Developmental DelayNCT03202966
Early Intervention Therapy for Children With Delayed Development: Enabling Access in India's Rural Communities
A study testing Rehabilitation therapy in people with Developmental Delay, run by Amar Seva Sangam at 2 sites in India.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 6 years
- Conditions the study is for
- Developmental Delay
- What is being tested?
- Rehabilitation therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,050 participants
- Where
- 2 sitesIndia
- Study dates
- 1 Jul 2017to 30 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
India2 sites
Study site
Ayikudy, Tamil Nadu, 627852
Amar Seva Sangam
Ayikudy, 627852
About this study
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.
Read the 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.
- Conditions
- Developmental Delay
- Being tested
- Rehabilitation therapy
- Medical subject headings
- Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation therapyOther
Rehabilitation therapy will be provided by a trained community rehabilitation worker (CRW) and specialist (i.e., physical therapist, occupational therapist, special educator and/or speech therapist) with a focus on the one or more domains where delays are identified (i.e. speech, motor, cognition). Therapy will be tailored based on the needs of the individual child and will follow current evidence-based practice.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Other: Rehabilitation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Developmental Score Trajectory as Assessed by the Canadian Occupational Performance Measure (COPM)
The Canadian Occupational Performance Measure (COPM) is a standardized client-centred outcome measure. Using a semi-structured interview format, the participant would asked to identify individual goals for occupational performance, related to self-care, productivity and leisure, that the participant has difficulty completing. Participants are asked to identify the 5 most important problems and for each problem/goal they are asked to rate both their performance and satisfaction on a scale of 1 to 10 (1= poor performance, low satisfaction; 10 = good performance, high satisfaction). Total scores are calculated by adding the performance or satisfaction scores for all problems and dividing by the number of problems. The average scores (1 to 10) for each scale of the COPM (performance and satisfaction) are used for analysis and comparison between assessments.
Measured: From date of recruitment up to 2 years
Developmental Score Trajectory as Assessed by the Gross Motor Function Measure (GMFM-88)
The Gross Motor Function Measure (GMFM-88) is a validated assessment designed specifically for participants with cerebral palsy to evaluate change and development of participant's gross motor function. This is an 88-item assessment with each item scored on a 4-point system (0=does not initiate; 1=initiates; 2=partially completes; 3=completes; and NT=not tested). The GMFM-88 is a validated functional outcome measure, with demonstrated reliability and responsiveness that can be used to evaluate meaningful change in gross motor function over time.
Measured: From date of recruitment up to 2 years
Developmental Score Trajectory as Assessed by the Functional Independence Measure for Children (wee-FIM)
The Functional Independence Measure for Children (wee-FIM) is a standardized and internationally validated assessment that evaluates participant's performance in self-care, sphincter control, transfers, location, communication and social cognition. The wee-FIM is an 18-item measure using a 7-level ordinal scale (1=total assist and 7=complete independence). It is organized into 2 subscales - motor and cognitive. It has been validated in a variety of settings, including in developing countries and has been demonstrated to have transcultural applicability. The wee-FIM has an acceptable responsiveness to demonstrate change over time.
Measured: From date of recruitment up to 2 years
Developmental Score Trajectory as Assessed by the Communication DEALL Development Checklist (CDDC)
The Communication DEALL (Developmental Eclectic Approach to Language Learning) Developmental Checklist (CDDC) will be used for speech assessment. The CDDC evaluates skills in eight developmental domains including: gross motor, fine motor, activities of daily living, receptive language, expressive language, cognitive skills, social skills and emotional skills. Only the domains for expressive language and receptive language will be used for the assessments. A 5-point scale is used to measure skill development (0= not acquired; 1 acquired but lost; 2 acquired but inconsistently present; 3= acquired and consistently present but only in specific situations; 4=acquired and consistently present across all situations). Within each domain questions are divided into 12 subgroups based on 6-month age groups (i.e., 0-6 months, 6-12 months etc.). This instrument has been validated in urban children, age 0-6 years, in India and has strong inter rater reliability.
Measured: From date of recruitment up to 2 years
Developmental Score Trajectory as Assessed by the Functional Assessment Checklist Programming (FACP)
The Functional Assessment Checklist for Programming (FACP) is a standardized measure that evaluates a participant's performance in 4 domains: occupational, academic, social, and personal skills. This instrument was developed and validated in India for use in special education. A checklist is used to evaluate the performance or achievement of the participant in each task. Performance is measured on a 5-point scale (0 to 5), where 0 means totally unable and 5 means totally able. The usual evaluation is comprised of 120 items, but the investigators will use an 88 item version. A total percentage score is generated for each participant's overall performance.
Measured: From date of recruitment up to 2 years
Secondary outcomes (3)
Treatment Compliance as Assessed by Therapy Sessions Achieved by Therapy Assessments Planned
The treatment compliance measure will be calculated as a proportion based on the number of therapy sessions achieved by each participant by the number of therapy sessions planned for that participant.
Measured: From date of recruitment up to 2 years
School Enrolment of Participants as Assessed by Enrolment Status
School enrolment will be measured as a proportion of the participants who are enrolled in school by school type (preschool, primary school, special needs school).
Measured: From date of recruitment up to 2 years
Parent/Caregiver Change as Assessed by the Tirunelveli Early Intervention Caregiver Assessment Tool
The Tirunelveli Early Intervention Caregiver Assessment Tool will be used with the primary caregivers of the participants (i.e. the person who is most involved in the day-to-day care of the child with developmental delay). This instrument will measure 1) family empowerment using the 12-item family sub scale of the Family Empowerment Scale (FES); 2) caregiver burden using the Modified Caregiver Strain Index (MCSI); and, 3) interactions with the participant based on a newly constructed 10-item questionnaire.
Measured: From date of recruitment up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2017
- Study start1 Jul 2017
- Primary completion30 Jul 2019
- Study completion30 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Developmental DelayStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,050 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amar Seva Sangam
- Sponsor type
- University, hospital or other
- Collaborators
- Grand Challenges Canada, University of Toronto
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03202966
- Sponsor's protocol ID
- 0819-05
- Status last verified
- Apr 2020
- First submitted
- 25 Jun 2017
- Last updated
- 28 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Intervention Therapy for Children With Delayed Development: Enabling Access in India's Rural Communities
- ClinicalTrials.gov ID
- NCT03202966
- Acronym / sponsor ID
- 0819-05
- Conditions
- Developmental Delay
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,050 participants (actual)
- Lead sponsor
- Amar Seva SangamUniversity, hospital or other
- Collaborators
- Grand Challenges Canada, University of Toronto
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 30 Jul 2019 (actual)
- First posted
- 29 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Rehabilitation therapyFor 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. |
Who may qualify
- Ages
- Up to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rehabilitation therapyRehabilitation therapy will be provided by a trained community rehabilitation worker (CRW) and specialist (i.e., physical therapist, occupational therapist, special educator and/or speech therapist) with a focus on the one or more domains where delays are identified (i.e. speech, motor, cognition). Therapy will be tailored based on the needs of the individual child and will follow current evidence-based practice. | Other | Intervention |
Primary outcome
Developmental Score Trajectory as Assessed by the Canadian Occupational Performance Measure (COPM)
Time frame: From date of recruitment up to 2 years
The Canadian Occupational Performance Measure (COPM) is a standardized client-centred outcome measure. Using a semi-structured interview format, the participant would asked to identify individual goals for occupational performance, related to self-care, productivity and leisure, that the participant has difficulty completing. Participants are asked to identify the 5 most important problems and for each problem/goal they are asked to rate both their performance and satisfaction on a scale of 1 to 10 (1= poor performance, low satisfaction; 10 = good performance, high satisfaction). Total scores are calculated by adding the performance or satisfaction scores for all problems and dividing by the number of problems. The average scores (1 to 10) for each scale of the COPM (performance and satisfaction) are used for analysis and comparison between assessments.
Developmental Score Trajectory as Assessed by the Gross Motor Function Measure (GMFM-88)
Time frame: From date of recruitment up to 2 years
The Gross Motor Function Measure (GMFM-88) is a validated assessment designed specifically for participants with cerebral palsy to evaluate change and development of participant's gross motor function. This is an 88-item assessment with each item scored on a 4-point system (0=does not initiate; 1=initiates; 2=partially completes; 3=completes; and NT=not tested). The GMFM-88 is a validated functional outcome measure, with demonstrated reliability and responsiveness that can be used to evaluate meaningful change in gross motor function over time.
Developmental Score Trajectory as Assessed by the Functional Independence Measure for Children (wee-FIM)
Time frame: From date of recruitment up to 2 years
The Functional Independence Measure for Children (wee-FIM) is a standardized and internationally validated assessment that evaluates participant's performance in self-care, sphincter control, transfers, location, communication and social cognition. The wee-FIM is an 18-item measure using a 7-level ordinal scale (1=total assist and 7=complete independence). It is organized into 2 subscales - motor and cognitive. It has been validated in a variety of settings, including in developing countries and has been demonstrated to have transcultural applicability. The wee-FIM has an acceptable responsiveness to demonstrate change over time.
Developmental Score Trajectory as Assessed by the Communication DEALL Development Checklist (CDDC)
Time frame: From date of recruitment up to 2 years
The Communication DEALL (Developmental Eclectic Approach to Language Learning) Developmental Checklist (CDDC) will be used for speech assessment. The CDDC evaluates skills in eight developmental domains including: gross motor, fine motor, activities of daily living, receptive language, expressive language, cognitive skills, social skills and emotional skills. Only the domains for expressive language and receptive language will be used for the assessments. A 5-point scale is used to measure skill development (0= not acquired; 1 acquired but lost; 2 acquired but inconsistently present; 3= acquired and consistently present but only in specific situations; 4=acquired and consistently present across all situations). Within each domain questions are divided into 12 subgroups based on 6-month age groups (i.e., 0-6 months, 6-12 months etc.). This instrument has been validated in urban children, age 0-6 years, in India and has strong inter rater reliability.
Developmental Score Trajectory as Assessed by the Functional Assessment Checklist Programming (FACP)
Time frame: From date of recruitment up to 2 years
The Functional Assessment Checklist for Programming (FACP) is a standardized measure that evaluates a participant's performance in 4 domains: occupational, academic, social, and personal skills. This instrument was developed and validated in India for use in special education. A checklist is used to evaluate the performance or achievement of the participant in each task. Performance is measured on a 5-point scale (0 to 5), where 0 means totally unable and 5 means totally able. The usual evaluation is comprised of 120 items, but the investigators will use an 88 item version. A total percentage score is generated for each participant's overall performance.
3 secondary outcomes
Treatment Compliance as Assessed by Therapy Sessions Achieved by Therapy Assessments Planned
Time frame: From date of recruitment up to 2 years
School Enrolment of Participants as Assessed by Enrolment Status
Time frame: From date of recruitment up to 2 years
Parent/Caregiver Change as Assessed by the Tirunelveli Early Intervention Caregiver Assessment Tool
Time frame: From date of recruitment up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation therapy in people with Developmental Delay, run by Amar Seva Sangam at 2 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Developmental Score Trajectory as Assessed by the Canadian Occupational Performance Measure (COPM) (time frame: From date of recruitment up to 2 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2020; AzTrials last refreshed its copy on 31 Oct 2026.