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

NCT02394899 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2016-10-27

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Grand Challenges Canada

    collaborator OTHER
  • The University of The West Indies

    lead OTHER

Principal Investigators

  • Jennifer Knight-Madden, MBBS, PhD · The University of The West Indies

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2016-09-30
Completion
2016-09-30

Countries

  • Jamaica

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02394899 on ClinicalTrials.gov