Clinical trial NCT02394899: Improving Parental Psychosocial Functioning and Early Developmental Outcomes in Children With Sickle Cell Disease
Official title: Integrating a Parenting Intervention With Routine Care to Improve Parental Psychosocial Functioning and Early Developmental Outcomes in Children With Sickle Cell Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sickle Cell Disease
Cognitive Ability, General
Psychological Stress
Parenting
Keywords: SCD
early childhood intervention
parental stress
neurocognition
Lead sponsor: The University of The West Indies
Sponsor class: OTHER
Collaborators: name: Grand Challenges Canada
First posted: 2015-03-20
Enrollment: 64
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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, 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.

Eligibility criteria: Inclusion Criteria:

* Infant has sickle cell disease: SS or Sβ0 thalassemia
* Attending Sickle Cell Unit, Jamaica for routine care

Exclusion Criteria:

* None

Primary outcomes:
measure: Infant's development quotient (Griffiths Developmental Scale)
timeFrame: 6 months
measure: Parental stress, depression and coping (Pediatric Inventory for Parents; CES-D; Coping Health Inventory for parents)
timeFrame: 6 months
measure: Parental problem solving skills (Social Problem Solving Inventory)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kingston 7
country: Jamaica
facility: Sickle Cell Unit, University of West Indies, Mona Campus
Study officials:
affiliation: The University of The West Indies
name: Jennifer Knight-Madden, MBBS, PhD
role: PRINCIPAL_INVESTIGATOR
References: