Mothers
Conditions
Keywords
Mothers, young children, Implementation, Learning through play Plus, Cognitive Behavior Therapy
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).
Detailed description
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.
Interventions
BEHAVIORALLTP Plus
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.
Sponsors
Health and Nutrition Development Society
Hincks Dellcrest Centre
Pakistan Institute of Living and Learning
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
researchers doing outcome assessment will be kept blind on both implementation groups
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 44 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infant development: Ages and Stages Questionnaire (Squires, Bricker, & Twombly, 2009) | 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
| Measure | Time frame | Description |
|---|---|---|
| Generalized Anxiety Disorder (GAD) 7 | 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 |
| Knowledge of Expectation and Child Development | 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 |
| Parenting Stress Index - Short Form | 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. |
| Patient Health Questionnaire (PHQ) | 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. |
| Euro-Qol-5 Dimensions (EQ-5D) | Baseline and 3rd Month | Health-related quality of life will be measured using the EQ-5D |
| Client Service Receipt Inventory | Baseline and 3rd month | We will collect information about the use of other health services (including the informal sector faith healers/Imams) using CSRI. |
| CSQ Client Satisfaction Questionnaire | 3rd Month | The participants will rate their satisfaction with treatment after completion of intervention using the CSQ. |
| Multidimensional Scale of Perceived Social Support (MSPSS) | Baseline and 3rd Month | This brief scale will be used to measure social support |
Countries
Pakistan
Outcome results
None listed