics, and (3) Dysfunctional Parent-Child Interaction.

  5. Multidimensional Scale of Perceived Social Support (MSPSS)

    Time frame: Baseline and 3rd Month

    This brief scale will be used to measure social support

  6. Euro-Qol-5 Dimensions (EQ-5D)

    Time frame: Baseline and 3rd Month

    Health-related quality of life will be measured using the EQ-5D

  7. Client Service Receipt Inventory

    Time frame: Baseline and 3rd month

    We will collect information about the use of other health services (including the informal sector faith healers/Imams) using CSRI.

  8. CSQ Client Satisfaction Questionnaire

    Time frame: 3rd Month

    The participants will rate their satisfaction with treatment after completion of intervention using the CSQ.

Sponsors and collaborators

Lead sponsor

Pakistan Institute of Living and Learning

Other

Collaborators

  • Health and Nutrition Development Society
  • Hincks Dellcrest Centre

Registry information

Official study title

Implementing Learning Through Play (LTP) Plus Group Cognitive Behaviour Therapy (CBT) for Mothers of Young Children (0-3 Years) in Gadap Town (Roshni-2).

Acronym: ROSHNI-2

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 20, 2017
Registry last updated
Apr 29, 2022

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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