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Clinical Trials/NCT05592834
NCT05592834CompletedNot Applicable

Effect of the Positive Deviance and Parent Facilitator Training Strategies to Malnutrition and Caregiving Among Children and Youth With CP in the Iganga, Mayuge and Bugweri Rural Districts of Eastern Uganda"

Makerere University1 site in 1 country124 target enrollmentStarted: August 1, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
124
Locations
1
Primary Endpoint
Nutritional status

Study Overview

Brief Summary

The goal of this factorial trial is to test and compare the effectiveness of two caregiver led strategies, i.e., the positive deviance nutrition(PD) strategy and the parent facilitator training (PFT) strategies, to malnutrition and care-giving among children and youth with cerebral palsy. Participants will be assigned to receive either of the four conditions, including,

  • PFT only,
  • PD only,
  • Both the PFT and PD,
  • None of the PD or PFT (controls) Researchers will compare either groups to see if there is an improvement in the nutritional status by weight gain and care giving knowledge and practices

Detailed Description

High malnutrition and related mortality risk is common among children with cerebral palsy (CP) in most low- and middle-income countries. This is partly due to limited access to mainstream health care services worsened by the scarcity of health professionals with an extra skill in special needs care, including the ability to manage feeding difficulties common in the CP population. Families of children with CP have thus been left alone to care for their child without a clear direction on how to provide the best care including effective feeding and nutrition practices. This amplifies the relevance of caregivers in the improvement of CP child survival, and justifies the need for affordable and culturally acceptable strategies.

Training of caregivers of children with CP as lay professionals has become a cost-effective strategy to address the physical rehabilitation workforce gap in some African countries. However, the effectiveness of these strategies is not properly evaluated with regards to managing malnutrition in CP. Furthermore, caregiver-initiated strategies like the positive deviance nutrition strategy although proven effective in the management of malnutrition among typically developed children, its effectiveness in the CP child population is not clear. This study seeks to evaluate the effectiveness of caregiver led strategies i.e., the positive deviance and parent facilitator training (physical rehabilitation) strategies, to malnutrition and care-giving among children and youth with CP in eastern Uganda.

Study Objective: To determine the difference in the effectiveness of positive deviance and parent facilitator training strategies to malnutrition and caregiving among children and youth with cerebral palsy in the Iganga Mayuge and Bugweri districts.

Study setting: The study will be conducted within the districts of Iganga, Mayuge and Bugweri in eastern Uganda.

Study design: This will be a 2x2 factorial quasi-randomised controlled trial assessing the effects of the Positive deviance (PD) (Yes/No) and Parent facilitator training (PFT) (Yes/No) strategies within four experimental conditions: i) Both PD and PFT, ii) Only PD, iii)Only PFT, iv) Neither PD and nor PFT(controls).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Outcomes Assessor)

Masking Description

Evaluators, Participants, and caregivers facilitating the PFT and PD training sessions will be blinded on group allocations. A group of independent outcome assessors (evaluators), not involved in the intervention, will administer the outcome measures after the interventions. These evaluators will also be blinded to group allocation to avoid reporting bias.

Eligibility Criteria

Ages
2 Years to 24 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Malnourished children and youth (<-2sd in any of height for age, weight for age and body mass index for age z-scores) with CP
  • •Caregivers of malnourished children and youth with CP

Exclusion Criteria

  • •Caregivers registered in other nutrition interventions
  • •severely malnourished children that require life-saving nutrition management

Arms & Interventions

Positive deviance (PD)

Experimental

This group will receive only the positive deviance intervention and not the PFT

Intervention: positive deviance hearth strategy (Behavioral)

Parent facilitator training (PFT)

Experimental

This group will receive only the parent facilitator training intervention and not the PD

Intervention: Parent facilitator trainings (Behavioral)

Parent facilitator and positive deviance(PFT/PD)

Experimental

This group will receive both the PD and PFT interventions

Intervention: positive deviance hearth strategy (Behavioral)

Parent facilitator and positive deviance(PFT/PD)

Experimental

This group will receive both the PD and PFT interventions

Intervention: Parent facilitator trainings (Behavioral)

Control

Active Comparator

This group will receive neither the PD nor the PFT interventions but care as usual.

Intervention: Control (Other)

Outcomes

Primary Outcomes

Nutritional status

Time Frame: 3 months

Mean weight gain

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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