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

October 26, 2016 updated by: The University of The West Indies

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Jamaica
      • Kingston 7, Jamaica
        • Sickle Cell Unit, University of West Indies, Mona Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
The control dyad will receive usual care.
Experimental: Intervened
Parents receive training in problem solving skills and play therapy with their infants.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infant's development quotient (Griffiths Developmental Scale)
Time Frame: 6 months
Griffiths Developmental Scale
6 months
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
6 months
Parental problem solving skills (Social Problem Solving Inventory)
Time Frame: 6 months
Using Social Problem Solving Inventory: Questionnaires
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of The West Indies

Collaborators

Grand Challenges Canada

Investigators

  • Principal Investigator: Jennifer Knight-Madden, MBBS, PhD, The University of the West Indies

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

February 4, 2015

First Submitted That Met QC Criteria

March 19, 2015

First Posted (Estimate)

March 20, 2015

Study Record Updates

Last Update Posted (Estimate)

October 27, 2016

Last Update Submitted That Met QC Criteria

October 26, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0001 (Cancer Research Institute)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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