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Randomised controlled pilot feasibility trial of an early intervention programme for young infants with neurodevelopmental impairment in Uganda: a study protocol.

ABSTRACT: INTRODUCTION:Early intervention programmes (EIPs) for infants with neurodevelopmental impairment have been poorly studied especially in low-income settings. We aim to evaluate the feasibility and acceptability of a group participatory EIP, the 'ABAaNA EIP', for young children with neurodevelopmental impairment in Uganda. METHODS AND ANALYSIS:We will conduct a pilot feasibility, single-blinded, randomised controlled trial comparing the EIP with standard care across two study sites (one urban, one rural) in central Uganda. Eligible infants (n=126, age 6-11 completed months) with neurodevelopmental impairment (defined as a developmental quotient <70 on Griffiths Scales of Mental Development, and, or Hammersmith Infant Neurological Examination score <60)?will be recruited and randomised to the intervention or standard care arm. Intervention arm families will receive the 10-modular, peer-facilitated, participatory, community-based programme over 6 months. Recruited families will be followed up at 6 and 12 months after recruitment, and assessors will be blinded to the trial allocation. The primary hypothesis is that the ABAaNA EIP is feasible and acceptable when compared with standard care. Primary outcomes of interest are feasibility (number recruited and randomised at baseline) and acceptability (protocol violation of arm allocation and number of sessions attended) and family and child quality of life. Guided by the study aim, the qualitative data analysis will use a data-led thematic framework approach. The findings will inform scalability and sustainability of the programme. ETHICS AND DISSEMINATION:The trial protocol has been approved by the relevant Ugandan and UK ethics committees. Recruited families will give written informed consent and we will follow international codes for ethics and good clinical practice. Dissemination will be through peer-reviewed publications, conference presentations and public engagement. TRIAL REGISTRATION NUMBER:ISRCTN44380971; protocol version 3.0, 19th February 2018.

SUBMITTER: Nampijja M

PROVIDER: S-EPMC6797334 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature

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Randomised controlled pilot feasibility trial of an early intervention programme for young infants with neurodevelopmental impairment in Uganda: a study protocol.

Nampijja Margaret M Webb Emily E Nanyunja Carol C Sadoo Samantha S Nalugya Ruth R Nyonyintono James J Muhumuza Anita A Ssekidde Moses M Katumba Kenneth K Magnusson Brooke B Kabugo Daniel D Cowan Frances M FM Martinez-Biarge Miriam M Zuurmond Maria M Morgan Cathy C Lester Deborah D Seeley Janet J Tann Cally J CJ

BMJ open 20191009 10

<h4>Introduction</h4>Early intervention programmes (EIPs) for infants with neurodevelopmental impairment have been poorly studied especially in low-income settings. We aim to evaluate the feasibility and acceptability of a group participatory EIP, the 'ABAaNA EIP', for young children with neurodevelopmental impairment in Uganda.<h4>Methods and analysis</h4>We will conduct a pilot feasibility, single-blinded, randomised controlled trial comparing the EIP with standard care across two study sites ...[more]

PMID: 31601606

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Project description:Feasibility studyObjectives:Refine a bespoke enhanced support intervention (ESI) (including self-help materials, intervention manual and training) for implementation by community pharmacy (CP) staff to people with sub-threshold depression and long-term conditions (LTCs) based upon evidence-supported interventions in primary careDevelop and refine study procedures (recruitment strategies and set up, screening, participant recruitment, assessment, suitability of outcome measures and data collection procedures) for testing in the pilot study phaseDesign: A case series/qualitative studySetting: UK community pharmacyPopulation: Adults with long-term health conditions who screen-positive for depression but who do not reach the threshold for DSM IV Moderate Depressive disorderIntervention: Enhanced support intervention (ESI) delivered by an appropriately trained community pharmacy team member involving four to six sessions over four months. ESI is a modified form of an intervention within the collaborative care framework for sub-threshold depression validated in previous studies in UK primary care which appears suitable for implementation in community settings.Sample size: 20-30 participantsOutcomes: Study implementation (recruitment and attrition rates), quality of data collection at baseline and 4 months and ESI adherence (number of contacts, DNA and drop out) as per objectives 1a/bQualitative evaluation: Semi-structured interviews with up to 10 participants and ESI facilitators and focus group(s) (range of pharmacy staff n =?8-10) will be conducted to explore the acceptability of the intervention and feasibility of the study, training and study procedures.External pilot studyObjectives:Quantify the flow of participants (eligibility, recruitment and follow-up rate)Evaluate proposed recruitment, assessment and outcome measure collection methodsExamine the delivery of the enhanced support intervention in a community pharmacy setting (intervention uptake, retention and dose) to inform process evaluationProcess evaluation, using semi-structured interviews with participants across a range of socio-economic settings, and pharmacy staff to explore the acceptability of the ESI within community pharmacy, elements of the intervention that were considered useful (or not) and appropriateness of study proceduresDesign: Pilot randomised controlled trial, including a prospective economic and qualitative evaluationSetting: As abovePopulation: As aboveIntervention: As above with adaptations post feasibility studyComparator: Usual careSample size: 100 participantsOutcomes: Data will be used to estimate recruitment, intervention delivery and study completion rates as per objectives 2a-d. Definitive estimates of the effectiveness of ESI will not be made.Primary outcome: Depression severity (Patient Health Questionnaire 9) at four months.Secondary outcomes: Patient acceptance, uptake and attrition. ICD10 depression status, anxiety (GAD 7), health-related quality of life (SF-12v2) and health-state utility (EQ5D 3L) will be measured at four months.Economic evaluation: The incremental cost per QALY will be calculated from both the NHS and societal perspective.Process evaluation: Using mixed methods, potential mediators/moderators of the intervention, the acceptability (to participants and pharmacy staff), barriers and facilitators to the use of ESI in community pharmacy, and impact on usual practice will be examined. Semi-structured interviews with approximately 30 study participants, 20 pharmacy staff and eight GPs near participating pharmacies will be conducted.Trial registrationISRCTN: ISRCTN11290592Protocol version number: Version 4.1 (dated 16th January 2018)Study Sponsor Tees Esk and Wear Valleys NHS Foundation Trust.

Project description:Although skin cancer is largely preventable, it affects nearly 1 of 5 US adults. There is a need for research on how to optimally design persuasive public health indoor tanning prevention messages.The objective of our study was to examine whether framed messages on indoor tanning behavioral intentions delivered through short message service (SMS) text messaging would produce (1) positive responses to the messages, including message receptivity and emotional response; (2) indoor tanning efficacy beliefs, including response efficacy and self-efficacy; and (3) indoor tanning risk beliefs.We conducted a pilot study of indoor tanning prevention messages delivered via mobile phone text messaging in a sample of 21 young adult women who indoor tan. Participants completed baseline measures, were randomly assigned to receive gain-, loss-, or balanced-framed text messages, and completed postexposure outcome measures on indoor tanning cognitions and behaviors. Participants received daily mobile phone indoor tanning prevention text messages for 1 week and completed the same postexposure measures as at baseline.Over the 1-week period there were trends or significant changes after receipt of the text messages, including increased perceived susceptibility (P<.001), response efficacy beliefs (P<.001), and message receptivity (P=.03). Ordinary least squares stepwise linear regression models showed an effect of text message exposure on self-efficacy to quit indoor tanning (t6=-2.475, P<.02). Ordinary least squares linear regression including all measured scales showed a marginal effect of SMS texts on self-efficacy (t20=1.905, P=.08). Participants endorsed highly favorable views toward the text messaging protocol.This study supports this use of mobile text messaging as an indoor tanning prevention strategy. Given the nature of skin cancer risk perceptions, the addition of multimedia messaging service is another area of potential innovation for disseminating indoor tanning prevention messages.

Project description:BackgroundYouth homelessness is a substantial issue, and many youths experiencing homelessness have mental health issues as both a cause and consequence of homelessness. These youths face many barriers to receiving traditional mental health services, and as a result, only a few youths experiencing homelessness receive any form of mental health care.ObjectiveThis project aimed to develop and determine the feasibility and acceptability of engaging young adults (ie, individuals aged 18-24 years) experiencing homelessness in a remotely delivered mental health intervention. This intervention provided brief emotional support and coping skills, drawing from cognitive behavioral principles as an introduction into psychosocial support. The intervention was piloted in a homeless shelter network.MethodsA total of 35 young adults experiencing homelessness participated in a single-arm feasibility pilot trial. Participants received a mobile phone, a service and data plan, and 1 month of support from a coach consisting of up to 3 brief phone sessions, text messaging, and mobile mental health apps. We evaluated feasibility by looking at completion of sessions as well as the overall program and acceptability with satisfaction ratings. We also collected clinical symptoms at baseline and the end of the 1-month support period. We used validity items to identify participants who might be responding inappropriately and thus only report satisfaction ratings and clinical outcomes from valid responses.ResultsMost participants (20/35, 57%) completed all 3 of their phone sessions, with an average of 2.09 sessions (SD 1.22) completed by each participant. Participants sent an average of 15.06 text messages (SD 12.62) and received an average of 19.34 messages (SD 12.70). We found higher rates of satisfaction among the participants with valid responses, with 100% (23/23) of such participants indicating that they would recommend participation to someone else and 52% (12/23) reporting that they were very or extremely satisfied with their participation. We found very little change from pre- to posttreatment on measures of depression (d=0.27), post-traumatic stress disorder (d=0.17), and emotion regulation (d=0.10).ConclusionsThis study demonstrated that it was feasible to engage homeless young adults in mental health services in this technology-based intervention with high rates of satisfaction. We did not find changes in clinical outcomes; however, we had a small sample size and a brief intervention. Technology might be an important avenue to reach young adults experiencing homelessness, but additional work could explore proper interventions to deliver with such a platform.Trial registrationClinicalTrials.gov NCT03620682; https://clinicaltrials.gov/ct2/show/NCT03620682.

Project description:Valid, reliable behavioral data and contextually meaningful interventions are necessary for improved health outcomes. Ecological Momentary Assessment and Intervention (EMAI), which collects data as behaviors occur to deliver real-time interventions, may be more accurate and reliable than retrospective methods. The rapid expansion of mobile technologies in low-and-middle-income countries allows for unprecedented remote data collection and intervention opportunities. However, no previous studies have trialed EMAI in sub-Saharan Africa. We assessed EMAI acceptability and feasibility, including participant retention and response rate, in a prospective, parallel group, randomized pilot trial in Rakai, Uganda comparing behavioral outcomes among adults submitting ecological momentary assessments (EMA) versus EMAI. After training, participants submitted EMA data on five nutrition and health risk behaviors over a 90-day period using a smartphone-based application utilizing prompt-based, participant-initiated, and geospatial coordinate data collection, with study coordinator support and incentives for >50% completion. Included behaviors and associated EMAI-arm intervention messages were selected to pilot a range of EMAI applications. Acceptability was measured on questionnaires. We estimated the association between high response rate and participant characteristics and conducted thematic analysis characterizing participant experiences. Study completion was 48/50 participants. Median prompt response rate was 66.5% (IQR: 60.0%-78.6%). Prior smartphone app use at baseline (aPR 3.76, 95%CI: 1.16-12.17, p = 0.03) and being in the intervention arm (aPR 2.55, 95% CI: 1.01-6.44, p = 0.05) were significantly associated with the top response rate quartile (response to >78.6% of prompts). All participants submitted self-initiated reports, covering all behaviors of interest, including potentially sensitive behaviors. Inconsistent phone charging was the most reported feasibility challenge. In this pilot, EMAI was acceptable and feasible. Response rates were good; additional strategies to improve compliance should be investigated. EMAI using mobile technologies may support improved behavioral data collection and intervention approaches in low and middle-income settings. This approach should be tested in larger studies.

Project description:ObjectivesDetermine the safety, feasibility and initial efficacy of a multicomponent telerehabilitation programme for COVID-19 survivors.DesignPilot randomised feasibility study.SettingIn-home telerehabilitation.Participants44 participants (21 female, mean age 52 years) discharged home following hospitalisation with COVID-19 (with and without intensive care unit (ICU) stay).InterventionsParticipants were block randomised 2:1 to receive 12 individual biobehaviourally informed, app-facilitated, multicomponent telerehabilitation sessions with a licenced physical therapist (n=29) or to a control group (n=15) consisting of education on exercise and COVID-19 recovery trajectory, physical activity and vitals monitoring, and weekly check-ins with study staff. Interventions were 100% remote and occurred over 12 weeks.Primary and secondary outcome measuresThe primary outcome was feasibility, including safety and session adherence. Secondary outcomes included preliminary efficacy outcomes including tests of function and balance; patient-reported outcome measures; a cognitive assessment; and average daily step count. The 30 s chair stand test was the main secondary (efficacy) outcome.ResultsNo adverse events (AEs) occurred during testing or in telerehabilitation sessions; 38% (11/29) of the intervention group compared with 60% (9/15) of the control group experienced an AE (p=0.21), most of which were minor, over the course of the 12-week study. 27 of 29 participants (93%; 95% CI 77% to 99%) receiving the intervention attended ≥75% of sessions. Both groups demonstrated clinically meaningful improvement in secondary outcomes with no statistically significant differences between groups.ConclusionFully remote telerehabilitation was safe, feasible, had high adherence for COVID-19 recovery, and may apply to other medically complex patients including those with barriers to access care. This pilot study was designed to evaluate feasibility; further efficacy evaluation is needed.Trial registration numberNCT04663945.

Project description:BackgroundAs suggested by the World Health Organization, breastfeeding peer support is being introduced worldwide to support women's breastfeeding needs. Evidence has shown that when such support is offered to women, the duration and exclusivity of breastfeeding is increased. We developed an innovative home-based intervention to sustain exclusive breastfeeding in Hong Kong. However, potential barriers must be addressed before a full randomised controlled trial (RCT) is conducted. The aim of this study was to determine the feasibility of a breastfeeding support programme with home-based visits from peer supporters over a six month period among postpartum Chinese women in Hong Kong.MethodsWe conducted a feasibility and pilot randomised controlled trial. Twenty primiparous women intending to breastfeed their healthy term singleton infant were recruited from a hospital in Kowloon, Hong Kong between February and March 2019. Participants were randomly allocated to the intervention or control group. Participants in the intervention group received five home-based visits with a peer supporter over a six month period, as well as standard care, whereas participants in the control group received standard care only. We assessed feasibility, compliance, and acceptability of the breastfeeding peer support programme. Other outcomes assessed were breastfeeding self-efficacy, duration, and exclusivity.ResultsIt was feasible to recruit and train existing peer supporters, and peer supporters were able to deliver the intervention, which was acceptable to women, but rates of stopping the intervention and loss to follow-up were high. There was higher retention seen within the first month. Women interviewed at the end of the study reported that the intervention was positive. The cessation risk of any, and exclusive breastfeeding were not statistically different between the intervention and control groups.ConclusionsThis study provided valuable information on feasibility of the trial design and intervention. Modifications to the intervention, such as targeting women with lower breastfeeding self-efficacy, or combining home visits with technology and telephone follow-up may be more appropriate in a larger trial. Implementing the programme early during the antenatal phase and tailoring peer support to most appropriately sustain exclusive breastfeeding and other feeding modes should be incorporated in a future home-based peer support arm.Trial registrationNCT03705494 on 15 Oct 2018.

Dataset Information

Randomised controlled pilot feasibility trial of an early intervention programme for young infants with neurodevelopmental impairment in Uganda: a study protocol.

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Randomised controlled pilot feasibility trial of an early intervention programme for young infants with neurodevelopmental impairment in Uganda: a study protocol.

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