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Family-based promotion of mental health in children affected by HIV: a pilot randomized controlled trial.

ABSTRACT: Children affected by HIV are at risk for poor mental health. We conducted a pilot randomized controlled trial (RCT) of the Family Strengthening Intervention (FSI-HIV), a family home-visiting intervention to promote mental health and improve parent-child relationships in families with caregivers living with HIV, hypothesizing that child and family outcomes would be superior to usual care social work services.Eighty two families (N = 170 children, 48.24% female; N = 123 caregivers, 68.29% female) with at least one HIV-positive caregiver (n = 103, 83.74%) and school-aged child (ages 7-17) (HIV+ n = 21, 12.35%) were randomized to receive FSI-HIV or treatment-as-usual (TAU). Local research assistants blind to treatment conducted assessments of child mental health, parenting practices, and family functioning at baseline, post-intervention, and 3-month follow-up. Multilevel modeling assessed effects of FSI-HIV on outcomes across three time points.NCT01509573, 'Pilot Feasibility Trial of the Family Strengthening Intervention in Rwanda (FSI-HIV-R).' https://clinicaltrials.gov/ct2/show/;NCT01509573?term=Pilot+Feasibility+Trial+of+the+Family+Strengthening+Intervention+in+Rwanda+%28FSI-HIV-R%29&rank=1.At 3-month follow-up, children in FSI-HIV showed fewer symptoms of depression compared to TAU by both self-report (? = -.246; p = .009) and parent report (? = -.174; p = .035) but there were no significant differences by group on conduct problems, functional impairment, family connectedness, or parenting.Family-based prevention has promise for reducing depression symptoms in children affected by HIV. Future trials should examine the effects of FSI-HIV over time in trials powered to examine treatment mediators.

SUBMITTER: Betancourt TS

PROVIDER: S-EPMC5730278 | biostudies-literature | 2017 Aug

REPOSITORIES: biostudies-literature

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Family-based promotion of mental health in children affected by HIV: a pilot randomized controlled trial.

Betancourt Theresa S TS Ng Lauren C LC Kirk Catherine M CM Brennan Robert T RT Beardslee William R WR Stulac Sara S Mushashi Christine C Nduwimana Estella E Mukunzi Sylvere S Nyirandagijimana Beatha B Kalisa Godfrey G Rwabukwisi Cyamatare F CF Sezibera Vincent V

Journal of child psychology and psychiatry, and allied disciplines 20170515 8

<h4>Background</h4>Children affected by HIV are at risk for poor mental health. We conducted a pilot randomized controlled trial (RCT) of the Family Strengthening Intervention (FSI-HIV), a family home-visiting intervention to promote mental health and improve parent-child relationships in families with caregivers living with HIV, hypothesizing that child and family outcomes would be superior to usual care social work services.<h4>Methods</h4>Eighty two families (N = 170 children, 48.24% female; ...[more]

PMID: 28504307

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Project description:BACKGROUND:High positive mental health, including the ability to cope with the normal stresses of life, work productively, and be able to contribute to one's community, has been associated with various health outcomes. The role of positive mental health is therefore increasingly recognized in national mental health promotion programs and policies. Mobile health (mHealth) interventions could be a cost-effective way to disseminate positive psychological interventions to the general population. OBJECTIVE:The aim of this study was to estimate the effect of a fully automated mHealth intervention on positive mental health, and anxiety and depression symptomology among Swedish university students using a randomized controlled trial design. METHODS:A 2-arm, single-blind (researchers), parallel-groups randomized controlled trial with an mHealth positive psychology program intervention group and a relevant online mental health information control group was employed to estimate the effect of the novel intervention. Participants were recruited using digital advertising through student health care centers in Sweden. Inclusion criteria were (1) university students, (2) able to read and understand Swedish, (3) and have access to a mobile phone. Exclusion criteria were high positive mental health, as assessed by the Mental Health Continuum Short Form (MHC-SF), or high depression and anxiety symptomology, as assessed by the Hospital Anxiety Depression Scale (HADS). The primary outcome was positive mental health (MHC-SF), and the secondary outcomes were depression and anxiety symptomatology (HADS). The subscales of MHC-SF were also analyzed as exploratory outcomes. Outcomes were measured 3 months after randomization through questionnaires completed on the participants' mobile phones. RESULTS:A total of 654 participants (median age 25 years), including 510 (78.0%) identifying as female, were randomized to either the intervention (n=348) or control group (n=306). At follow-up, positive mental health was significantly higher in the intervention group compared with the control group (incidence rate ratio [IRR]=1.067, 95% CI 1.024-1.112, P=.002). For both depression and anxiety symptomatology, the intervention group showed significantly lower scores at follow-up compared with the control group (depression: IRR=0.820, 95% CI 0.714-0.942, P=.005; anxiety: IRR=0.899, 95% CI 0.840-0.962, P=.002). Follow-up rates were lower than expected (58.3% for primary outcomes and 52.3% for secondary outcomes); however, attrition analyses did not identify any systematic attrition with respect to baseline variables. CONCLUSIONS:The mHealth intervention was estimated to be superior to usual care in increasing positive mental health among university students. A protective effect of the intervention was also found on depressive and anxiety symptoms. These findings demonstrate the feasibility of using an automated mobile phone format to enhance positive mental health, which offers promise for the use of mHealth solutions in public mental health promotion. TRIAL REGISTRATION:International Standard Randomized Controlled Trial Registry ISRCTN54748632; http://www.isrctn.com/ISRCTN54748632.

Project description:BackgroundThere is an urgent need for efficacious interventions to combat the global mental health crisis, and mental health promotion and primary prevention approaches are paramount. The aim of this study is to examine whether an online interdisciplinary intervention that incorporates evidence-based strategies from the disciplines of Lifestyle Medicine and Positive Psychology improves measures of mental health and emotional wellness.MethodsA randomized controlled trial with a wait-list control (N = 425, aged 46.97 ± 14.5, 69.9% females) was conducted in Australia and New Zealand. The intervention group participated in a 10-week online interdisciplinary intervention. Primary outcome measures of mental health and emotional wellness were taken at baseline (Week 1), post-intervention (Week 12), and 12 weeks post-intervention (Week 24). The wait-list control completed the same assessments.ResultsGeneral Linear Modelling analyses indicated that the intervention group experienced significantly greater improvements than the wait-list control group over time in all outcome measures: mental health (F(319) = 7.326, p = 0.007) and vitality (F(319) = 9.445, p = 0.002) subscales of the Short Form Survey (SF-36); depression (F(319) = 7.841, p = 0.005), anxiety (F(319) = 4.440, p = 0.36) and stress (F(319) = 12.494, p < 0.001) scales of the Depression, Anxiety and Stress Scale (DASS-21); and life satisfaction (F(319) = 8.731, p = 0.003) as measured by the Satisfaction With Life Scale. Within the intervention group, significant improvements were observed from Week 1 to 12 in all outcome measures: mental health (10%, t(167) = - 6.423), p < 0.001, dz = 0.50), vitality (22%, t(167) = - 7.043, p < 0.001, dz = 0.54), depression (- 41%, t(167) = 6.189, p < 0.001, dz = 0.48), anxiety (- 38%, t(167) = 5.030, p < 0.001, dz = 0.39), stress (- 31%, t(167) = 6.702, p < 0.001, dz = 0.52) and life satisfaction (8%, t(167) = - 6.199, p < 0.001, dz = 0.48). Improvements in the outcome measures remained significant in the intervention group at 12 weeks post-intervention.ConclusionThe online interdisciplinary intervention improved measures of mental health and emotional wellness suggesting that such interventions may be useful for mental health promotion and prevention. Trial registration The Australian New Zealand Clinical Trials Registry. ACTRN12619000993190. Registered on 12 July 2019 (Retrospectively registered). The ANZCTRN is part of the WHO Primary Registries.

Project description:This study aims to intensively evaluate the effectiveness of mindfulness-based intervention (MBI) on mental illness risks (including psychological distress, prolonged fatigue, and perceived stress) and job strain (job control and job demands) for employees with poor mental health.A longitudinal research design was adopted. In total, 144 participants were randomized to the intervention group or the control group. The intervention group participated in MBI for eight weeks. Measurements were collected for both groups at five time points: at pre-intervention (T1), at mid-intervention (T2), at the completion of intervention (T3), four weeks after intervention (T4), and eight weeks after intervention (T5). Data were analyzed according to the intention-to-treat principle. A linear mixed model with two levels was employed to analyze the repeated measurement data.Compared with the control group, the intercepts (means at T3) for the intervention group were significantly lower on psychological distress, prolonged fatigue, and perceived stress when MBI was completed. Even with the demographic variables controlled, the positive effects remained. For growth rates of prolonged fatigue and perceived stress, participants in the intervention group showed a steeper decrease than did the participants in the control group. Regarding job strain, although the intercept (mean at T3) of job demands showed a significant decline when BMI was completed, the significance disappeared when the demographic variables were controlled. Moreover, the other results for job control and job demands did not show promising findings.As a workplace health promotion program, the MBI seems to have potential in improving mental illness risks for employees with poor mental health. However, there was insufficient evidence to support its effect on mitigating job strain. Further research on maintaining the positive effects on mental health for the long term and on developing innovative MBI to suit job strain are recommended.ClinicalTrials.gov NCT02241070.

Project description:BackgroundThe COordinated Oral health Promotion (CO-OP) Chicago trial will test the efficacy of a community health worker (CHW) intervention to improve oral health behaviors for children at high risk for early childhood caries. Before implementing the cluster-randomized controlled trial, we conducted a formative assessment to determine the final design. We used qualitative methods to assess the feasibility and acceptability of the proposed recruitment, data collection, and intervention plan.MethodsKey informant interviews (N = 37) and site observations were conducted at 10 pediatric primary care clinics and 10 Special Supplemental Nutrition Program for Women Infant and Children (WIC) centers to gain insight from providers and administrators at the locations where recruitment and intervention will occur. Eight focus groups (N = 68) were conducted with caregivers of children to capture the parent perspective. Conceptual coding methods from grounded theory were applied to organize the data into the final themes.ResultsFamilies, clinics, and WIC centers were all very interested in additional supports for oral health and were enthusiastic about CHWs. Challenges included competing family priorities that might interfere in study enrollment and intervention efficacy. Physical space for enrollment and intervention delivery was a major barrier for some sites. Home visits for data collection and intervention delivery would be unacceptable for some families. These challenges and barriers prompted us to make major changes in our trial design. We opened the option for data collection to occur in multiple locations. We eliminated the home-only arm of the trial. Clinics and WIC centers that are randomized to the non-intervention arm will now have CHWs available at the study conclusion. Finally, we aligned the CHW oral health topics to the needs of families.ConclusionsWe conducted this comprehensive formative assessment to determine the feasibility and acceptability of the CO-OP Chicago trial. While overall acceptance of the trial was high, the results highlighted specific issues with the proposed trial implementation plan and led to several critical design changes. This type of formative work requires a significant upfront investment but we expect it will translate into savings through better recruitment, retention, intervention implementation and adherence, and result dissemination.

Project description:IntroductionFamily-based physical activity (PA) interventions present a promising avenue to promote children's activity; however, high-quality experimental research is lacking. This paper describes the protocol for the FRESH (Families Reporting Every Step to Health) pilot trial, a child-led family-based PA intervention delivered online.Methods and analysisFRESH is a three-armed, parallel-group, randomised controlled pilot trial using a 1:1:1 allocation ratio with follow-up assessments at 8 and 52 weeks postbaseline. Families will be eligible if a minimum of one child in school Years 3-6 (aged 7-11 years) and at least one adult responsible for that child are willing to participate. Family members can take part in the intervention irrespective of their participation in the accompanying evaluation and vice versa.Following baseline assessment, families will be randomly allocated to one of three arms: (1) FRESH; (2) pedometer-only or (3) no-intervention control. All family members in the pedometer-only and FRESH arms receive pedometers and generic PA promotion information. FRESH families additionally receive access to the intervention website; allowing participants to select step challenges to 'travel' to target cities around the world, log steps and track progress as they virtually globetrot. Control families will receive no treatment. All family members will be eligible to participate in the evaluation with two follow-ups (8 and 52 weeks). Physical (eg, fitness and blood pressure), psychosocial (eg, social support) and behavioural (eg, objectively measured family PA) measures will be collected at each time point. At 8-week follow-up, a mixed methods process evaluation will be conducted (questionnaires and family focus groups) assessing acceptability of the intervention and evaluation. FRESH families' website engagement will also be explored.Ethics and disseminationThis study received ethical approval from the Ethics Committee for the School of the Humanities and Social Sciences at the University of Cambridge. Findings will be disseminated via peer-reviewed publications, conferences and to participating families.Trial registration numberISRCTN12789422.

Project description:OBJECTIVE:Early childhood development programs typically combine healthy nutrition and cognitive stimulation in an integrated model. We separately delivered these 2 components in a cluster-randomized controlled trial to evaluate their comparative effectiveness in promoting healthy child development and caregiver mental health. This is the first study to do so for HIV-affected children and their infected mothers. METHODS:Two hundred twenty-one HIV-exposed but uninfected child (2-3 years old) and caregiver dyads in 18 geographic clusters in Eastern Uganda were randomized by cluster to receive biweekly individualized sessions of either (1) Mediational Intervention for Sensitizing Caregivers (MISC) training emphasizing cognitive stimulation or (2) Uganda Community Based Association for Child Welfare (UCOBAC) program that delivered health and nutrition training. Children were evaluated at baseline, 6 months, 1 year (training conclusion), and 1-year posttraining with the Mullen Scales of Early Learning (MSEL), the Color-Object Association Test for memory, the Early Childhood Vigilance Test of attention, and the Behavior Rating Inventory of Executive Function (BRIEF-parent). The Caldwell Home Observation for the Measurement of the Environment (HOME) was completed by observers to gauge caregiving quality after training. Caregiver depression/anxiety (Hopkins Symptom Checklist-25) and functionality (list of activities of daily living) were also evaluated. Data collectors were blinded to trial arm assignment. RESULTS:Mediational Intervention for Sensitizing Caregivers resulted in significantly better quality of caregiving compared with UCOBAC midintervention with an adjusted mean difference (MadjDiff) of 2.34 (95% confidence interval [CI]: 1.54-3.15, p < .01), postintervention (MadjDiff = 2.43, 95% CI: 1.61-3.25, p < .01), and at 1-year follow-up (MadjDiff = 2.07, 95% CI: 1.23-2.90, p < .01). MISC caregivers reported more problems on the BRIEF for their child at 1-year posttraining only (p < .01). Caregiving quality (HOME) was significantly correlated with MSEL composite performance 1-year posttraining for both the MISC and the UCOBAC trial arms. Likewise, physical growth was significantly related to child development outcomes even though it did not differ between trial arms. CONCLUSION:Even though MISC demonstrated an advantage of improving caregiving quality, it did not produce better child cognitive outcomes compared with health and nutrition training. TRIAL REGISTRATION:clinicaltrials.gov Identifier: NCT01640561.

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Family-based promotion of mental health in children affected by HIV: a pilot randomized controlled trial.

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Family-based promotion of mental health in children affected by HIV: a pilot randomized controlled trial.

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