A Family-focused Intervention Program to Foster Adolescent Mental Health and Well-being: Protocol for a Multi-country Cluster Randomized Factorial Trial (FLOURISH Phase 2)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Adolescent - Emotional Problem
- Sponsor
- University of Klagenfurt
- Enrollment
- 640
- Locations
- 1
- Primary Endpoint
- Change in levels of social support in adolescents: Medical Outcome Study Social Support Survey (MOS-SSS), "emotional support subscale", and Kidscreen-52, "peer and social support subscale"
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
The aim of this study is to conduct a multi-country, cluster-randomized factorial trial to optimize the Parenting for Lifelong Health (PLH) for Parents and Teens program in Moldova and North Macedonia. Specifically, this trial will evaluate the effectiveness and cost consequences of three additional intervention components: UNICEF's Helping Adolescents Thrive comics, adolescent peer support based on UNICEF's I Support My Friends intervention, and engagement boosters.
ALTERNATIVA will deliver the program in North Macedonia and Health for Youth Association in the Republic of Moldova.
This trial is implemented according to the Multiphase Optimization Strategy (MOST). MOST involves three phases. The preparation phase involves adapting and piloting the intervention (Phase 1). The optimization phase involves a factorial trial (Phase 2). Finally, the evaluation phase involves conducting a randomized controlled trial to assess the optimized intervention's effectiveness and cost-effectiveness (Phase 3). A Phase 2 factorial trial is the focus of this registration.
Detailed Description
Adolescent mental health is a significant global concern, especially in low- and middle-income countries (LMICs) like North Macedonia and Moldova. Adolescents in LMICs face numerous challenges, including socio-economic stressors, adverse childhood experiences, and limited access to mental health services. Parenting interventions are one approach to reduce risk for poor adolescent mental health outcomes and family maltreatment. Systematic optimization of parenting programs is essential for enhancing scalability and sustainability in low-resource settings. Building on prior research, the "Family-Focused Adolescent \& Lifelong Health Promotion" (FLOURISH) project aims to adapt, optimize, and evaluate a parenting intervention for adolescents aged 10-14 and their caregivers in North Macedonia and Moldova. The project focuses on improving adolescent mental health and well-being in both teens and caregivers, and it is implemented according to the Multiphase Optimization Strategy (MOST) framework. Phase 1 of the project assessed the feasibility of the adapted parenting intervention, which included three components to enhance participation, retention, and effectiveness. The three components were UNICEF's Helping Adolescents Thrive (HAT) comics, peer support, and engagement boosters. This protocol describes the optimization (Phase 2) of the adapted FLOURISH intervention package which will assess the effectiveness and costs of HAT, adolescent peer support, and the engagement boosters, as well as their combinations. The factorial experiment will consist of eight conditions, stratified by country, with each condition reflecting a unique combination of the three components. The results of this study will be used to select the optimized intervention package which will be tested in a randomized trial in the next phase of the FLOURISH project (Phase 3).
Investigators
Eligibility Criteria
Inclusion Criteria
- •For Caregivers:
- •Must be 18 years or older at the baseline assessment. Must be the primary caregiver of an adolescent aged 10-14 who has resided in the same household for at least four nights a week in the past month.
- •Must be able to speak at least one of the local languages in which the program will be offered (Romanian, Macedonian).
- •Must agree to participate in the program. Must provide consent for both themselves and their child to participate in the study.
- •For Adolescents:
- •Must be aged 10-14 at the baseline assessment. Must assent to participate in the study. Must have caregiver consent to participate in the study.
Exclusion Criteria
- •No formal exclusion criteria have been established for the FLOURISH project. However, during the project introduction, the research team will guide participants through a consent form that asks whether they are currently experiencing acute distress or a mental or physical health condition that could interfere with their participation. The decision will be made by the potential participant. If the participant decides they are unable to take part due to acute health issues, the research team will follow up and provide referrals to other services.
Outcomes
Primary Outcomes
Change in levels of social support in adolescents: Medical Outcome Study Social Support Survey (MOS-SSS), "emotional support subscale", and Kidscreen-52, "peer and social support subscale"
Time Frame: Pre-assessment and 6 - 8 weeks after pre-assessment
The MOS-SSS includes 18 items with a response range from 1 (none of the time) to 5 (all of the time). The emotional support scale comprises 8 items. The Kidscreen-52, peers and social support subscale, includes 6 items with a response range from 1 (never) to 5 (always). This subscale assesses the quality of the child's relationships with peers and the support they receive from their social network.
Change in levels of caregiver-reported emotional problems in adolescents: Child Behavior Checklist (CBCL) 6-18, "internalizing subscale"
Time Frame: Pre-assessment and 6 - 8 weeks after pre-assessment
The CBCL is an instrument from the Achenbach System of Empirically Based Assessment (ASEBA). Each problem item is rated 0=not true, 1=somewhat or sometimes true, and 2=very true or often true. Standardized scores can be computed with higher scores indicating more problems.
Change in levels of family functioning in caregivers: Family Assessment Device (FAD), subscale "general functioning"
Time Frame: Pre-assessment and 6 - 8 weeks after pre-assessment
The general functioning subscale is one of the dimensions of the FAD and will be completed by caregivers. This scale has also been used as a single indicator to assess family functioning. The general functioning scale is made up of 12 items with six items that reflect healthy family functioning and the other six items reflecting unhealthy functioning. Scoring is on a 4-point scale (from 1 for strongly agree to 4 for strongly disagree) with the scoring for the negatively worded items reversed.
Attendance rate
Time Frame: During the implementation of the intervention (6 - 8 weeks)
Attendance will be assessed as the percentage of group PLH sessions attended out of 6 (individual attendance for adolescents and caregivers)
Secondary Outcomes
- Change in levels of psychological distress in caregivers: Patient Health Questionnaire - 9 (PHQ-9), total score(Pre-Post (approximately 6 - 8 weeks after pre-assessment))
- Change in levels of emotional problems in adolescents: Revised Child Anxiety and Depression Scales (RCADS), total score, "depression and anxiety subscales"(Pre-Post (approximately 6 - 8 weeks after pre-assessment))
- Change in levels of family communication in adolescents: Child-Parent Communication Apprehension scale (CPA-YA), total score(Pre-assessment and 6 - 8 weeks after pre-assessment)
- Change in levels of loneliness in adolescents: UCLA-8 Loneliness scale, total score(Pre-Post (approximately 6 - 8 weeks after pre-assessment))
- Change in levels of well-being in adolescents and caregivers: World Health Organization-Five Well-Being Index (WHO-5), total score(Pre-Post (approximately 6 - 8 weeks after pre-assessment))
- Change in levels of emotional problems in adolescents: Pediatric Symptom Checklist (PSC), adolescent and caregiver report, total score, "internalizing, externalizing and attention subscales"(Pre-assessment and 6 - 8 weeks after pre-assessment)
- Change in levels of caregiver-reported behavior problems in adolescents: Child Behavior Checklist (CBCL) 6-18, parent-report, subscales "rule-breaking and aggressive behavior, externalizing behavior"(Pre-assessment and 6 - 8 weeks after pre-assessment)
- Change in levels of family functioning in caregivers: Family Assessment Device (FAD), "problem solving and communication subscales"(Pre-assessment and 6 - 8 weeks after pre-assessment)
- Change in adolescent socio-emotional skills: Social Emotional Abilities and Learning (SEAL) Tool, "emotional regulation, stress management, problem-solving, interpersonal skills, and self-esteem subscales"(Pre-assessment and 6 - 8 weeks after pre-assessment)
- Change in levels of parental stress in caregivers: Parental Stress Scale (PSS), total score(Pre-Post (approximately 6 - 8 weeks after pre-assessment))
- Change in levels of loneliness in caregivers: Revised UCLA Loneliness scale (RULS-6), total score(Pre-Post (approximately 6 - 8 weeks after pre-assessment))
- Change in caregiver capabilities: Oxford CAPabilities questionnaire - Mental Health (OxCAP-MH)(Pre-assessment and 6 - 8 weeks after pre-assessment)
- Change in frequency of parenting practices: Alabama Parenting Questionnaire-APQ, subscale "involved parenting" and "positive parenting" (parent- and child-report), and subscale "corporal punishment" (parent-report)(Pre-Post (approximately 6 - 8 weeks after pre-assessment))
- Change in levels of social support in adolescents: Medical Outcome Study Social Support Survey (MOS-SSS), "affectionate subscale"(Pre-Post (approximately 6 - 8 weeks after pre-assessment))
- Change in levels of social support in caregivers: Medical Outcome Study Social Support Survey (MOS-SSS), "emotional and affectionate subscales"(Pre-assessment and 6 - 8 weeks after pre-assessment)
- Change in adolescent health-related quality of life: EQ-5D-Y-3L(Pre-assessment and 6 - 8 weeks after pre-assessment)
- Change in caregiver health-related quality of life: EQ-5D-5L(Pre-assessment and 6 - 8 weeks after pre-assessment)
- Change in caregiver resource use: PECUNIA Resource Use Measurement (PECUNIA RUM)(Pre-assessment and 6 - 8 weeks after pre-assessment)
- Change in caregiver-reported resource use in adolescents: PECUNIA Resource Use Measurement (PECUNIA RUM) proxy for adolescents(Pre-assessment and 6 - 8 weeks after pre-assessment)