Enhancing Ugandan HIV-Affected Child Development With Caregiver Training (MISC)
Studienübersicht
Status
Status
Bedingungen
Bedingungen
Intervention / Behandlung
Intervention / Behandlung
Detaillierte Beschreibung
Studientyp
Studientyp
Einschreibung (Tatsächlich)
Einschreibung
Phase
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Tororo, Uganda
- Global Health Uganda
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Teilnahmekriterien
Zulassungskriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Child age 1 through 5 years of age. If more than one child in a household qualifies, they will all be included.
- HIV-infected or HIV-affected child who is an orphan (loss of one or both biological parents to HIV). In either case, child must have been born to a confirmed HIV-positive mother.
- Principal caregiver of the eligible study child is able and willing to participate in a regular treatment program. The minimum agreed to participation requirement is biweekly for entire year alternating between home and office, including regular visits at 6-month intervals to the study clinic to complete lab and developmental assessments for the study child.
Exclusion Criteria:
- Child illness or injury-based central nervous system (CNS) insults which are likely to overshadow the neurocognitive benefits of sensitive-period caregiver interventions.
- Medical history of serious birth complications, severe malnutrition, bacterial meningitis, encephalitis, cerebral malaria, or other known brain injury or disorder requiring hospitalization or continued evidence of seizure or other neurological disability.
- Current enrollment or plans for enrollment in P1 (1st grade) level of school during the first 8 months of the yearlong intervention period. Having the study child in school all day precludes necessary caregiver access to child for adequate opportunity to implement MISC training with that child. We do not expect this criterion to be problematic given that age 6 is generally the age for P1.
- Primary caregiver cannot respond to MISC or TAU intervention because of mental illness or disability.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Anzahl der Arme
Waffen und Interventionen
Teilnehmergruppe / ArmTeilnehmergruppe / Arm |
Intervention / BehandlungIntervention / Behandlung |
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Experimental: MISC
The Mediational Interventions for Sensitizing Caregivers (MISC) model developed by Professor Pnina Klein (consultant) has been used to enhance the development of children throughout the developing world, with the support of such international aid agencies as the World Health Organization (WHO), UNICEF, Norwegian Agency for Development Cooperation (NORAD), and Redd Barna (Norway).
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The Mediational Interventions for Sensitizing Caregivers
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Aktiver Komparator: Enhanced Treatment as Usual
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This nutrition/healthcare curriculum for children in poverty and affected by HIV was developed by a non-governmental organization (NGO) operating in Uganda called Uganda Community Based Association for Child Welfare (UCOBAC) with support from UNICEF.
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Was misst die Studie?
Primäre Ergebnismessungen
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Change in Child Neurodevelopment post treatment
Zeitfenster: 12 month follow up
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Mullen Scales of Early Learning
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12 month follow up
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Sekundäre Ergebnismessungen
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Change in caregiver mental health and well being
Zeitfenster: 6-, 12-, and 24-month follow ups
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Caregiver mental health will be assessed using the Hopkins Symptom Checklist (HSCL)
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6-, 12-, and 24-month follow ups
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Midterm change in child neurodevelopment
Zeitfenster: 6-month follow up
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Mullen Scales of Early Learning, Early Childhood Vigilance Test (ECVT).
Behavior Rating Inventory of Executive Function-Preschool (BRIEF-P).
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6-month follow up
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Change in long term child neurodevelopment outcomes
Zeitfenster: 24-month follow ups
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Mullen Scales of Early Learning, Early Childhood Vigilance Test (ECVT).
Behavior Rating Inventory of Executive Function-Preschool (BRIEF-P).
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24-month follow ups
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Change in child physical health and well-being
Zeitfenster: 6-, 12-, 24-month follow ups
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Measures of child growth (height and weight) and assessments of medical visits
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6-, 12-, 24-month follow ups
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Mitarbeiter und Ermittler
Sponsor
Sponsor
Mitarbeiter
Mitarbeiter
Ermittler
Ermittler
- Hauptermittler: Judy Bass, PhD, Johns Hopkins Bloomberg School of Public Health
- Hauptermittler: Michael Boivin, PhD, Michigan State University
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- Boivin MJ, Nakasujja N, Familiar-Lopez I, Murray SM, Sikorskii A, Awadu J, Shohet C, Givon D, Ruisenor-Escudero H, Schut EE, Opoka RO, Bass JK. Effect of Caregiver Training on the Neurodevelopment of HIV-Exposed Uninfected Children and Caregiver Mental Health: A Ugandan Cluster-Randomized Controlled Trial. J Dev Behav Pediatr. 2017 Nov/Dec;38(9):753-764. doi: 10.1097/DBP.0000000000000510.
- Bass JK, Opoka R, Familiar I, Nakasujja N, Sikorskii A, Awadu J, Givon D, Shohet C, Murray SM, Augustinavicius J, Mendelson T, Boivin M. Randomized controlled trial of caregiver training for HIV-infected child neurodevelopment and caregiver well being. AIDS. 2017 Aug 24;31(13):1877-1883. doi: 10.1097/QAD.0000000000001563.
- Murray SM, Familiar I, Nakasujja N, Winch PJ, Gallo JJ, Opoka R, Caesar JO, Boivin MJ, Bass JK. Caregiver mental health and HIV-infected child wellness: perspectives from Ugandan caregivers. AIDS Care. 2017 Jun;29(6):793-799. doi: 10.1080/09540121.2016.1263722. Epub 2016 Dec 13.
- Familiar I, Nakasujja N, Bass J, Sikorskii A, Murray S, Ruisenor-Escudero H, Bangirana P, Opoka R, Boivin MJ. Caregivers' depressive symptoms and parent-report of child executive function among young children in Uganda. Learn Individ Differ. 2016 Feb;46:17-24. doi: 10.1016/j.lindif.2015.01.012. Epub 2015 Jan 30.
- Familiar I, Murray S, Ruisenor-Escudero H, Sikorskii A, Nakasujja N, Boivin MJ, Opoka R, Bass JK. Socio-demographic correlates of depression and anxiety among female caregivers living with HIV in rural Uganda. AIDS Care. 2016 Dec;28(12):1541-1545. doi: 10.1080/09540121.2016.1191609. Epub 2016 May 30.
- Bass JK, Nakasujja N, Familiar-Lopez I, Sikorskii A, Murray SM, Opoka R, Augustinavicius J, Boivin MJ. Association of caregiver quality of care with neurocognitive outcomes in HIV-affected children aged 2-5 years in Uganda. AIDS Care. 2016;28 Suppl 1(sup1):76-83. doi: 10.1080/09540121.2016.1146215. Epub 2016 Feb 17.
- Seffren V, Familiar I, Murray SM, Augustinavicius J, Boivin MJ, Nakasujja N, Opoka R, Bass J. Association between coping strategies, social support, and depression and anxiety symptoms among rural Ugandan women living with HIV/AIDS. AIDS Care. 2018 Jul;30(7):888-895. doi: 10.1080/09540121.2018.1441969. Epub 2018 Feb 22.
- Boivin MJ, Augustinavicius JL, Familiar-Lopez I, Murray SM, Sikorskii A, Awadu J, Nakasujja N, Bass JK. Early Childhood Development Caregiver Training and Neurocognition of HIV-Exposed Ugandan Siblings. J Dev Behav Pediatr. 2020 Apr;41(3):221-229. doi: 10.1097/DBP.0000000000000753.
- Ruisenor-Escudero H, Sikorskii A, Familiar-Lopez I, Persaud D, Ziemniak C, Nakasujja N, Opoka R, Boivin M. Neruodevelopmental Outcomes in Preschool Children Living With HIV-1 Subtypes A and D in Uganda. Pediatr Infect Dis J. 2018 Dec;37(12):e298-e303. doi: 10.1097/INF.0000000000002097.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Studienbeginn
Primärer Abschluss (Tatsächlich)
Primärer Abschluss
Studienabschluss (Tatsächlich)
Studienabschluss
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Zuerst gepostet
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes Update gepostet
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
Andere Studien-ID-Nummern
- JHU-MSU-UGANDA-2012
- R01HD070723-01 (US NIH Stipendium/Vertrag)
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