Ignite Creation Date:
2024-05-06 @ 3:52 AM
Last Modification Date:
2024-10-26 @ 11:40 AM
Study NCT ID:
NCT02394899
Status:
COMPLETED
Last Update Posted:
2016-10-27
First Post:
2015-02-04
Brief Title:
Improving Parental Psychosocial Functioning and Early Developmental Outcomes in Children With Sickle Cell Disease
Sponsor:
The University of The West Indies
Organization:
The University of The West Indies
Study Overview
Official Title:
Integrating a Parenting Intervention With Routine Care to Improve Parental Psychosocial Functioning and Early Developmental Outcomes in Children With Sickle Cell Disease
Status:
COMPLETED
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
There are all significant risk factors for poor early cognitive development and as such neurocognitive deficits have been demonstrated in pre-school children with sickle cell disease SCD This project assesses the efficacy of using an evidence-based early stimulation program combined with components to help parents cope with stress delivered during six routine monthly clinic visits to parents of children with sickle cell disease It is hoped that this innovation will improve parental psychological outcomes as well as child developmental outcomes
Detailed Description:
Children with sickle cell disease SCD are at risk of various complications many of which arise suddenly and call on the problem solving skills of their parents They are also at risk of neurocognitive delays these may become evident during the pre-school years Previous research by this group has demonstrated improved developmental outcomes after parental interventions incorporating play techniques in high risk and healthy pre-school children The aim of the study is to determine usefulness in children with SCD of similar developmental interventions augmented by lessons in problem solving
The study is a randomized controlled trial Parents of all infants with Hb SS homozygous sickle cell disease or Sβ0 -thalassemia disease identified by newborn screening during the initial year of the study will be invited to participate They will be randomized to intervention or control Parental stress infants development and hemoglobin levels will be measured at recruitment and again after six months The intervention will occur during monthly Penadur intramuscular Benzathine Penicillin visits and will include supervised play with their children using an inexpensive toy and participation in solving a problem which may arise as they parent their child with SCD At the end of the study all control dyads will also be given the toys used in the intervention All parents will be given the results of their childrens developmental assessments and appropriate referrals made if deficits are identified
The study is minimal risk Every effort will be made to maintain patient confidentiality Respect for and the maximum protection of the best interests of the research subjects will be maintained
The study is a randomized controlled trial Parents of all infants with Hb SS homozygous sickle cell disease or Sβ0 -thalassemia disease identified by newborn screening during the initial year of the study will be invited to participate They will be randomized to intervention or control Parental stress infants development and hemoglobin levels will be measured at recruitment and again after six months The intervention will occur during monthly Penadur intramuscular Benzathine Penicillin visits and will include supervised play with their children using an inexpensive toy and participation in solving a problem which may arise as they parent their child with SCD At the end of the study all control dyads will also be given the toys used in the intervention All parents will be given the results of their childrens developmental assessments and appropriate referrals made if deficits are identified
The study is minimal risk Every effort will be made to maintain patient confidentiality Respect for and the maximum protection of the best interests of the research subjects will be maintained
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None