A Community Based Implementation of a Toolkit and Parenting Program for Improving Brain Development in Newborns
A Community Based Implementation of a Low Cost Evidence-based Toolkit and Parenting Program for Improving Brain Development in Newborns
調査の概要
詳細な説明
Intervention:
Through this project, two intervention packages will be implemented. Firstly the toolkit will be provided to all 1080 pregnant women recruited in both the intervention and control arm of the project. The aim of providing the toolkit is to ensure that all pregnant women in the project are provided the requisite care needed from the antenatal period till delivery to limit complications and insults (both mother and especially the neonate) that can occur during pregnancy, delivery and post partum in both the mother and child. The contents of the toolkit will include:
- Gloves, Soap, a plastic sheet, a new razor blade, clean thread or narrow tape, cord clamp, aspiration bulb, bag and mask provision to the BAs, Chlorhexidine, Misoprostol, Nutritional supplements (Iron and folic acid, awareness about breastfeeding) and IEC materials
- Trainings for Birth Attendants and Link workers on aspiration and hypothermia management techniques, use of bag and mask, APGAR (also to parents), cord care, basic pregnancy care and newborn care related information, danger signs during pregnancy, postpartum, for the newborn and during the neonatal and infancy.
The second intervention package will be the implementation of the parenting program through the link workers and parents to the newborns-followed monthly over a 12 month period and will be provided to 540 women only in the intervention arm of the study. The aim of this intervention is to improve brain development among newborns through the parenting program. The Curriculum for Child Development will be adapted to the community context and used. The curriculum will be developed in the first 6 months of the project and will be designed to include:
- Monthly lessons for the parents-this will include both group and individual sessions. The parents will have one group session and one follow-up individual session respectively.
- Training guides, materials/tools and diaries for the link workers to use to log the sessions The parenting program will be implemented by the Link Workers.
Project Implementation:
The project will proceed in two phases. In Phase 1 (first two months of the project) a community assessment will be conducted, operational plans finalized, development of tools, jobs aids, IEC materials, recruiting and trainings of the link workers and TBAs and other community based birth attendants. Furthermore, linkages with LHWs will be developed at this stage. The implementation toolkits will also be prepared, with all tangible elements procured in Pakistan.
Phase 2 will focus on implementing, monitoring and documenting interventions. In the first two months of Phase 2, pregnant mothers (who will be at the beginning of their second trimester) will be recruited in both arms of the study. Recruitment will be conducted by Birth Attendants and Link Workers through the listing of pregnant women developed in consultation with various formal and informal care providers in the community. Recruitment of women will be limited to these two months. Once recruited, the women will be followed for the duration of their pregnancy and through the first year of the newborn's life. Pregnant women will be provided services included in the toolkit including nutritional supplementation. In addition, the items of the toolkit that is essential for delivery such as the Clean Delivery Kit, Chlorhexidine and Misoprostol will be provided two months before the expected delivery date of each pregnant woman. Birth attendants trained through the project will deliver the home based deliveries that will take place in the communities. Referral networks will be established with referral health facilities in case of complications. Once the newborn is delivered, those in the intervention arm of the study will be provided the parenting program for the next 12 months. The newborns in the control arm will not be provided the parenting program, but will continue to receive the standard health care services provided through routine home-based visits of Lady Health Workers. Both the intervention and control groups will undergo assessments at varying times during the 12 month period when the parenting program will be implemented in the intervention group. These assessments will include assessing the parent-child interaction and conducting the home inventory test periodically starting from when the newborn is six months old. The Bayleys Scale for Infant Development-III will also be implemented on one year old infants (cognition, motor and language subtests) in both project arms.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Islamabad、パキスタン、44000
- 募集
- Center for Global Public Health
-
コンタクト:
- Momina Salim, MPH
- 電話番号:+92-302-8558590
- メール:momina.salim@live.com
-
コンタクト:
- Tahira E Reza, MSc
- メール:reza.tahira@gmail.com
-
-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Those pregnant women who are starting the second trimester of their pregnancy;
- Those women who will continue to live in the community/village during the pregnancy period and until one year postpartum.
Exclusion Criteria:
- Those pregnant women who appear to be, in the link worker's judgment, incapable of understanding the information provided about the study (e.g., mentally incapacitated, cognitively impaired etc.)
- Not willing to participate in the study/unwilling to provide informed consent or the consent of their family.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:防止
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ:Parenting program and toolkit
The intervention arm of the study will have the low cost evidence based toolkit delivered to the the pregnant women for the duration of their pregnancy and the parenting program delivered to the newborn for 12 months.
|
The parenting program is an early childhood stimulation program aimed at newborns from their neonatal period till infancy.
The implementation of the parenting program will be conducted through the link workers and parents of the newborns.
The aim of providing the toolkit is to ensure that all pregnant women in the project are provided the requisite care needed from the antenatal period till delivery to limit complications and insults (both mother and especially the neonate) that can occur during pregnancy, delivery and post partum in both the mother and child. The contents of the toolkit will include:
|
|
他の:Control- toolkit
The control arm of the study will only have the low cost evidence based toolkit delivered to the the pregnant women for the duration of their pregnancy.
|
The aim of providing the toolkit is to ensure that all pregnant women in the project are provided the requisite care needed from the antenatal period till delivery to limit complications and insults (both mother and especially the neonate) that can occur during pregnancy, delivery and post partum in both the mother and child. The contents of the toolkit will include:
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Improvement in Bayleys Scale for Infant Development score
時間枠:one time assessment at infant's 12 month birthday
|
one time assessment at infant's 12 month birthday
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
HOME inventory test
時間枠:2 assessments at 6 months birthday and 12 month birthday of the infant
|
The Infant/Toddler (IT) HOME Inventory is designed for use during infancy (birth to age three).
It is composed of 45 items clustered into six subscales: 1) Parental Responsivity, 2) Acceptance of Child, 3) Organization of the Environment, 4) Learning Materials, 5) Parental Involvement, and 6) Variety in Experience.
Each inventory contains a group of scales to assess different aspects of the child's environment.
Each scale contains a number of items that are scored according to a glossary.
The HOME therefore provides a framework for interviewers to assess all aspects of the home environment, including parenting, that directly impact on the child.
|
2 assessments at 6 months birthday and 12 month birthday of the infant
|
|
Parent-Child Interaction assessment
時間枠:2 assessments at 6 months birthday and 12 month birthday of the infant
|
This tool will consist of a checklist that will observe the different behaviors of the mother, while the child is given an object to play with. It looks at the mother's sensitivity to the child's needs. In addition, this questionnaire also observes the mother's effort to help a child to maintain interest level in that particular game. Another checklist aimed at observing the infant will be used to observe the infant's response to the game the mother wants to play with e.g, excitement and enjoyment like clapping etc. Observation of the child's communication towards the mother and the game will also be assessed, to see whether the response is positive, negative, and to see what effort the child makes to communicate. |
2 assessments at 6 months birthday and 12 month birthday of the infant
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:James F Blanchard, MSc、University of Manitoba
- 主任研究者:Tahira E Reza, MSc、Center for Global Public Health Pakistan
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- H2014:301
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。