Improving Parental Psychosocial Functioning and Early Developmental Outcomes in Children With Sickle Cell Disease

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02394899
• Other study ID #: 0001
• Status: Completed
• Phase: N/A
• First received: February 4, 2015
• Last updated: October 26, 2016
• Start date: October 2014
• Est. completion date: September 2016

Study information

• Verified date: October 2016
• Source: The University of The West Indies
• Contact: n/a
• Is FDA regulated: No
• Health authority: Jamaica: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 12 Months

Eligibility

Inclusion Criteria:

• Infant has sickle cell disease: SS or Sß0 thalassemia

• Attending Sickle Cell Unit, Jamaica for routine care

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Cognitive Ability, General
• Parenting
• Psychological Stress
• Sickle Cell Disease
• Stress, Psychological

Intervention

Behavioral:
• Play therapy
Short films that have been developed to deliver a series of child development messages will be shown at the monthly visits. Nine modules of approximate length 3 minutes each have been developed and cover the topics: Love, Comforting baby, Talking to babies and children, Praise, Using bath time to play and learn, Looking at books, Simple toys mothers can make, Drawing and games, and Puzzles. Nurses at the Sickle cell Unit (SCU) will be trained to discuss the video messages with the mothers/caregivers, demonstrate activities they can do with their children and how to make simple toys from household materials. Mothers/caregivers will practice some of the activities and they will be encouraged to make them part of their daily routine.

Other:
• Problem solving skills
Problem solving therapy (PST) aims to empower patients or caregivers in attending to daily challenges. It is based on cognitive behavioural therapy and can be used in primary care settings. It encourages persons to use existing resources and skills to function better and find solutions to problems. It will be delivered in 6 sessions over the 6-week period and will last for about 30 minutes per session. The stages of PST are: identification of the problems; generating possible solutions; evaluating and implementing preferred solution; and evaluating to see if the solutions were successful. The parent/caregiver will be taught a process of problem solving with reference to general everyday problems as well as specific problems which may arise while parenting a child with SCD.

Locations

Country	Name	City	State
Jamaica	Sickle Cell Unit, University of West Indies, Mona Campus	Kingston 7

Sponsors (2)

Lead Sponsor	Collaborator
The University of The West Indies	Grand Challenges Canada

Country where clinical trial is conducted

Jamaica, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infant's development quotient (Griffiths Developmental Scale)	Griffiths Developmental Scale	6 months	No
Primary	Parental stress, depression and coping (Pediatric Inventory for Parents; CES-D; Coping Health Inventory for parents)	Questionnaires to assess: Pediatric Inventory for Parents; CES-D; Coping Health Inventory for parents	6 months	No
Primary	Parental problem solving skills (Social Problem Solving Inventory)	Using Social Problem Solving Inventory: Questionnaires	6 months	No