Sinovuyo Caring Families Project - Pilot Trial

Study Overview
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Brief Summary
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This pilot feasibility trial will evaluate the Sinovuyo Caring Families Program in a small-scale randomized controlled trial in Cape Town, South Africa (n=60 families). The pilot study will use a mixed-methods approach to intervention evaluation. Self-report and observed quantitative data for intervention and control groups will be collected at pre-test and post-test evaluation. Primary outcomes will include parent-reports and observations of child behavior problems. In addition, as an exploratory study, this phase will examine initial pre-post intervention effects for potential mediating factors of parenting behavior, parental stress, parental depression, and perceived social support. However, this phase will not test mediation effects due to small sample sizes. Quantitative assessments will also collect data on program fidelity, exposure/adherence, participant engagement, and satisfaction. Furthermore, qualitative focus groups with intervention participants and group leaders will examine issues of program feasibility, content, deliver, and satisfaction. Randomization will be done on an individual level and include a wait-list control group that will receive the intervention 3 months after the post-test evaluation. Results from the feasibility pilot study will be shared with intervention partners and advisory groups. If necessary, final program adjustments will be made prior to further testing. Results will also be disseminated to community forums, local organizations, government stakeholders, and via academic conferences. Research hypotheses: Hypothesis 1: Children in the intervention group will demonstrate reduced observed and parent-reported child behavior problems in comparison to the control group. Hypothesis 2: Parents in the intervention group will demonstrate increased observed and self-reported positive parenting outcomes and decreased observed and self-reported harsh and inconsistent parenting outcomes in comparison to the control group. Hypothesis 3: Parents in the intervention group will demonstrate decreased parental depression and parental stress outcomes and increased perceived social support outcomes in comparison to the control group. Hypothesis 4: The Sinovuyo Caring Families Program will be implemented with an acceptable degree of program fidelity, exposure/adherence, and participant satisfaction.

Official Title
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Sinovuyo Caring Families Project - Pilot Randomised Controlled Trial of a Parenting Program to Reduce Child Behavior Problems in Xhosa Children Ages 3 to 8 in South Africa

Conditions
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Child Behavior, Parenting, Child Abuse

Intervention / Treatment
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* Behavioral: Parenting Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: isiXhosa-speaking adults above the age of 18 primary guardians of children aged 3-8 from Khayelitsha, Cape Town reside in the same household as child for at least 4 nights per week Score 11 or more on Eyberg Child Behavior Inventory Problem Scale Exclusion Criteria: Severe mental health problems on Beck Depression Inventory Evidence of severe child maltreatment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Parenting Program<br>12-week group-based parenting program (Sinovuyo Caring Family Programme) delivered in weekly sessions. Program is manualized. | Behavioral: Parenting Program<br>* Goal of the program is reduction in child behavior problems in high-risk South African families. Program will be delivered to caregivers responsible for the wellbeing of the child. Program activities will be delivered over 12 weekly group sessions with additional individualized in-home sessions. The groups (n = 15 participants per group) will meet weekly with community facilitators (n = 2 per group). Parenting skills will be developed during the sessions through role-plays, group-discussion, storytelling, and home practice activities. The program is manualized in isiXhosa.<br>* Other names: Sinovuyo Caring Families Programme;|
| No Intervention: Wait-list control<br>Wait-list control group. Program delivered 3 months after posttest. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eyberg Child Behavior Inventory | This 36-item examines externalizing behavior problems in children ages 2 to 16 using both an Intensity Scale and Problem Scale. Parents are asked how often a specific behavior occurs and whether the behavior is considered a problem. Based on the most typical child behavior problems, items include has poor table manners, acts defiant when told to do something, physically fights with sisters and brothers, and fails to finish tasks or project. The Intensity Scale rates frequency of occurrence based on a 7-point Likert scale (1 = never occurs to 7 = always occurs). The Problem Scale measures whether the parent identifies a specific behavior as a problem (0 = no; 1 = yes). Both scales are summed up to create a total Intensity Score and Problem Score. Clinical cut-off scores suggested for psychopathological problem behavior are 131 for the Intensity Score and 11 for the Problem Score (Eyberg, 1999). | Change from baseline to 1 week post-program (13 weeks from baseline) | 
| Family Observation Scale, 6th Edition | The FOS-6 measures both consistency and intensity of child and parent behavior. Coding systems use a Likert scale from 0-4 to record whether and how often a particular behavior occurred (0 = behavior did not occur and/or was of low intensity; 4 = occurred a lot and/or was of high intensity). Codes are identified according to different behavioral categories through global and interval coding. Observed parent behavior includes harsh parenting, lax parenting, and praise. Similarly, child behaviors are non-compliance, proactive oppositionality, complaint, and withdrawal. Frequency and intensity scores are calculating by summing the individual scores and then dividing by the total number of observation intervals. Final scores are then calculated from means to generate an overall rating as well as for each subscale (Sanders, 2000). | Change from baseline to 1 week post-program (13 weeks from baseline) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parent-Child Conflict Tactics Scale (CTSPC) (Straus et al., 1998) | The CTSPC (27-items) contains subscales measuring psychological aggression (5-items, e.g. - shouted, yelled, or screamed at), physical assault (13-items, e.g. - hit on the bottom with a belt), and neglect (5-items, e.g. - were too drunk to take care of your child) as well as nonviolent discipline (4-items, e.g. - explained why something was wrong). Parents respond according to a Likert scale based on the number of times in the past 3 months each activity occurs (1 = never to 5 = three or more times). The CTSPC produces an overall harsh parenting score as well as for each subscale by summing the responses. It also measures the prevalence of harsh parenting by creating a dichotomized variable (0 = never, 1 = all other responses). | Change from baseline to 1 week post-program (13 weeks from baseline) | 
| Parenting Young Children Scale (PARYC) | The PARYC (14-items) measures the occurrence of specific parental behavior towards children (e.g. - notice and praise your child's good behavior) during the previous month on a 7-point Likert scale (0 = never, 7 = almost daily), as well as whether performing this behaviour is currently a problem or difficult (0 = no, 1 = yes). Items are summed to create total frequency and problem scores, as well as for each subscale. | Change from baseline to 1 week post-program (13 weeks from baseline) | 
| Parenting Stress Index-Short Form, Distress Subscale | The Parenting Distress subscale (12-items) rates parents' responses on a 5-point Likert scale regarding the frequency of stress related to parenting within the past 3 months (1 = Never; 5 = Always). Items include parenting stress due to marital conflict (e.g. - taking care of children causes problems between me and my spouse), sense of parental competence (e.g. - I feel inadequate as a parent), and lack of support (e.g. - I feel alone and without friends). Items are summed to create a total score. | Change from baseline to 1 week post-program (13 weeks from baseline) | 
| Beck Depression Inventory (BDI-II) | The BDI-II is a 21-item scale designed to assess the intensity of depression in both clinical patients and for the general population. Respondents are asked to choose from a series of statements describing various symptoms on a four-point scale (e.g. - Sadness: 0 = I do not feel sad; 1 = I feel sad much of the time; 2 = I am sad all the time; 3 = I am so sad or unhappy that I can't stand it). Responses are then summed ranging from 0 to 63, with higher scores indicating higher levels of depressive symptoms. Recommended cut-off scores are 0-13 for minimal depression, 14-19 for mild depression, 20-28 for moderate depression, and 29-63 for severe depression (Beck, 1996). | Change from baseline to 1 week post-program (13 weeks from baseline) | 
| Multidimensional Scale of Perceived Social Support (MSPSS, 12-items) | Participants report on the levels of perceived social support based on a Likert scale of 1 to 7 (1 = very strongly disagree; 1 = very strongly agree). The MSPSS includes subscales for family support (e.g. - I get the emotional support and help I need from my family), friend support (e.g. - I can count on my friends when things go wrong), and other support (e.g. - there is a special person who is around when I am in need). Responses are summed to create subscale and total scores from 12 to 84 with higher scores indicating higher levels of perceived social support. | Change from baseline to 1 week post-program (13 weeks from baseline) | 
| Parental Monitoring | 6-item subscale measuring parental monitoring from the Parenting Children and Adolescents Scale | Change from baseline to 1 week post-program (13 weeks from baseline) | 
| Empathy and Personality traits of child | Two parent-report measures will be used to assess empathy and personality traits associated with a lack of empathy in children. Using Beatty and Willis (2007) 'probing based' paradigm, cognitive interviews will be conducted with some of the parents to assess understanding and the basis of responses, while a Theory of Mind battery will be administered to assess a child's theory of mind. | Baseline | 
| Theory of mind | The UCT Theory of Mind (ToM) battery developed by Hoogenhout and Malcolm-Smith (2014) is an adaption of the battery used by Steele and colleagues (2003). The measure consists of 11 ToM tasks that are divided into four modules of increasing difficulty (Early, Basic, Intermediate, and Advanced). The Early module assesses the ability to engage in pretend play and to understand other's desires, while the Basic module includes the assessment of the classic first-order false belief task (Baron-Cohen, Leslie & Frith, 1985; Wimmer & Perner, 1983). The Intermediate and Advanced modules include second-order false belief and the child's ability to recognize faux pas, sarcasm, irony, and to distinguish between lies and jokes respectively. | Baseline | 
| Cognitive status | The Grover-Counter Scale of Cognitive Development, designed to assess cognitive functioning, was initially developed for use with handicapped subjects and specifically where verbal communication between tester and testee is compromised. This makes the test appropriate for use where tester and testee's first language differ. The scale is based on Piagetian theory and associates each stage of the test with Piaget's stages of development. Minimum achievement cut-offs are specified for each stage. Provisional norms were established based on a convenience sample of normal African-language speaking children (3-10yrs). | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Randomized Controlled Trials as Topic, Child, Parents