Home » Trials » SLCTR/2022/001


Family- centered, early intervention package for infants at high risk for Neuro- Developmental Disabilities to promote language development during early infancy; a randomized controlled trial

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SLCTR Registration Number

SLCTR/2022/001


Date of Registration

06 Jan 2022

The date of last modification

Jan 06, 2022



Application Summary


Scientific Title of Trial

Family- centered, early intervention package for infants at high risk for Neuro- Developmental Disabilities to promote language development during early infancy; a randomized controlled trial


Public Title of Trial

A randomized controlled trial for a family- centered, early intervention package for infants who are born with high risk for Neuro- Developmental Disabilities at two government maternity hospitals in Colombo district, to promote language development during early infancy


Disease or Health Condition(s) Studied

Communication and cognitive development


Scientific Acronym

None


Public Acronym

None


Brief title

Family centered early intervention for language development in early infancy


Universal Trial Number

UTN- U1111-1270- 4714


Any other number(s) assigned to the trial and issuing authority

P/39/4/2021 (ERC, Faculty of Medicine, University of Kelaniya)


Trial Details


What is the research question being addressed?

Does the new family centered early intervention package to promote early language and cognitive skills, result in better than standard care in infants who are at risk for neuro developmental disabilities?


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Single blinded : Outcome assessors


Control

Standard therapy/practice


Assignment

Parallel


Purpose

Supportive care


Study Phase

Not Applicable


Intervention(s) planned

Study setting- The study population will be selected from Neonatal Intensive Care units (NICUs) and postnatal wards at two government sector maternity hospitals in Colombo district: De Soysa Hospital for Women (DMH), Colombo 08 and Castle Street Hospital for Women (CSHW), Colombo 08.

Participating infants will be stratified into different categories of birth weight based on the WHO classification Very low birth weight <1500g Low birth weight > 1500g

Once participants are recruited, they will undergo blocked randomization into intervention and control arms, ensuring a balance in each stratification according to birth weight. Allocation sequence will be generated using WinPepi software using block randomization method with 1:1 allocation ratio using block sizes of 6. Allocation concealment will be ensured by using serially numbered sealed opaque envelops.

Allocation concealment mechanism- Allocation concealment will be ensured by using serially numbered sealed opaque envelops. Each envelop will consist of the name of the arm allocated for a particular child. In order to prevent any intended or unintended sabotage of the allocation sequence, the name and date of birth of the participant would need to be written on the envelope prior to opening. Opening of the envelope is to be done by the research assistant (RA) with another staff member being present, who makes sure that the seal of the envelope is unbroken with participant details written on it. Carbon paper inside the envelope will transfer the information onto the PAC inside. Corresponding envelopes would be opened only after the enrolled participants completed all baseline assessments and it is time to allocate the intervention. This method will minimize the “selection bias”. The intervention group will be offered the new intervention and standard care will be provided to the control group.

Intervention- New family centred early intervention package It will be a six-month comprehensive package with goal- oriented activities and recommendations which covers the following areas and skills of early cognition, language and communication and feeding development. 1. Cognitive Skills- Cognitive skills will include sensory-motor development, exploration and manipulation, object relatedness, concept formation and memory. 2. Language and Communication Skills -Communication skills will include preverbal behaviors, receptive and expressive vocabulary development. 3. Eating and drinking Skills (Feeding)- related to early communication. The participants of the intervention group will receive the intervention package with materials at the recruitment. In this package there are guidance on what parent can do/ follow at their home environment to promote early language and communication development from birth to 9 months.

The package includes: • Parent’s guide- It contains information, instructions, advice, and specific activities according to the age range with guidelines in Sinhala, English and Tamil languages as separate booklets. • Communication and feeding development information • Low-cost materials examples for activities • A CD with supportive video demonstrations- The package includes a CD with supportive video demonstrations for selected aims and activities according to the specific age categories. This also consists with narration in Sinhala, English and Tamil languages separately. Video demonstrations will guide parents to facilitate their practices at home. • Parental evaluation checklists- These observational checklists guide parents to assess the child’s skills.

The intervention package will be introduced to the participants of the intervention group by the research assistant (RA) in a calm setting in the postnatal ward using one to one approach. The session will be around 45 minutes with clear explanations, demonstrations, and guidance with adequate time for questions and clarifications. - Once a month follow up session will be conducted through asynchronous (store and forward) telehealth method where the families will upload 2-4 minutes videos of the specified activities and the RA will evaluate and provide the feedback. - After 3 months of intervention a hybrid 30-minute telehealth session (synchronous and asynchronous) will be provided with video evaluation and live real time connection with feedback. Videos will be password protected and kept in personal custody. In each session participants will be encouraged to maintain a logbook and a record of participants will be maintained by the provider. - After 6 months the post intervention evaluation- a live physical session for 30- 45 minutes will be conducted by the PI on appointment basis using Bayley III infant and toddler scales of development.

Standard care As per the national guidelines, the control group will receive the standard newborn care promoting breast feeding. Every child born in Sri Lanka is given a Child Health Development Record (CHDR) at birth. It is used to record growth and development. Before discharge a newborn CHDR will be filled and signed at the place of childbirth. This includes simple instructions on child development stimulations. All newborns discharged will be included in the community-based surveillance through the area PHM who will promote breast feeding and supporting with growth and development monitoring. After 6 months the post intervention evaluation- a live physical session for 30- 45 minutes will be conducted by the PI on appointment basis using Bayley III infant and toddler scale of development.

Implementation- The allocation sequence will be generated by the statistician. The enrollment and assigning participants according to the sequence of allocation and introducing intervention package to the intervention group will be done by the research assistant (RA).

Blinding This is a single blinded RCT. The outcome assessor will conduct the pre- intervention evaluation and post- intervention assessment who is blinded to the treatment that each individual is receiving. The “Performance bias” will be minimized within this single blinded process.


Inclusion criteria

  1. Male and female infants aged between birth to 8 weeks at the point of discharge from hospital
  2. Infants at high risk for neuro developmental disabilities such as hypoxic ischemic encephalopathy, prematurity, neonatal seizures, jaundice requiring double photo therapy or exchange transfusion, neonatal meningitis and sepsis, neonates requiring ventilation, hypotension requiring inotropes, intra cranial hemorrhages following neonatal complications and requiring NICU care more than one week
  3. Families who are willing to commit for a follow up period of six months.
  4. Infants who will be residing in the Colombo District during the follow up period.

Exclusion criteria

  1. Infants who have major dysmorphism according to the clinical evidence will be excluded from the study referring the diagnosis cards.
  2. Infants who are referred to tertiary maternity hospitals for advanced peri-natal care and will be returning to their respective districts.
  3. Mothers who may have less family support and/ or intellectual abilities to carry out the interventions: single mothers, mothers with intellectual disability.
  4. Infants whose mothers have physical/ mental illnesses which requires intensive medical attention during immediate peri-natal period eg: liver failure, heart failure, postpartum depression also will be excluded from the study.

The 3rd and 4th exclusion criteria will be determined by probing the social and medical history/ records of the mothers.



Primary outcome(s)

1.

The mean composite language and cognitive scores in the intervention and the standard care groups measured using Bayley III cognitive scores and language skills scores.

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Six months after commencement of the intervention

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Secondary outcome(s)

1.

Psychological health of the primary care giver as determined by the Depression, Anxiety and Stress Scale- 21 (DASS-21), validated for the Sri Lankan population. (According to the standardized interpretation of this scale recommended cut-off scores for conventional severity labels (normal, mild, moderate, severe, extremely severe) for each subscales of depression, anxiety and stress will be used for analysis)

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At baseline and six months after commencement of the intervention

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Target number/sample size

84 (42 in each arm)The sample of 42 into each arm will be stratified into different categories of birth weight based on WHO classification as described under randomization. From CSHW 24 infants for very low birth weight category and 24 of low birth weight


Countries of recruitment

Sri Lanka


Anticipated start date

2022-01-12


Anticipated end date

2022-08-31


Date of first enrollment


Date of study completion


Recruitment status

Pending


Funding source

None


Regulatory approvals

None



State of Ethics Review Approval


Status

Approved


Date of Approval

2021-09-14


Approval number

P/ 39/04/2021


Details of Ethics Review Committee

Name: ERC, Faculty of Medicine, University of Kelaniya
Institutional Address:Ethics review committee, Faculty of Medicine, University of Kelaniya, Thalagolla Road, Ragama.
Telephone:0112961267
Email: ercmed@kln.ac.lk

Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Yvonne Weerasinghe
Speech and Language Therapist
Speech Therapy Unit, Lady Ridgeway Hospital for Children, Dr. Danister De Silva Road, Colombo 8
0112- 693711
0777663022

yskw1982@gmail.com

Contact Person for Public Queries

Prof. Samanmali P. Sumanasena
Professor in Paediatric disabilities Hon. consultant Paediatrician
Department of Disability Studies, Faculty of Medicine, Ragama.
0112958251
0777- 256768

samanmalis@yahoo.com


Primary study sponsor/organization

Yvonne Weerasinghe
Speech and Language Therapist
Speech Therapy Unit, Lady Ridgeway Hospital for Children, Dr. Danister De Silva Road, Colombo 8
0112- 693711, 0777663022

yskw1982@gmail.com

Secondary study sponsor (If any)







Trial Completion details


Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?

No


IPD sharing plan description

N/A


Study protocol available

No


Protocol version and date

Not Available


Protocol URL

Not Available


Results summary available

No


Date of posting results


Date of study completion


Final sample size


Date of first publication


Link to results


Brief summary of results