Testing a programme to support the emotional and behavioural wellbeing of children aged 5–10 years in Albania

ISRCTN	ISRCTN66706005
DOI	https://doi.org/10.1186/ISRCTN66706005
Sponsor	Terre des Hommes
Funder	IF! Foundation

Submission date: 09/11/2026
Registration date: 10/11/2026
Last edited: 10/11/2026

Recruitment status: Not yet recruiting
Overall study status: Ongoing
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mrs Ilva Vjero
Public

Rruga Skënderbej, Nd. 6, H. 2, Ap. 17–18
Tirana
1000
Albania

Phone	+355 (0)692122989
Email	ilva.vjero@tdh.org

Dr Sarah Skeen
Scientific

Education Building, Francie van Zijl Drive, Tygerberg
Cape Town
7505
South Africa

Phone	+27 (0)21 938 9043
Email	skeens@who.int

Dr Felicity Brown
Principal investigator

United Nations Ave, Gigiri | Nairobi, Kenya
(working remotely in France, GMT+1)
Paris
75001
France

Phone	+254 (0)207621234
Email	febrown@unicef.org

Mrs Ilva Vjero
Principal investigator

Rruga Skënderbej, Nd. 6, H. 2, Ap. 17–18
Tirana
1000
Albania

Phone	+355 (0)692122989
Email	ilva.vjero@tdh.org

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Blinded (masking used)
Control	Active
Assignment	Parallel
Purpose	Treatment
Scientific title	A feasibility randomized controlled trial of the BLOOM intervention for children aged 5–10 years in Albania
Study objectives
Ethics approval(s)	Submitted 29/09/2026, Research Ethics - Faculty of Social Sciences, University of Tirana (Bulevardi "Gjergj Fishta", Tirana, 1000, Albania; +355 (0)4 222 8402; fshs.ut.info@unitir.edu.al), ref: Not yet assigned
Health condition(s) or problem(s) studied	Emotional and behavioural difficulties in children aged 5–10 years, including difficulties with emotional regulation, managing behaviour, relationships and interactions with caregivers, and psychosocial wellbeing
Intervention	Eligible children and their parents or primary caregivers will be enrolled in the study following screening, eligibility assessment and informed consent. 60-80 families will be recruited from selected community-based services in Tirana and Kukës, Albania. A sample size of minimum 60 participants was determined to be sufficient to answer the feasibility trial research questions. Based on the identification, recruitment, and screening process, we expect at least 60 families to be enrolled, but this number may increase to maximum of 80 families taking part in BLOOM, depending on eligibility rates and baseline completion rates. Participants will be individually randomised within each municipality (Tirana and Kukës) using a 1:1 allocation ratio. The randomisation sequence will be computer-generated by the University of Tirana, with separate allocation sequences for each municipality. Randomisation will take place after completion of baseline assessments. The research team will securely maintain the allocation information and communicate group assignments to the intervention providers. Providers cannot be blinded to group allocation as they are responsible for delivering the intervention. Data collectors (outcome assessors) will remain blinded to participants' group allocation throughout outcome data collection, wherever possible. Any accidental unblinding will be documented. 1. Intervention group (BLOOM): Families will receive the BLOOM intervention, a structured psychosocial programme designed to support children's emotional and behavioural wellbeing and strengthen positive parenting and caregiver-child interactions. The intervention will be delivered by trained non-specialist providers to children aged 5–10 years and their parents or primary caregivers. It will consist of nine sessions, each lasting approximately 60 minutes, delivered over a period of approximately 2–3 months. Sessions will cover topics including parenting skills, emotional regulation, positive behaviour support, problem-solving and strengthening caregiver-child relationships. The programme will also include referrals to specialised services when needed. 2. Control group (care as usual): Families allocated to the control group will continue to receive the usual services and support available through community-based services and other relevant local providers. They will not receive the BLOOM intervention during the initial comparison period. Following completion of the post-intervention assessment, families in this group will also be offered the BLOOM programme. Data will be collected at baseline and endline. Child and caregiver outcomes will be assessed using standardised questionnaires, including the Paediatric Symptom Checklist (PSC-35), Kiddy-KINDL, the Behaviour and Feelings Survey, the Brief Parenting Scale and the Kessler Psychological Distress Scale (K6). Assessments will be conducted by trained assessors who will be masked to group allocation. The study will assess the feasibility and acceptability of delivering the BLOOM intervention in the Albanian context, as well as changes in children's emotional and behavioural difficulties, psychosocial wellbeing and parenting-related outcomes.
Intervention type	Behavioural
Primary outcome measure(s)	Emotional and behavioural difficulties measured using the caregiver-reported Pediatric Symptom Checklist (PSC-35) total score at 12 weeks after baseline assessment (endline)
Key secondary outcome measure(s)
Completion date	30/09/2027

Eligibility

Participant type(s)
Age group	Child
Lower age limit	5 Years
Upper age limit	10 Years
Sex	All
Target sample size at registration	60
Key inclusion criteria	1. Children aged 5–10 years at the time of enrolment 2. Children identified as experiencing emotional and/or behavioural difficulties through the adapted Reach Now tool 3. Children who meet the study's eligibility criteria based on the screening and assessment procedures 4. Children living in the selected study areas in Tirana or Kukës 5. Children whose parent or primary caregiver is willing and able to participate in the BLOOM programme and related study assessments 6. A parent or legal guardian who is willing and able to provide informed consent for the child's participation in the study
Key exclusion criteria	1. Children identified through the Brief Eligibility and Safety Assessment as being at imminent risk of suicide, self-harm, or harm to others, requiring a level of care beyond that provided within the study 2. Children or caregivers with severe impairment related to mental, neurological, or substance use disorders (e.g. psychosis, severe intellectual disability, alcohol or drug dependence, or severe eating disorders) that would substantially limit their ability to participate in or benefit from the BLOOM intervention 3. Children identified as experiencing severe child protection concerns or violations that may compromise their immediate safety, including abuse, neglect, exploitation, violence, or other forms of harm, until appropriate safeguarding actions have been initiated and their safety has been assessed 4. Unaccompanied minors who do not have an authorised parent or legal guardian able to provide informed consent for participation in the research study
Date of first enrolment	16/11/2026
Date of final enrolment	15/01/2027

Locations

Countries of recruitment

Albania

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to share	No

Editorial Notes

10/11/2026: Study's existence confirmed by Terre des hommes Albania and the Faculty of Social Sciences, University of Tirana.