Early Intervention Therapy for Children With Delayed Development: Enabling Access in India's Rural Communities

A

Amar Seva Sangam

Status

Completed

Conditions

Developmental Delay

Treatments

Other: Rehabilitation therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT03202966

0819-05

Details and patient eligibility

About

This study is a cohort longitudinal design, also known as within subject repeated measures' design to measure the impact of an early identification and intervention program being implemented by Amar Seva Sangam (ASSA), an Indian non-government organization in South India. The primary objective of the Early Intervention (EI) Village-Based Rehabilitation (VBR) program is to increase access to early identification and early intervention therapy to enhance physical, cognitive, language, social and emotional development of children with developmental delays. The primary outcome will be the creation of developmental trajectory of girls and boys with developmental delay who are receiving village based early intervention therapy in rural India, aged 0 - 6 years based on the Gross Motor Function Measure - GMFM (children with cerebral palsy only), Functional Independence Measure - wee-FIM, Functional Assessment Checklist for Programming - FACP, Communication Developmental Eclectic Approach to Language Learning - CDDC and Canadian Occupational Performance Measure - COPM. Secondary outcomes will be the effect of therapy compliance rates on development in girls and boys with developmental delay, the effect of therapeutic approach on development in girls and boys with developmental delay, improved enrolment in school for children with developmental delays from age 3 to 6; and, improved parent/caregiver knowledge, attitude, behavior and confidence in caring for their child with developmental delay.

Full description

This study is a cohort longitudinal design, also known as within subject repeated measures' design to measure the impact of an early identification and intervention program being implemented by Amar Seva Sangam (ASSA), an Indian non-government organization in South India. The primary objective of the Early Intervention (EI) Village-Based Rehabilitation (VBR) program is to increase access to early identification and early intervention therapy to enhance physical, cognitive, language, social and emotional development of children with developmental delays. The primary outcome will be the creation of developmental trajectory of girls and boys with developmental delay who are receiving village based early intervention therapy in rural India, aged 0 - 6 years based on the Gross Motor Function Measure - GMFM (children with cerebral palsy only), Functional Independence Measure - wee-FIM, Functional Assessment Checklist for Programming - FACP, Communication Developmental Eclectic Approach to Language Learning - CDDC and Canadian Occupational Performance Measure - COPM. Secondary outcomes will be the effect of therapy compliance rates on development in girls and boys with developmental delay, the effect of therapeutic approach on development in girls and boys with developmental delay, improved enrolment in school for children with developmental delays from age 3 to 6; and, improved parent/caregiver knowledge, attitude, behavior and confidence in caring for their child with developmental delay.

For each child with a developmental delay who is enrolled in the early intervention program, a detailed care plan will be developed by the rehabilitation professional(s) who will provide the care based on the specific needs of the child. A trained community rehabilitation worker (CRW) will implement the care plan with a focus on the one or more domains where delays were identified (i.e. speech, motor, cognition). The intervention will be delivered either within the child's home (home based rehabilitation) or at an local Early Intervention Parent Participation Centre (EI PPCs) (centre based care). Each child will receive a minimum of one therapy session per week by the CRW and a monthly therapist visit (i.e., physical therapist, occupational therapist, special educator and/or speech therapist) for home based care. In center based care daily therapy will be available by either a CRW or specialist. In addition, monthly team meetings will be held by the specialists and CRWs to monitor progress and modify or adapt therapy plans as needed. Therapy will be tailored based on the needs of the individual child and will follow current evidence-based practice. The investigators will do evaluations using the standardized scales noted above (GMFM, WEE FIM, COPM, FACP and COM DEALL) every 6 months to monitor the progress of the child.

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

1,050 participants in 1 patient group

Intervention

Experimental group

Description:

For each child with a developmental delay enrolled in the early intervention program, individualized rehabilitation therapy will be provided by a rehabilitation professional with a focus on the one or more domains where delays were identified (i.e. speech, motor, cognition). The intervention will be delivered either as home based rehabilitation or as centre based care. Each child will receive a minimum of one therapy session per week by the CRW and a monthly therapist visit for home based care. In center based care daily therapy will be available by either a CRW or specialist.

Treatment:

Other: Rehabilitation therapy

Trial contacts and locations

2

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