ISRCTN ISRCTN18350705
DOI https://doi.org/10.1186/ISRCTN18350705
Sponsor Indira Gandhi National Open University
Funder Investigator initiated and funded
Submission date
23/09/2026
Registration date
28/09/2026
Last edited
28/09/2026
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms Zakira Asharef
Principal investigator, Scientific, Public

LF2/320
Block No.5
Vrindavan Gardens
Pattom
Thiruvananthapuram
695004
India

ORCiD logoORCID ID 0009-0009-0201-5322
Phone +91 7356514314
Email zakira.mchpmpl2024@learner.manipal.edu

Study information

Primary study designObservational
Observational study designCross sectional study
Scientific titleGuiding Lights: Empowering Down syndrome families
Study acronymGuiding Lights
Study objectives The study explores the health, nutrition, and development profile of children with Down Syndrome in Yemen. Families are asked to provide information through surveys and questionnaires to help develop better educational materials and support guidelines.
Ethics approval(s)

Approved 01/07/2024, Student Service Centre (SSC) at the Indira Gandhi National Open University (IGNOU) (Maidan Garhi, New Delhi, 110068, India; +91 011-29571528; ssc@ignou.ac.in), ref: 2353490617

Health condition(s) or problem(s) studiedDown Syndrome (DS)
MethodologyThis is a cross-sectional study conducted in Happy Child Special Needs School “Down Syndrome" Rehabilitation Project, Seiyun, Hadramout,Yemen, with 53 children with Down Syndrome and their parents, where information was collected using translated ABCD and child basic information questionnaires and analyzed using descriptive statistics.
Intervention typeOther
Primary outcome measure(s)
  1. Health, Nutrition and Development measured using surveys and questionnaires (ABCD and child basic information forms) at the time of data collection
Key secondary outcome measure(s)
Completion date31/12/2024

Eligibility

Participant type(s)
Age groupMixed
Lower age limit2 Years
Upper age limit18 Years
SexAll
Target sample size at registration53
Total final enrolment53
Key inclusion criteria1. Children and teens with Down Syndrome
2. Aged 2 to 18 years
3. Both genders
Key exclusion criteriaNot meeting the key inclusion criteria
Date of first enrolment02/11/2024
Date of final enrolment31/12/2024

Locations

Countries of recruitment

  • Yemen

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to shareNo

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol file 28/09/2026 No No

Additional files

50339_Protocol.pdf
Protocol file

Editorial Notes

28/09/2026: Study’s existence confirmed by the Student Service Centre (SSC) at the Indira Gandhi National Open University (IGNOU), India.