跳至主要内容
临床试验/NCT03036176
NCT03036176已完成不适用

"Effects of a Play-based Family Centered Psychomotor/Psychosocial Stimulation on Recovery of Severely Malnourished Children of 6-60 Months of Age During Nutritional Rehabilitation in the Jimma Zone of Ethiopia"

Hasselt University0 个研究点目标入组 339 人开始时间: 2011年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
339
主要终点
Social-emotional outcome

研究概览

简要总结

Children with severe acute malnutrition (SAM) are at serious risks that compromise their growth and development. Studies have shown the benefits of psychosocial intervention in mitigating the negative consequences of SAM. However, such intervention studies have targeted the critical period in child development and thus focused on children under three years of age. Dietary rehabilitation is usually included as part of the intervention package. Moreover, these young children in such studies customarily obtain more care than older ones and have access to breast milk, more frequent interaction with mother and other caregivers in the family. Therefore, effects of psychosocial interventions targeting such age groups may be different for older children. Much is not known if children older than three years of benefit from similar interventions, and if family-based psychomotor/psychosocial intervention can benefit SAM children in low income contexts such as Ethiopia where access to balanced diet remains hardly possible. In Ethiopia, one of the poorest countries in the world, many children are admitted to hospital for treatment due to SAM. The nutritional rehabilitation unit at hospitals provide dietary treatment to the SAM children who are also treated for related illnesses and complications. Once discharged from hospital, however, the SAM children return to the same poor home environments with inadequate care and unbalanced diets. The main objective of this study was to evaluate the effect of play-based family-centered psychomotor/psychosocial stimulation on linear growth, nutritional status and developmental outcomes of under-six SAM children in the Jimma Zone, south west Ethiopia. This was done by randomly assigning the SAM children admitted to Jimma University's Specialized Referral Teaching Hospital into control and intervention groups. Both groups were receiving the routine medical and dietary treatment services. The intervention group additionally received play-based psychomotor/psychosocial stimulation. Caregivers, supported by periodic visits made to their homes, continued the simulation. Measurements were taken after six months of home follow-up. It was hypothesized that the intervention would significantly improve some of the developmental skills of these children, and that the effect may be age-dependent.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
6 Months 至 66 Months(Child)
性别
All
接受健康志愿者
否

入选标准

  • •SAM children who were admitted for medical treatment and nutritional rehabilitation after being confirmed by physicians to be severely acutely malnourished.
  • •Inclusion criteria were:
  • •children between 6 to 60 months of age
  • •of Transition Phase i.e., Phase II (no medical complications) and, whose wasting was severe (weight for height or weight for length less than 70% of the median on National Centre for Health Statistics of USA; or
  • •with a low mid upper arm circumference (MUAC), i.e., less than 110 mm with a length greater than 65 cm; or,
  • •having bilateral pitting edema,

排除标准

  • •SAM children
  • •who were completely deaf or blind,
  • •who had complications that hinder mobility for play,
  • •whose primary caregiver was not able to provide stimulation due to physical or mental disability,
  • •who were from far or inaccessible distance for follow-up

研究组 & 干预措施

SAM intervention group

Other

Children in the intervention group received routine medical treatment and nutritional rehabilitation services in hospital; their primary caregivers were given basic orientations on child care, feeding and nutrition. Children attended play-based stimulation sessions in which trained nurses demonstrated caregivers on how to stimulate the SAM child using play materials and facilities at playroom and playground of the hospital. After discharge from hospital, they were followed up at home and visited three times over a period of six months. During the visits, new play materials were provided and caregivers were shown how to use them to stimulate the SAM child.

干预措施: Play-based family centered stimulation (Behavioral)

SAM control Group

Other

The control children received routine medical treatment and nutritional rehabilitation services in hospital. Though they had access to playground facilities neither the control children nor their caregivers had access to the playroom materials and the basic orientation on child care, feeding and stimulation.

干预措施: no intervention (Other)

结局指标

主要结局

Social-emotional outcome

时间窗: 6 months after discharge

The Ages and Stages questionnaire: Social emotional (ASQ:SE) was used to test Social emotional outcome \& a child's total behavior score was obtained by adding up scores on each of the items

Language outcome

时间窗: 6 months after discharge from hospital

Denver II-Jimma was used to test language outcome \& the total number of items successfully performed was counted.

Personal-Social outcome

时间窗: 6 months after discharge

Denver II-Jimma was used to test Personal-social outcome \& the total number of items successfully performed was counted.

Fine motor outcome

时间窗: 6 months after discharge

Denver II-Jimma was used to test Fine motor outcome \& the total number of items successfully performed was counted.

Gross motor outcome

时间窗: 6 months after discharge

Denver II-Jimma was used to test Gross motor outcome \& the total number of items successfully performed was counted.

Language outcome

时间窗: baseline

Denver II-Jimma was used to test language outcome \& the total number of items successfully performed was counted.

Language outcome

时间窗: at discharge from the hospital (on average at 2 weeks)

Denver II-Jimma was used to test language outcome \& the total number of items successfully performed was counted.

Personal-Social outcome

时间窗: baseline

Denver II-Jimma was used to test Personal-social outcome \& the total number of items successfully performed was counted.

Personal-Social outcome

时间窗: at discharge from the hospital (on average at 2 weeks)

Denver II-Jimma was used to test Personal-social outcome \& the total number of items successfully performed was counted.

Fine motor outcome

时间窗: baseline

Denver II-Jimma was used to test Fine motor outcome \& the total number of items successfully performed was counted.

Fine motor outcome

时间窗: at discharge from the hospital (on average at 2 weeks)

Denver II-Jimma was used to test Fine motor outcome \& the total number of items successfully performed was counted.

Gross motor outcome

时间窗: baseline

Denver II-Jimma was used to test Gross motor outcome \& the total number of items successfully performed was counted.

Gross motor outcome

时间窗: at discharge from the hospital (on average at 2 weeks)

Denver II-Jimma was used to test Gross motor outcome \& the total number of items successfully performed was counted.

Social-emotional outcome

时间窗: baseline

The Ages and Stages questionnaire: Social emotional (ASQ:SE) was used to test Social emotional outcome \& a child's total behavior score was obtained by adding up scores on each of the items

Social-emotional outcome

时间窗: at discharge from the hospital (on average at 2 weeks)

The Ages and Stages questionnaire: Social emotional (ASQ:SE) was used to test Social emotional outcome \& a child's total behavior score was obtained by adding up scores on each of the items

次要结局

  • Linear growth(6 months after discharge from hospital)
  • Nutritional status (Weight -for-age)(6 months after discharge from hospital)
  • Nutritional status (Weight for height/length)(6 months after discharge from hospital)
  • Nutritional status (Mid-upper-arm circumference)(6 months after discharge from hospital)
  • Linear growth(baseline)
  • Linear growth(at discharge from the hospital (on average at 2 weeks))
  • Nutritional status (Weight -for-age)(baseline)
  • Nutritional status (Weight -for-age)(at discharge from the hospital (on average at 2 weeks))
  • Nutritional status (Weight for height/length)(baseline)
  • Nutritional status (Weight for height/length)(at discharge from the hospital (on average at 2 weeks))
  • Nutritional status (Mid-upper-arm circumference)(baseline)
  • Nutritional status (Mid-upper-arm circumference)(at discharge from the hospital (on average at 2 weeks))

研究者

发起方
Hasselt University
申办方类型
Other
责任方
Principal Investigator
主要研究者

prof. dr. Marita Granitzer

prof.dr.

Hasselt University

相似试验