Dataset Information

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

ABSTRACT:

Background

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.

Methods

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.

Trial registration

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.

Results

At 3-month follow-up, children in FSI-HIV showed fewer symptoms of depression compared to TAU by both self-report (β = -.246; p = .009) and parent report (β = -.174; p = .035) but there were no significant differences by group on conduct problems, functional impairment, family connectedness, or parenting.

Conclusions

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

ACCESS DATA

Publications

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

Similar Datasets

Project description:Few randomized controlled trials (RCTs) report interventions targeting improvement of frailty status as an outcome.This RCT enrolled 117 older adults (65-79?years of age) in Toufen, Taiwan who scored 3-6 on The Chinese Canadian Study of Health and Aging Clinical Frailty Scale Telephone Version and then score ?1 on the Cardiovascular Health Study Phenotypic Classification of Frailty (CHS_PCF). With a two by two factorial design, subjects were randomly assigned to interventions (Exercise and nutrition, EN, n?=?55 or problem solving therapy, PST, n?=?57) or controls (non-EN, n?=?62 or non-PST, n?=?60). Educational booklets were provided to all. EN group subjects received nutrition consultation and a thrice-weekly exercise-training program while PST group subjects received 6 sessions in 3?month. Subjects were followed at 3, 6, and 12?months. Primary outcome was improvement of the CHS_PCF by at least one category (from pre-frail to robust, or from frail to pre-frail or robust) from baseline assessments. One hundred and one completed final assessments. Intention-to-treat analysis with the generalized estimating equation model was applied with adjustment for time and treatment-by-time interactions.Mean age was 71.4?±?3.7?years, with 59% females. Baseline characteristic were generally comparable between groups. EN group subjects had a higher improvement rate on the primary outcome than non-EN group subjects (45% vs 27%, adjusted p?=?0.008) at 3?months, but not 6 or 12?months. They also had more increase of serum 25(OH) vitamin D level (4.9?±?7.7 vs 1.2?±?5.4, p?=?0.006) and lower percentage of osteopenia (74% vs 89% p?=?0.042) at 12?months. PST group subjects had better improvement (2.7?±?6.1 vs 0.2?±?6.7, p?=?0.035, 6-month) and less deterioration (-3.5?±?9.7 vs -7.1?±?8.7, p?=?0.036, 12-month) of dominant leg extension power than non-PST subjects. Some secondary outcomes were also improved in control groups (non-EN or non-PST). No adverse effects were reported.The three-month EN intervention resulted in short-term (3-month) frailty status improvement and long-term effect on bone mineral density and serum vitamin D (12-month) among Taiwanese community-dwelling elders. The effect of PST was less pronounced.ClinicalTrials.gov: EC0970301

Project description:BackgroundHigh 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.ObjectiveThe 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.MethodsA 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.ResultsA 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.ConclusionsThe 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 registrationInternational Standard Randomized Controlled Trial Registry ISRCTN54748632; http://www.isrctn.com/ISRCTN54748632.

Project description:BackgroundPosttraumatic stress disorder (PTSD) among US military veterans can adversely impact their concerned significant others (CSOs; eg, family members and romantic partners). Mobile apps can be tailored to support CSO mental health through psychoeducation, coping skills, and stress monitoring.ObjectiveThis study assessed the feasibility, acceptability, and potential efficacy of PTSD Family Coach 1.0, a free, publicly available app that includes psychoeducation, stress management tools, self-assessments, and features for connecting to alternative supports, compared with a psychoeducation-only version of the app for cohabitating CSOs of veterans with PTSD.MethodsA total of 200 participants with an average age of 39 (SD 8.44) years, primarily female (193/200, 97%), and White (160/200, 80%) were randomized to self-guided use of either PTSD Family Coach 1.0 (n=104) or a psychoeducation-only app (n=96) for 4 weeks. Caregiver burden, stress, depression, anxiety, beliefs about treatment, CSO self-efficacy, and relationship functioning assessed using measures of dyadic adjustment, social constraints, and communication danger signs were administered via a web survey at baseline and after treatment. User satisfaction and app helpfulness were assessed after treatment. Data were analyzed using linear mixed methods.ResultsOverall, 50.5% (101/200) of randomized participants used their allocated app. Participants found PTSD Family Coach 1.0 somewhat satisfying (mean 4.88, SD 1.11) and moderately helpful (mean 2.99, SD 0.97) to use. Linear mixed effects models revealed no significant differences in outcomes by condition for caregiver burden (P=.45; Cohen d=0.1, 95% CI -0.2 to 0.4), stress (P=.64; Cohen d=0.1, 95% CI -0.4 to 0.6), depression (P=.93; Cohen d= 0.0, 95% CI -0.3 to 0.3), anxiety (P=.55; Cohen d=-0.1, 95% CI -0.4 to 0.2), beliefs about treatment (P=.71; Cohen d=0.1, 95% CI -0.2 to 0.3), partner self-efficacy (P=.59; Cohen d=-0.1, 95% CI -0.4 to 0.2), dyadic adjustment (P=.08; Cohen d=-0.2, 95% CI -0.5 to 0.0), social constraints (P=.05; Cohen d=0.3, 95% CI 0.0-0.6), or communication danger signs (P=.90; Cohen d=-0.0, 95% CI -0.3 to 0.3). Post hoc analyses collapsing across conditions revealed a significant between-group effect on stress for app users versus nonusers (β=-3.62; t281=-2.27; P=.02).ConclusionsApproximately half of the randomized participants never used their allocated app, and participants in the PTSD Family Coach 1.0 condition only opened the app approximately 4 times over 4 weeks, suggesting limitations to this app version's feasibility. PTSD Family Coach 1.0 users reported moderately favorable impressions of the app, suggesting preliminary acceptability. Regarding efficacy, no significant difference was found between PTSD Family Coach 1.0 users and psychoeducation app users across any outcome of interest. Post hoc analyses suggested that app use regardless of treatment condition was associated with reduced stress. Further research that improves app feasibility and establishes efficacy in targeting the domains most relevant to CSOs is warranted.Trial registrationClinicalTrials.gov NCT02486705; https://clinicaltrials.gov/ct2/show/NCT02486705.

Project description:BackgroundBlack women bear a disproportionate burden of HIV, accounting for nearly 60% of new diagnoses among US women. Black women living with HIV often experience mutually reinforcing epidemics, known as syndemics, including interpersonal violence and substance use. Syndemics are associated with decreased HIV care engagement and treatment adherence and worsening HIV outcomes. Few HIV services and resources are tailored to be culturally and gender-responsive and trauma informed for Black women living with HIV. Technology-based, psychoeducational, and peer navigation programs offer promising pathways to tailored HIV support and improved HIV care outcomes. Therefore, the web-based, trauma-informed intervention LinkPositively was developed in collaboration with Black women living with HIV to promote uptake of HIV care and ancillary support services.ObjectiveThis study primarily determines the feasibility and acceptability of the LinkPositively intervention among Black women living with HIV affected by interpersonal violence. The secondary aim is to examine the preliminary impact of the LinkPositively intervention on retention in HIV care, antiretroviral therapy adherence, and viral suppression while evaluating the role of mechanism of change variables (eg, social support) in the associations.MethodsThe LinkPositively trial is a pilot randomized controlled trial conducted in California, United States, among 80 adult Black women living with HIV who have experienced interpersonal violence. Core components of LinkPositively include one-on-one peer navigation with phone and SMS text message check-ins; 5 weekly one-on-one video sessions to build coping and care navigation skills; and a mobile app that contains a peer support social networking platform, an educational database with healthy living and self-care tips, a GPS-enabled HIV and ancillary care resource locator, and a medication self-monitoring and reminder system. Participants are randomly assigned to the intervention (n=40) or control (Ryan White standard of care; n=40) arm, with follow-up at 3 and 6 months. At each assessment, participants complete an interviewer-administered survey and submit hair samples for the assessment of HIV medication adherence. All research staff and investigators adhere to ethical principles and guidelines for conducting research activities. Data will be analyzed using generalized estimating equations.ResultsFinal development and testing of the LinkPositively app were completed in July 2021. As of May 2023, we have screened 97 women for eligibility. Of the 97 women screened, 27 (28%) were eligible and have been enrolled in the study. The dissemination of preliminary results will occur in 2024.ConclusionsThis trial will advance HIV prevention science by harnessing technology to promote engagement in HIV care while improving social support through peers and social networking-all while being trauma informed for Black women living with HIV with experiences of interpersonal violence. If shown to be feasible and acceptable, LinkPositively has the potential to improve HIV care outcomes among Black women, a marginalized key population.International registered report identifier (irrid)DERR1-10.2196/46325.

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.

Dataset Information

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

Background

Methods

Trial registration

Results

Conclusions

Publications

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

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets