Clinical trial NCT03202966: Early Intervention Therapy for Children With Delayed Development: Enabling Access in India's Rural Communities
Official title: Early Intervention Therapy for Children With Delayed Development: Enabling Access in India's Rural Communities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Developmental Delay
Lead sponsor: Amar Seva Sangam
Sponsor class: OTHER
Collaborators: name: Grand Challenges Canada
name: University of Toronto
First posted: 2017-06-29
Enrollment: 1050
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Boys and girls
* Newborn to age 6
* Identified with developmental delay based on the Trivandrum screening tool
* Diagnosed as definitive delayed development by a team of rehabilitation specialists (i.e. physical therapist, occupational therapist, speech therapist, special educator)
* Receiving either home-based or center-based care in the ASSA Village-Based Early Intervention Program
* Live in one of the following 7 blocks in the District of Tirunelveli: Alangulam Block; Kadayanallur Block; Keelapavoor Block; Shenkottai Block; Tenkasi Block; Sankarankoil Block; and, Vasudevanallur Block

Exclusion Criteria:

* None

Primary outcomes:
measure: Developmental Score Trajectory as Assessed by the Canadian Occupational Performance Measure (COPM)
timeFrame: From date of recruitment up to 2 years
measure: Developmental Score Trajectory as Assessed by the Gross Motor Function Measure (GMFM-88)
timeFrame: From date of recruitment up to 2 years
measure: Developmental Score Trajectory as Assessed by the Functional Independence Measure for Children (wee-FIM)
timeFrame: From date of recruitment up to 2 years
measure: Developmental Score Trajectory as Assessed by the Communication DEALL Development Checklist (CDDC)
timeFrame: From date of recruitment up to 2 years
measure: Developmental Score Trajectory as Assessed by the Functional Assessment Checklist Programming (FACP)
timeFrame: From date of recruitment up to 2 years
Secondary outcomes:
measure: Treatment Compliance as Assessed by Therapy Sessions Achieved by Therapy Assessments Planned
timeFrame: From date of recruitment up to 2 years
measure: School Enrolment of Participants as Assessed by Enrolment Status
timeFrame: From date of recruitment up to 2 years
measure: Parent/Caregiver Change as Assessed by the Tirunelveli Early Intervention Caregiver Assessment Tool
timeFrame: From date of recruitment up to 2 years
Other outcomes:
Locations:
city: Ayikudy
country: India
state: Tamil Nadu
city: Ayikudy
country: India
facility: Amar Seva Sangam
Study officials:
References: