Randomized Controlled Trial of a Family-focused Intervention for Caregivers and Young Adolescents (Phase 3 of FLOURISH)

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 evaluation 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 and cultural adaptation of the PLH for Parents and Teens program. In Phase 2, a multi-country factorial trial tested different combinations of three additional components (adolescent mental health tools from UNICEF's Helping Adolescents Thrive comics, adolescent peer support, and engagement boosters) and identified the optimized intervention package.

This protocol describes the evaluation (Phase 3) of the optimized FLOURISH intervention package. The randomized waitlist controlled trial will recruit adolescent-caregiver pairs (320 to 340 families per country, 640 to 660 total) to test the effectiveness, cost-effectiveness, and scalability of the optimized PLH program. Families assigned to the intervention group will receive the program over seven weeks (one pre-program visit and six weekly group sessions), while families in the waitlist control group will receive the intervention after the six-month follow-up assessment. The results of this study will inform the potential for scaling up the optimized intervention at the national level in both countries and contribute robust evidence on adolescent mental health promotion in LMICs.

A first version of this ClinicalTrials.gov record was completed in the PRS system on October 3, 2025, prior to participant recruitment. Due to disruptions related to the U.S. government shutdown affecting ClinicalTrials.gov processing during October/November 2025, there was a delay in public release of the record. Participant recruitment began on October 24, 2025.

• Change in levels of family communication in adolescents: Child-Parent Communication Apprehension scale (CPA-YA), total score [Time frame: Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up]
• Change in levels of loneliness in adolescents: UCLA-8 Loneliness scale, total score [Time frame: Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up]
• Change in frequency of parenting practices (adolescent-report): Alabama Parenting Questionnaire (APQ), subscales involved and positive parenting [Time frame: Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up]
• Change in levels of emotional and behavioral problems in adolescents (adolescent-report): Pediatric Symptom Checklist (PSC-17), internalizing, externalizing and attention subscales, total score [Time frame: Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up]
• Change in levels of well-being in adolescents: World Health Organization-Five Well-Being Index (WHO-5), total score [Time frame: Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up]
• Change in levels of emotional problems in adolescents: Revised Child Anxiety and Depression Scale (RCADS), depression and anxiety subscales, total score [Time frame: Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up]
• Change in adolescent socio-emotional skills: Social Emotional Abilities and Learning (SEAL) Tool, subscales emotional regulation, problem-solving, interpersonal skills [Time frame: Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up]
• Change in levels of bullying involvement in adolescents: Health Behaviour in School-aged Children (HBSC), peer violence subscale [Time frame: Pre-assessment and 6-month follow-up]
• Change in levels of parent-child communication in adolescents: Parent-Child Communication scale [Time frame: Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up]
• Change in levels of social support in adolescents: Medical Outcome Study Social Support Survey (MOS-SSS), emotional and affectionate subscales [Time frame: Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up]
• Change in frequency of parenting practices in caregivers: Alabama Parenting Questionnaire (APQ), subscale corporal punishment [Time frame: Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up]
• Change in frequency of emotionally maltreating behaviors in caregivers: International Child Abuse Screening Tool (ICAST), emotional maltreatment subscale [Time frame: Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up]