Child BehaviorPhase 1SCFPNCT01802294
Sinovuyo Caring Families Project - Pilot Trial
A Phase 1 study testing Parenting Program in people with Child Behavior and Parenting, run by University of Cape Town at 1 site in South Africa.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Child Behavior, Parenting, Child Abuse
- What is being tested?
- Parenting Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteSouth Africa
- Study dates
- Feb 2013to Aug 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Severe mental health problems on Beck Depression Inventory
- Evidence of severe child maltreatment
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Ikamva Labantu Wellness Centre
Cape Town, Western Cape, 7784
About this study
Official title: 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
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:
Read more
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.
- Conditions
- Child Behavior, Parenting, Child Abuse
- Being tested
- Parenting Program
- Keywords
- Randomized Controlled Trials as Topic, Child, Parents
- Medical subject headings
- Child Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parenting ProgramBehavioural
Also called Sinovuyo Caring Families Programme
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.
| Study group | Role | What they receive |
|---|---|---|
| Parenting Program | Experimental | 12-week group-based parenting program (Sinovuyo Caring Family Programme) delivered in weekly sessions. Program is manualized. Receives: Behavioral: Parenting Program |
| Wait-list control | No intervention | Wait-list control group. Program delivered 3 months after posttest. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: Change from baseline to 1 week post-program (13 weeks from baseline)
Secondary outcomes (9)
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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2013 (estimated)
- Study startFeb 2013
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cape Town
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oxford, Bangor University, Ilifa Labantwana
- Responsible party
- Principal investigator, Dr Catherine L. Ward, University of Cape Town
- Investigators
- Catherine Ward, PhD, Principal investigator, University of Cape TownLucie Cluver, DPhil, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01802294
- Sponsor's protocol ID
- Griffin39
- Acronym
- SCFP
- Status last verified
- Jun 2014
- First submitted
- 15 Feb 2013
- Last updated
- 13 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01802294
- Acronym / sponsor ID
- SCFP / Griffin39
- Conditions
- Child Behavior, Parenting, Child Abuse
- Keywords
- Randomized Controlled Trials as Topic, Child, Parents
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of Cape TownUniversity, hospital or other
- Collaborators
- University of Oxford, Bangor University, Ilifa Labantwana
- Study start
- Feb 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 1 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parenting Program | Experimental | Behavioral: Parenting Program12-week group-based parenting program (Sinovuyo Caring Family Programme) delivered in weekly sessions. Program is manualized. |
| Wait-list control | No intervention | –Wait-list control group. Program delivered 3 months after posttest. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Severe mental health problems on Beck Depression Inventory
- Evidence of severe child maltreatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parenting ProgramAlso: Sinovuyo Caring Families ProgrammeGoal 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. | Behavioural | Parenting Program |
Primary outcome
Eyberg Child Behavior Inventory
Time frame: Change from baseline to 1 week post-program (13 weeks from baseline)
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).
Family Observation Scale, 6th Edition
Time frame: Change from baseline to 1 week post-program (13 weeks from baseline)
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).
9 secondary outcomes
Parent-Child Conflict Tactics Scale (CTSPC) (Straus et al., 1998)
Time frame: Change from baseline to 1 week post-program (13 weeks from baseline)
Parenting Young Children Scale (PARYC)
Time frame: Change from baseline to 1 week post-program (13 weeks from baseline)
Parenting Stress Index-Short Form, Distress Subscale
Time frame: Change from baseline to 1 week post-program (13 weeks from baseline)
Beck Depression Inventory (BDI-II)
Time frame: Change from baseline to 1 week post-program (13 weeks from baseline)
Multidimensional Scale of Perceived Social Support (MSPSS, 12-items)
Time frame: Change from baseline to 1 week post-program (13 weeks from baseline)
Parental Monitoring
Time frame: Change from baseline to 1 week post-program (13 weeks from baseline)
Empathy and Personality traits of child
Time frame: Baseline
Theory of mind
Time frame: Baseline
Cognitive status
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine Ward, PhD principal investigator
University of Cape Town
Lucie Cluver, DPhil principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Parenting Program in people with Child Behavior and Parenting, run by University of Cape Town at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eyberg Child Behavior Inventory (time frame: Change from baseline to 1 week post-program (13 weeks from baseline)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2014.