Reintegration of Children Into Family-based Care in Uganda

NCT03498469 | Completed

• 1 other identifier: 170901
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parenting

Keywords

reintegration, reunification, child development

Outcome Measures

Primary Outcomes (19)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (3)

• Child Anthropometry: Height

  Baseline, 6-month post- reunification and 12-month post- reunification follow-u

• Child Anthropometry: Weight

  Baseline, 6-month post- reunification and 12-month post- reunification follow-u

• Satisfaction of the intervention

  Baseline, 6-month post- reunification and 12-month post- reunification follow-up

Other Outcomes (6)

• Moderator: Child, home caregiver, and household characteristics

  Baseline

• Moderator: Home Caregiver's Marital Quality

  Baseline, 6-month post- reunification and 12-month post- reunification follow-up

• Moderator: Home Caregiver's exposure to Intimate partner violence

  Baseline, 6-month post- reunification and 12-month post- reunification follow-u

Study Arms (2)

No Parenting program

ACTIVE COMPARATOR

Participants assigned to this comparison arm will receive a standardized reintegration package that includes individualized case management support and a reunification cash grant. Individualized case management will consist of a caseworker-developed individualized care plan with routine caseworker visits at the household level. At a minimum, each family will be visited on a monthly basis during the first 6 months post-placement and then every other month for the next 9 months. For the cash grant, the family of each enrolled child will receive a reunification cash grant in the Ugandan Shilling equivalent of $125, administered in two equal disbursements. It is designed to offset the cost of child care.

Behavioral: Standardized reintegration package

Parenting program

EXPERIMENTAL

Those in the intervention arm will receive an enhanced reintegration package of services that consist of the standard package (case management and cash grant) plus a parenting program called 'Esanyu Mu Maka' or Happiness in the Home. The parenting curriculum used will be an adaptation of the evidence-based Sinovuyo Kids curriculum, tailored for caregivers of children age 1 to 13 years. It will have specifically designed components to address parenting challenges under reunification/reintegration conditions and to support the child and caregiver in building their relationship. It will be delivered at the household level by project trained parenting facilitators. The program will consist of approximately 13 bi-weekly sessions, which will be delivered over the course of 7 months.

Behavioral: Enhanced reintegration package

Interventions

Standardized reintegration package BEHAVIORAL

Participants assigned to this comparison arm will receive a standardized reintegration package that includes individualized case management support and a reunification cash grant Individualized case management will consist of a caseworker-developed individualized care plan with routine caseworker visits at the household level. Home visitation will begin during the family assessment and preparation stages and continue throughout the 15-month post-reunification follow-up period. For the cash grant, the family of each enrolled child will receive a reunification cash grant in the Ugandan Shilling equivalent of $125, administered in two equal disbursements. It is designed to offset the cost of child care.

No Parenting program

Enhanced reintegration package BEHAVIORAL

Participants assigned to this arm will receive an enhanced reintegration package that consists of the parenting program, individualized case management, and the reunification grant. will be delivered at the household level by project trained parenting facilitators. The program will consist of approximately 13 bi-weekly sessions, which will be delivered over the course of 7 months. The individualized case management and the reunification grant will be similar to those in the comparison arm.

Also known as: 'Esanyu Mu Maka' or Happiness in the Home

Parenting program

Eligibility Criteria

• Age: 1 Year - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Westat: lead
• Makerere University: collaborator

Study Sites (1)

Makerere University

Kampala, Uganda

Location

Related Publications (4)

• 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.

  PMID: 28881303 BACKGROUND

• 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. doi: 10.1016/j.lindif.2015.01.010. Epub 2015 Jan 16.

  PMID: 27212870 BACKGROUND

• 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. doi: 10.1186/s13063-016-1658-9.

  PMID: 27829445 BACKGROUND

• 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.

  PMID: 28964563 BACKGROUND

Study Officials

• Eileen Ihrig, MSW

  Catholic Relief Services

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Randomized assignment will be done by the individuals who are evaluating the study outcomes, but will be blind to participant assignment
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are assigned to either of the two arms in parallel for the duration of the study

Study Record Dates

• First Submitted: December 8, 2017
• First Posted: April 13, 2018
• Study Start: December 7, 2017
• Primary Completion: June 30, 2019
• Study Completion: October 1, 2019
• Last Updated: October 21, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)