Parenting Clinical Trial
Official title:
Keeping Children in Healthy and Protective Families: Effects of a Household-based Parenting Program on Reintegration of Children Into Family-based Care in Uganda
NCT number | NCT03498469 |
Other study ID # | 170901 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | December 7, 2017 |
Est. completion date | October 1, 2019 |
Verified date | October 2019 |
Source | Westat |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The proposed study will be an individually randomized controlled trial with children (age 1
to 13 years at the time of screening for inclusion in the study) living in residential care,
reintegrated back into family-based care, in Uganda. It is designed to evaluate the impact of
adding a household-based parenting program to a standardized reintegration package that
includes individualized case management support and a reunification cash grant, aimed at
improving the reintegration of children living in residential care back into family-based
care. The study population will include children living in residential care facilities (RCFs)
in Mpigi, Mukono, Masaka and Greater Masaka districts in Uganda.
Study participants will be randomized to one of two arms of the study: the comparison arm and
the intervention arm. The target sample size is 640 children with 320 in each arm of the
study. Children assigned to the comparison arm will receive a standard reintegration package
that includes individualized case management support and a reunification cash grant. Those in
the intervention arm will receive the enhanced reintegration package that includes
individualized case management support, reunification cash grant and a parenting
intervention. Data will be collected at baseline (while the child is still living in the
RCF), 6 months post-placement and 12 months post-placement.
Data will be collected in the local language by a project trained local data collection
partner on the following six domains of reintegration: Child health and development,
Psychosocial health and wellbeing of the child and primary caregiver, Protection and safety
of the child, Caregiver-child relationship, Child's and caregiver's sense of social and
community belonging, Education access, quality, and achievement (where age-appropriate).
The sources of data are a) interviews with primary caregiver, b) interviews with RCF
caregiver, c) interviews with older children (8-13 years of age), d) standardized assessments
of child cognitive functioning for all the study children, and e) focus groups and interviews
with participants, parenting facilitators, and case managers.
Status | Completed |
Enrollment | 77 |
Est. completion date | October 1, 2019 |
Est. primary completion date | June 30, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 1 Year to 13 Years |
Eligibility |
Inclusion Criteria: - The case assessment indicates that the child can be reunified with the family/kin. - Child is being reintegrated with family or kin in one of the study districts. Exclusion Criteria: - Child requires an alternative care arrangement including foster care, adoption, or independent/group home living. - Child has severe developmental disabilities. - Children whose caregivers plan to send them boarding school |
Country | Name | City | State |
---|---|---|---|
Uganda | Makerere University | Kampala |
Lead Sponsor | Collaborator |
---|---|
Westat | Makerere University |
Uganda,
Bangirana P, Opoka RO, Boivin MJ, Idro R, Hodges JS, John CC. Neurocognitive domains affected by cerebral malaria and severe malarial anemia in children. Learn Individ Differ. 2016 Feb;46:38-44. Epub 2015 Jan 16. — View Citation
Herrero Romero R, Hall J, Cluver L, Meinck F. Can supportive parenting protect against school delay amongst violence-exposed adolescents in South Africa? Child Abuse Negl. 2018 Apr;78:31-45. doi: 10.1016/j.chiabu.2017.09.025. Epub 2017 Sep 28. — View Citation
Lachman JM, Cluver L, Ward CL, Hutchings J, Mlotshwa S, Wessels I, Gardner F. Randomized controlled trial of a parenting program to reduce the risk of child maltreatment in South Africa. Child Abuse Negl. 2017 Oct;72:338-351. doi: 10.1016/j.chiabu.2017.08.014. Epub 2017 Sep 4. — View Citation
Tomlinson M, Skeen S, Marlow M, Cluver L, Cooper P, Murray L, Mofokeng S, Morley N, Makhetha M, Gordon S, Esterhuizen T, Sherr L. Improving early childhood care and development, HIV-testing, treatment and support, and nutrition in Mokhotlong, Lesotho: study protocol for a cluster randomized controlled trial. Trials. 2016 Nov 9;17(1):538. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Moderator: Child, home caregiver, and household characteristics | Basic caregiver and child demographic information will be asked using items adapted from validated instruments such as the UNICEF Multiple Indicator Cluster Surveys (MICS) and the Demographic and Health Survey (DHS), as well as the Sinovuyo questionnaires. For example, a household roster (similar to MICS and the DHS) is collected in the Caregiver baseline questionnaire, containing questions on household composition and HH members' age, sex, literacy, education level, and relationship to the child being reunified. Other household characteristics are also collected in the Caregiver baseline questionnaire, such as dwelling characteristics, household assets (similar to the household assets module in the DHS, used to measure HH wealth). We also added questions specific to the current study such as the presence of child's biological parents (including reasons for absence), reasons for living in the RCF. | Baseline | |
Other | Moderator: Home Caregiver's Marital Quality | The home caregiver's marital quality, or quality of relationship with the current partner, will be assessed using the Quality of Marriage Index (QMI, Norton, R.; 1983). The QMI is a 5-item measure of marital satisfaction. Respondents answer the items on a 7- point scale ranging from 1 (strongly disagree) to 7 (strongly agree). The QMI will be administered to home caregivers who are in a current relationship. | Baseline, 6-month post- reunification and 12-month post- reunification follow-up | |
Other | Moderator: Home Caregiver's exposure to Intimate partner violence | The home caregiver's exposure of intimate partner violence will be measured by short form of the Revised Conflict Tactics Scale (CTS2S, Straus & Douglas, 2004). The CTS2S is a 20-item measure of both the extent to which partners in a dating, cohabiting, or marital relationship engage in psychological and physical attacks on each other, and their use of reasoning or negotiation to deal with conflicts. All items are answered by the respondent using a 5-point Likert scale format ranging from "strongly disagree" to "strongly agree". | Baseline, 6-month post- reunification and 12-month post- reunification follow-u | |
Other | Moderator: Alcohol use in home caregivers | The Alcohol Use Disorders Identification Test (AUDIT) measures the use of alcoholic beverages by the caregiver (World Health Organization, Babor, Higgins-Biddle, Saunders, & Monteiro, 2001). AUDIT has been used in many studies in Africa, more recently in Lesotho (Tomlinson et al., 2016), to assess alcohol consumption and drinking behaviors. We selected three questions pertaining to the frequency of alcohol use in the past year. Used in The AUDIT will be administered to the home caregiver | Baseline, 6-month post- reunification and 12-month post- reunification follow-up | |
Other | Moderator: Child disability | Child disability will be assessed using the disability module from the UNICEF Multiple Indicator Cluster Surveys (MICS) (Cappa 2011).. The "10 Questions" (TQ) Child disability module, which was standardized in the 3rd round of MICS surveys (MICS3) in 2005-2006, uses questions posed to the parent or caregiver of children aged 2-9. These questions focus on activity limitations and participation restrictions, and they rely on observations of the caregiver of the difficulty the child may experience in seeing, hearing, walking or climbing steps, remembering, understanding and communicating in his/her usual language. Response options have been simplified to "yes" or "no" for each item. | Baseline, 6-month post- reunification and 12-month post- reunification follow-up | |
Other | Moderator: Caregiver's experience of abuse during childhood | Caregiver's experience of abuse as a child will be assessed using an adapted version of the International Society for the Prevention of Child Abuse and Neglect's Child Abuse Screening Tools - Retrospective Version (ICAST-R; Dunne, Zolotorb, Runyanb, Andreva-Millerc, Yuen, Chood, Dunnea, S., ... Youssefj, R. (2009); Lachman et al., 2017). We use the version with 7 items that was adapted for the Sinuvuyo study (Cluver et al., 2016), by selecting a subset of the items pertaining to sexual abuse with possible responses as "yes" or a "no". This scale utilizes parent self-report of experiences during their own childhood to assess the history of incidence of physical maltreatment, verbal abuse, and sexual abuse. In this study, incidence of past history of child maltreatment will be scored as dichotomous variables for physical, verbal, and sexual abuse, as well as an overall indication of previous child abuse (0 = no abuse; 1 = previous abuse). | Baseline | |
Primary | Increase in positive parenting behaviors (supportive positive behaviors, and setting limits) | Positive parenting behaviors of parental involvement and setting limits will be measured by the Parenting Young Children Scale (PARYC; McEachern, Dishion, Weaver, Shaw, Wilson & Gardner, 2012). The PARYC is a measure designed to address parenting behaviors relevant for the caregivers of young children in the past month. The PARYC has been used widely including in Africa such as in South Africa as part of the Sinovuyo Teen trial (Cluver et al., 2016). It has 21 items measuring the occurrence of specific parental behavior towards children during the previous month on a 7-point Likert scale (0 = never; 6 = always). We will use subscales of Supporting Positive Behavior for children aged 1-13 years (7 items), and Setting Limits for ages 1-5 (7 items). In our study, both subscales of the PARYC will be administered to the Home and the RCF caregivers; the Supporting Positive Behavior subscale will be administered to children 8 years and above, with a modified 5-point rating scale. | Baseline, 6-month post- reunification and 12-month post- reunification follow-up | |
Primary | Increase in positive parenting behaviors (positive involvement and monitoring/supervision) | Positive parenting behaviors of positive involvement and monitoring/supervision will be measured using the Alabama Parenting Questionnaire (APQ; Frick 1991). The APQ has been used widely including in studies in Africa, such as in South Africa (Casale et al., 2015) and as part of the Sinovuyo Teen parenting program (Cluver et al., 2016). The APQ has 42 items related to the etiology of child externalizing problems. Respondents are asked to select how often various actions (e.g., "Your child is home without adult supervision.") happen typically on a 5-point Likert-like scale (1 = never; 5 = always). For this study, we will be using the APQ subscales of Involvement for children aged 1-13 years (10 items), and Monitoring and Supervision subscale for ages 6-13 (10 items). In our study, the APQ child form will be administered to children 8 years and older; the APQ parent form will be administered to the home and the RCF caregiver. | Baseline, 6-month post- reunification and 12-month post- reunification follow-up | |
Primary | Increased levels of secure attachment | Attachment behaviors of children aged 1 to 6 years will be assessed by the Disturbances in Attachment Interview (Smyke & Zeanah, 1999). This is a semi-structured interview with questions to the child's primary caregiver about the child's typical behaviors. The DAI includes 12 items - 8 questions on Disturbances of Non-attachment and 4 questions on Secure-Base distortions. Each item is explored through a series of probes. Trained interviewers rate each item as "0" = none or never, 1= somewhat or sometimes, and 2 = considerable or frequently; responses are summed with higher scores indicating greater disturbances in attachment. The DAI will be administered to the RCF caregiver at baseline, and the Home caregiver 6- and 12-months follow-up. | Baseline, 6-month post- reunification and 12-month post- reunification follow-up | |
Primary | Decrease in Child Problem Behaviors | Child Problem Behaviors will be measured by the Child Behavior Checklist (CBCL, Achenbach 1992). The CBCL has been used widely including in studies in Africa, such as in South Africa as part of the Sinovuyo Teen parenting program (Cluver et al., 2016). CBCL is a caregiver-report questionnaire on which the child will be rated as either a 0 ("Not True"), 1 ("Somewhat or Sometimes True"), or a 2 ("Very True or Often True"), on various behavioral and emotional problems. It assesses internalizing (i.e., anxious, depressive, and overcontrolled) and externalizing (i.e., aggressive, hyperactive, noncompliant, and undercontrolled) behaviors. We will use the two versions, one for children aged 1 to 5 years, and another for children aged 6 to 13 years. CBCL will be rated by both the home caregiver as well as the RCF caregiver. | Baseline, 6 months post- reunification and 12-month post-reunification follow-up | |
Primary | Better attitudes towards physical punishment in children | Attitudes towards discipline and physical punishment will be measured by using items from the International Child Abuse Screening Tool Attitudes measure, developed for the Sinovuyo study (Cluver et al., 2016). The ICAST-Attitudes has 3 items that measure attitudes towards physical punishment of children using the example of a child who is "always getting into trouble". Respondents are asked how 'good' the disciplining tactics are using a scale of 1 ("very good") to 5 ("very bad"). The measure will be administered to the home caregiver, the RCF caregiver, and the 8+ child. | Baseline, 6-month post- reunification and 12-month post- reunification follow-up | |
Primary | Lowered report of child abuse | Child abuse will be measured using an abbreviated version of the International Society for the Prevention of Child Abuse and Neglect child and caregiver version of the International Child Abuse Screening Tool (Reduced ICAST-Trial). The Reduced ICAST has questions that pertains to incidents of violence in the past months. The ICAST measures three types of abuse: physical abuse, emotional abuse, and sexual abuse. In this study, the response code was adapted to a frequency scale from 0 to more than 8 times as certain behavior occurred in the past month. The Reduced ICAST will be administered to the RCF caregiver and the 8+ child. The RCF caregiver version has 14 items. The 8+ Child version has 20 items and includes questions on whether the child has asked for help relating to the questions that are not part of the ICAST tool. The investigators will also assess frequency of overall abuse by summing all of the subscales as well as for each individual subscale. | Baseline, 6-month post- reunification and 12-month post- reunification follow-up | |
Primary | Increase in child Cognitive functioning | Cognitive functioning of younger children, aged 1 to 4 years, will be assessed by the Mullen Scales Early Learning (MSEL; Mullen, 1995). MSEL is an individually administered standardized measure of cognitive ability and motor development, which has been used in many studies in Uganda and other countries in Africa (Boivin et al., 2013). We will be administering all five scales of MSEL: Gross Motor, Fine Motor, Visual Reception, Receptive Language, and Expressive Language that are combined into an Early Learning Composite score. Raw scores will be converted to standardized score that will yield a composite of the Mental Processing Index (MPI). Cognitive functioning of older children, aged 5 to 13, will be assessed by the Kaufman Assessment Battery for Children (KABC-II; Kaufman & Kaufman, 2004). It is an individually administered standardized measure of sequential and simultaneous processing, learning, reasoning, and crystallized knowledge ability, which has been used in many studies |
Baseline, 6-month post- reunification follow-up | |
Primary | Increased access to food | Household food security is measured at all 3 time points (in the Caregiver questionnaire) by the Household Hunger Scale (HHS, Ballard, Coates, Swindale, & Deitchler, 2011). The HHS is a series of three questions regarding household food insecurity in the prior month (i.e., "was there ever no food to eat of any kind…?" [and, if so, how often: rarely (1-2 times), sometimes (3-10 times), often (more than 10 times)]; "did you or any member of your household go to sleep at night hungry…?" [and how often]; and "did you or any household member go a whole day and night without eating anything at all because there was not enough food?" [and how often]). The HHS will be administered only to the home Caregiver at all time points. | Baseline, 6-month post- reunification and 12-month post- reunification follow-up | |
Primary | Increased access to health care | Children's access to health care will be measured by questions on availability of shelter and clothing, general health, schedule of immunizations, and access to medical care. These questions were based on existing OVC tools and questions used in the Sinovuyo study (Cluver et al., 2016). These questions will be administered to the RCF caregiver and the 8+ child. The schedule of immunizations will be obtained from the child's vaccination card at the RCF. | Baseline, 6-month post- reunification and 12-month post- reunification follow-up | |
Primary | Increase in child and caregiver's Self-Esteem | Child and the home caregiver's self-esteem will be assessed by Rosenberg Self-Esteem Scale (Rosenberg, 1965), which is a 10-item scale that measures global self-worth by measuring both positive and negative feelings about the self. All items are answered by the respondent using a 4-point Likert scale format ranging from "strongly agree" to "strongly disagree". The self-esteem scale will be administered to the Home Caregiver and the 8+ Child. | Baseline, 6-month post- reunification and 12-month post- reunification follow-up | |
Primary | Increase in Home Caregiver's Psychosocial Health | The home caregiver's symptoms of psychosocial health will be assessed by The Shona Symptom Questionnaire (SSQ) that was developed in sub-Saharan Africa (Patel, Simunyu, Gwanzura, Lewis, & Mann, 1997). The SSQ consists of 14 "yes/no" questions pertaining to common symptoms of mental disorder, and idioms or distress of primary care attenders. The items are a mixture of emic and etic phenomena, and are self-rated by the respondent. The SSQ will be administered only to the Home Caregiver at all time points. | Baseline, 6-month post- reunification and 12-month post- reunification follow-up | |
Primary | Decrease in Parenting Stress | Parenting stress of the home caregiver will be measured using the Parental Stress Scale (PSS; Berry & Jones, 1995). The PSS has been used widely including in studies in Africa, such as in South Africa as part of the Sinovuyo Teen parenting program (Cluver et al., 2016). PSS is a self-report scale that contains 18 items representing pleasure or positive themes of parenthood (emotional benefits, self-enrichment, personal development) and negative components (demands on resources, opportunity costs and restrictions). Respondents are asked to agree or disagree with items in terms of their typical relationship with their child or children and to rate each item on a five-point scale ranging from "strongly disagree" (1) to "strongly agree" (5). The PSS will be administered only to the Home Caregiver at all time points. | Baseline, 6 months post- reunification and 12-month post-reunification follow-up | |
Primary | Decrease in child and caregiver's loneliness | Home caregiver's and child's (8+ years) loneliness will be measured using UCLA Loneliness scale (Version 3, Russell, D. (1996)), designed to measure one's subjective feelings of loneliness as well as feelings of social isolation. We will be using the 3-item scale (Hughes, Waite, Hawkley, & Cacioppo, 2004) that will be self-rated on a 4-point scale as either O ("I often feel this way"), S ("I sometimes feel this way"), R ("I rarely feel this way"), or N ("I never feel this way"). | Baseline, 6-month post- reunification and 12-month post- reunification follow-up | |
Primary | Decrease in child's depressive symptoms | Children's Depression Inventory (CDI; Kovacs, 2011) will be used to assess self-rated depressive symptoms of older children (aged 8 yrs. and above). CDI measures cognitive, affective, and behavioral symptoms of depression such as depressed mood, hedonic capacity, vegetative functions self-evaluation and interpersonal behaviors in the past two weeks. It covers the consequences of depression as they relate to children and functioning in school and with peers. We will use the 2nd edition (CDI2) with 12 items. For each item the child has three possible answers; 0 indicating an absence of symptoms, 1 indicating mild symptoms, and 2, definite symptoms. | Baseline, 6-month post- reunification and 12-month post- reunification follow-up | |
Primary | Increase in Protective Factors and Resilience | The presence of a caring adult as a protective factor will be assessed using questions from the core module of The California Healthy Kids Survey (CHKS, 2014; CA Department of Education, Version H18 - Fall 2014 - Spring 2015). CHKS has been administered as a comprehensive, youth risk behavior and resilience survey . The four items pertain to child's perception of the availability of a caring adult. The items are rated on a 4-point scale: Not at all true, A little true, Pretty much true, and very much true." Of the original 6 questions, 2 questions were removed at the piloting stage. In the present study, this measure will be administered to the older children (8+ years). | Baseline, 6-month post- reunification and 12-month post- reunification follow-up | |
Primary | Increased levels of social support for caregiver and child | Perceived social support will be measured using the Medical Outcome Study Social Support Questionnaire (MOS-SSQ, Sherbourne & Stewart, 1991). The MOS-SSQ has been used widely including in studies in Africa, such as in South Africa (Lachman et al., 2014) and as part of the Sinovuyo Teen parenting program (Cluver et al., 2016). The MOS-SSQ is a 19-item survey that measures emotional/informational support, tangible/instrumental support, affectionate support, and positive social interaction. Respondents report on the frequency of how often they receive support (e.g., "someone you can count on to listen to when you need to talk") on a Likert-like scale of 1 to 5 (1 = none of the time; 5 = all of the time). Total scores are calculated by averaging the scores for each item and then transformed into a 0 to 100 scale. The MOS-SSQ will be administered to the Home Caregiver and the 8+ Child. | Baseline, post- intervention and 12-month post-intervention follow-up | |
Primary | Increased sense of community belonging for caregiver and child | Sense of community belonging will be measured by an adapted version of the RETRAK and ASPIRE's 3-item sense of belonging feelings of acceptance and involvement in the community. ASPIRES Family Care: Longitudinal Project Assessment Research, Child Integration Status Tool, Version 2.0, 2016. The measure will be administered to the Home caregiver and the 8+ child. | Baseline, 6-month post- reunification and 12-month post- reunification follow-up | |
Primary | School enrollment | School enrollment will be assessed based on self-reports. Questions on school enrollment, type of school, reasons for lack of enrollment, number of days missed, current grade, previous grade, repetition of a grade, will be asked of the RCF caregiver, home caregiver, and the 8+ child. | Baseline, 6-month post- reunification and 12-month post- reunification follow-up | |
Primary | Satisfaction with school | Children's and caregiver's satisfaction with child's schooling will be measured by a 3-item questionnaire; children's feeling safe at school, having a sense of belonging at school. | Baseline, 6-month post- reunification and 12-month post- reunification follow-up | |
Secondary | Child Anthropometry: Height | Children's height (in centimeters) based on standardized measurement of the child at the RCF. | Baseline, 6-month post- reunification and 12-month post- reunification follow-u | |
Secondary | Child Anthropometry: Weight | Children's weight (in kilograms) based on standardized measurement of the child at the RCF. | Baseline, 6-month post- reunification and 12-month post- reunification follow-u | |
Secondary | Satisfaction of the intervention | Satisfaction and feasibility of the intervention will be measured qualitatively. Interviews and focus groups will be conducted of the caregivers, children, parenting facilitators, and case managers. The interviews/focus groups will be audio recorded and coded to assess a) the satisfaction and feasibility of the intervention components for children and caregivers as well as the program implementers (parenting facilitators and case managers); b) effect of the individual intervention components on the reintegration process from the perspectives of the target audience and implementers, and c) barriers and facilitators to implementing the parenting program. | Baseline, 6-month post- reunification and 12-month post- reunification follow-up |
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