Sickle Cell Disease Clinical Trial
Official title:
Integrating a Parenting Intervention With Routine Care to Improve Parental Psychosocial Functioning and Early Developmental Outcomes in Children With Sickle Cell Disease
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.
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, infant's 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 children's 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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
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