Skip to main content
OpenTrials
Completed

NCT Number: NCT02394899

Improving 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sickle Cell Disease Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Behavior Behavioral Symptoms Cognitive Ability, General Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies Parenting Psychological Stress Stress, Psychological

Age range

6 month–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sickle Cell Unit, University of West Indies, Mona Campus

Kingston, Jamaica

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

play therapy

Behavioral

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.

Problem solving skills

Other

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.

Primary outcomes

  1. Infant's development quotient (Griffiths Developmental Scale)

    Time frame: 6 months

    Griffiths Developmental Scale

  2. Parental stress, depression and coping (Pediatric Inventory for Parents; CES-D; Coping Health Inventory for parents)

    Time frame: 6 months

    Questionnaires to assess: Pediatric Inventory for Parents; CES-D; Coping Health Inventory for parents

  3. Parental problem solving skills (Social Problem Solving Inventory)

    Time frame: 6 months

    Using Social Problem Solving Inventory: Questionnaires

Sponsors and collaborators

Lead sponsor

The University of The West Indies

Other

Collaborators

  • Grand Challenges Canada

Registry information

Official study title

Integrating a Parenting Intervention With Routine Care to Improve Parental Psychosocial Functioning and Early Developmental Outcomes in Children With Sickle Cell Disease

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Mar 20, 2015
Registry last updated
Oct 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.