Healing the emotional wounds of illegal child workers through a co-produced arts-based program: a multi-country feasibility study

ISRCTN	ISRCTN68396872
DOI	https://doi.org/10.1186/ISRCTN68396872
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	ES/X012131/1
Sponsor	Queen Mary University of London
Funder	Economic and Social Research Council

Submission date: 20/05/2025
Registration date: 28/05/2025
Last edited: 12/08/2025

Recruitment status: 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

Background and study aims
Child labour refers to paid and unpaid work carried out by children that is detrimental to and endangers them. Child labour affects up to one in four children from low- and medium-income countries and deprives young people of their education, future opportunities and prosperity. Eradicating child labour is an urgent priority for governments and non-governmental organisations. In some Asian countries, “rehabilitation programmes” have been developed to help remove young people from illegal employment, provide shelter, food, legal and medical assistance, and re-integrate children with their families and in education. A major barrier to these programmes is managing the mental health of rescued child labourers. Many child labourers were victimised, abused and experienced symptoms of anxiety, depression and post-traumatic stress. These “emotional wounds” are likely to affect young people’s reintegration into education.
Delivering interventions to help child labourers improve their mental well-being is an important priority. Yet there is a lack of evidence-based programmes addressing the emotional symptoms of child labourers. Arts-based programmes can reduce emotional symptoms amongst young people who have experienced trauma from high-income countries. Child labourers have also reported that they find the use of the arts in their healing helpful because it enables them to share experiences and connect with peers. Arts-based programmes developed in high-income countries may require tailoring to increase their accessibility to child labourers from low- and middle-income countries. The aim of this study is to co-adapt, deliver and formatively evaluate an arts-based group programme for rescued child labourers from India, Bangladesh and Nepal.

Who can participate?
Young people aged 12-17 years rescued from child labour living in Delhi (India), Dhaka (Bangladesh) and Kathmandu (Nepal). Young people need to have a history of child labour that occurred before 14 years of age and lasted for a minimum of 6 months. Young people need to have symptoms of depression or anxiety and to be able to participate in a group arts-based programme which involves: understanding everyday language, able to express themselves verbally, tolerate a group setting and not to have a physical or intellectual disability or any time commitments that would prevent participation e.g. leaving a shelter soon. Young people who are currently suicidal, self-harming or receiving intensive psychological therapy are not eligible to participate in this study.

What does the study involve?
The study involves co-adaptation, delivery and evaluation of an arts-based programme.
Stage 1 of the study will involve co-adaptation of creative psychological therapy called “Arts for Blues”, making it fit for purpose (clinically and culturally relevant and engaging) for young people with a history of illegal child work in Bangladesh, India and Nepal. The UK-based arts therapists and creative practitioners from India, Bangladesh and Nepal will collaborate to co-adapt this programme to child labourers living in these three countries, integrating the perspectives of people with experience of child labour and shelter staff that support child labourers.
Stage 2 will involve refinement of the co-adapted arts-based programme. Young people (aged 12-17 years) rescued from child labour and living at shelters in India, Bangladesh and Nepal will be invited to participate in the programme (7 young people from each country). Young people, staff members at shelters and creative practitioners who delivered the programme will be asked to participate in an interview to provide feedback on the programme (e.g. what they found helpful or not). The perspectives of young people, shelter staff and creative practitioners will be incorporated in the refinement of the arts-based programme.
Stage 3 of the study will involve the delivery and evaluation of an arts-based programme. Young people (aged 12-17 years) rescued from child labour will be invited to participate in the evaluation of the programme (56 young people from each country). The researchers will use a computer procedure (like flipping a coin) to randomly allocate half of the young people (28 young people) to receive the arts-based programme and another half (28 young people) to continue to receive standard re-integration programmes provided at shelters to evaluate the programme. All participating young people will be asked to complete questionnaires about depression, anxiety and post-traumatic stress before, during and after the start of the study. The arts-based programme will be delivered by two creative practitioners in a group of seven rescued child labourers in the shelters where young people live. The programme will involve arts-based activities (e.g. drawings, colourings, dance and music) aimed at expressing and processing emotions and developing relationships with the group. Young people who participated in the arts-based programme and shelter staff will be invited to take part in interviews to provide feedback on the programme. Young people who participated in the programme will also be invited to complete a “body map” to share their views on the programme via drawings, paintings and other art materials.
Stage 4 of the study will involve sharing the findings of this project with stakeholders and organisations that support child labourers in each country.

What are the possible benefits and risks of participating?
Eradicating child labour is a target of the United Nations Sustainable Development Goals and an important priority for the India, Nepal and Bangladesh governments. However, parallel efforts to rescue and re-integrate child labourers are also a priority. The primary beneficiaries of this and the next phases of this research will be young people with a history of child labour who are navigating daily routines while also managing the emotional impact of illegal work and associated victimisation. The researchers hope that this research will also eventually benefit those currently illegally working too. Secondary beneficiaries include those aiming to provide mental health support to these young people: non-governmental organisations providing shelters and re-integration programmes, public health policymakers, schools and those working in clinical, health and social services.
Young people, shelter staff and creative practitioners will be asked to spare their time to take part in the study. The arts-based programme and data collection for young people might evoke some negative past experiences. The research team and creative practitioners delivering the programme are trained to work with young people with mental health difficulties. In the arts-based programme and data collection sessions, if a young person starts showing any signs of distress, the session will be terminated immediately, and shelter staff and/or parents will be informed about this. If a young person tells researchers and creative practitioners that he or she is in immediate danger or at risk of harm according to local laws, the researchers will have to share this information with relevant safeguarding bodies so that the young person can receive help.

Where is the study run from?
The study is being carried out in Delhi (India), Dhaka (Bangladesh) and Kathmandu (Nepal). Queen Mary University of London (UK) is leading the study.

When is the study starting and how long is it expected to run for?
July 2024 to July 2027

Who is funding the study?
Economic Social and Research Council (ES/X012131/1) (UK)

Who is the main contact?
1. Dr Laura Paulauskaite, l.paulauskaite@qmul.ac.uk
2. Prof. Jennifer Lau, j.lau@qmul.ac.uk

Contact information

Prof Jennifer Lau
Principal investigator

Yvonne Carter Building
58 Turner St
London
E1 2AB
United Kingdom

ORCID ID	0000-0001-8220-3618
Email	j.lau@qmul.ac.uk

Dr Laura Paulauskaite
Public, Scientific

Yvonne Carter Building
58 Turner St
London E1 2AB
London
E1 2AB
United Kingdom

ORCID ID	0000-0002-7892-8103
Email	l.paulauskaite@qmul.ac.uk

Study information

Primary study design	Interventional
Study design	Three parallel two-group randomized controlled trials
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Healing the emotional wounds of illegal child workers through a co-produced arts-based program: a multi-country feasibility study
Study acronym	CREATE
Study objectives	The overall aim of the study is to co-adapt and formatively evaluate an arts-based programme to reduce emotional distress and build re-integration into society in rescued child labourers from India, Bangladesh and Nepal. The overall aim will be achieved through four specific objectives: 1. To co-adapt an evidence-based, creative arts-based therapeutic programme called “Arts for Blues” (Haslam et al., 2019; Parsons et al., 2023), making it fit for purpose (clinically and culturally relevant and engaging) for young people with a history of illegal child work in Bangladesh, India and Nepal. Co-adaptation will occur through collaborations between UK-based arts therapists and local creative practitioners, as well as input from other key stakeholder groups such as people with lived experience of child labour and key workers within shelters. 2. To pilot and refine the arts-based programme and data collection process by integrating the perspectives of young people rescued from child labour and staff who work closely with them. This objective will be achieved by delivering the programme to young people rescued from child labour in each of the three countries and seeking feedback from the participants and shelter staff. This will ensure that the programme reflects their clinical and psychosocial needs and preferences and aligns well with norms and practices in local cultural contexts. 3. To formatively evaluate this programme for feasibility, acceptability and therapeutic promise in young people rescued from child labour in India, Bangladesh and Nepal in a feasibility randomised controlled trial (RCT). 4. To disseminate the findings of the study to stakeholders and organisations that support child labourers in each country.
Ethics approval(s)	Approved 10/07/2025, Nepal Health Research Council (NHRC) (Government of Nepal, Ramshah Path, Katmandu, -, Nepal; +977 (0)1 5354220 / +977 (0)1 5327460 / +977 (0)1 5346008; nhrc@nhrc.gov.np), ref: 153 – 2025
Health condition(s) or problem(s) studied	Symptoms of depression, anxiety, post-traumatic stress and low mental well-being of rescued child labourers
Intervention	The researchers will carry out three parallel two-group randomised controlled trials (RCTs) in Bangladesh, India and Nepal (one per country), where the primary aim is to assess feasibility and acceptability of an arts-based therapeutic programme, and the secondary aim is to assess the range of effect sizes associated with changes on emotional symptoms and well-being. For each RCT, 56 participants will be randomly allocated to either receive the intervention (around 12 sessions, n = 28) or the standard re-integration programme (treatment as usual, offered by shelters, n = 28). The 28 in the intervention group will be split into 4 groups of 7 participants each for the purpose of delivering the intervention in a group setting. Potential participants will be recruited through shelters in Dhaka (Bangladesh), Delhi (India) and Kathmandu (Nepal) and neighbouring regions. The randomisation will be stratified by sex and age band. In each country, the arts-based programme will be delivered by creative practitioners (involved in objectives 1 and 2) in groups of seven rescued child labourers in the shelters where young people reside. The programme will involve arts-based activities (e.g. drawings, colourings, dance and music) aimed at expressing and processing emotions and developing relationships with the group. The delivery schedule and the composition of groups (mixed age/sex) will follow the recommendations of participants and shelter staff from objective 2. The content of the programme will also be adapted based on the findings of the objectives (1 and 2) and consultations with a Lived Experience Advisory Panel.
Intervention type	Mixed
Primary outcome measure(s)	Feasibility and acceptability of the arts-based programme. To assess feasibility, the researchers will collect the following numbers for each country separately but also aggregated across countries: a) shelters contacted, b) shelters agreed, c) participants screened, d) potentially eligible participants, e) participants consenting to take part and completing the baseline assessment, f) participants consenting to be randomised, g) participants completing the 1-week post-assessment, h) participants completing the 3-month assessment, i) mean number and range of intervention sessions completed, and j) data completeness for each symptom measure. To evaluate feasibility, the researchers will calculate uptake at the level of the shelter (proportion of shelters who agree from those contacted) and individual (proportion of young people who consented and assented from those who were eligible and invited) and the retention of individual participants (proportion of young people who complete the 3-month follow-up assessment from amongst those who completed the baseline assessment). Acceptability will be assessed through engagement, tolerability, and safety. To evaluate these aspects of acceptability, all participants in the intervention group will be asked to rate the intervention for how much they liked/disliked it, found it helpful/unhelpful, the degree of motivation to attend sessions, and whether they would recommend it to a friend. Any serious adverse events (SAEs) directly linked to the study will be noted as a further index of safety. Young people who received the intervention (n = 7 per country) will be invited to in-depth individual interviews. Topic guides were developed by the research team. However, once they receive ethical approvals, the researchers will ask the Lived Experience Advisory Panel to review the language used in the topic guides. Topic guides include questions around young peoples’ perceptions of the intervention: whether participants found the intervention enjoyable and helpful, whether there were any aspects that made them feel uncomfortable/upset/unsafe, what they had learnt, whether they thought they would continue to use the exercises, barriers to attendance, and if they would recommend it to others. Young people who participated in the programme will also be invited to participate in a visual data collection session that will involve sharing their views on the programme, its acceptability and potential therapeutic benefits via drawings, paintings, pictures and other arts material (a completion of a “body map” activity). Two to three shelter staff per country will also be interviewed on their experiences of the intervention delivered in the shelter, including opportunities, barriers and alternative solutions. Interviews with creative practitioners who delivered the arts-based programme will also be carried out to find their perspectives about how the delivery of the programme went, to understand key aspects of the programme and potential ways of improving the programme. To determine whether the study should proceed to a definitive efficacy trial, the researchers will decide, using the following progression criteria relating to feasibility and acceptability: 1. Recruitment feasibility: Of the potentially suitable participants, <30% agreed to take part (red); Of the potentially suitable participants, ≥ 30%-50% agreed to provide consent (amber); Of the potentially suitable, ≥ 50% agreed to provide consent (green). 2. Retention in data collection: Of those enrolled, <33% of young people provide post intervention data (1 week-post) (red); Of those enrolled, 30%-50% of young people provide post intervention data (1 week-post) (amber); Of those enrolled, ≥ 50% of young people provide post intervention data (1 week-post) (green). 3. Acceptability of arts-based programme: A score of ≤ 3 (Likert scale 1-5) on average in 60% or more of participants who completed the programme (red); A score of ≤ 3 (Likert scale 1-5) on average in 40% or more of participants who completed the programme (amber); A score of ≤3 (Likert scale 1-5) on average in 20% or more of participants who completed the programme (green). 4. Programme adherence: < 25% of participants attend at least 9 sessions out of 12 offered sessions (red); ≥ 25% of participants attend at least 9 sessions out of 12 offered sessions (amber); ≥ 50% of participants attend at least 9 sessions out of 12 offered sessions (green). 5. Serious Adverse Events during participation in arts-based programme: A serious adverse event occurred related to programme (red); A serious adverse event related to programme or likely related to the programme occurred in 20% of young people (amber); No serious adverse events occurred related to the programme (green). The researchers have based these on discussions amongst the research teams and from similar studies in these countries. They have also shared these with shelter staff for their input.
Key secondary outcome measure(s)	1. Symptoms of depression measured using a self-report questionnaire - the Patient Health Questionnaire (PHQ-8) at baseline, weekly during the intervention (6 weeks), 1 week post the intervention and 3 months post the intervention. 2. Symptoms of anxiety measured using a self-report questionnaire - the Generalised Anxiety Disorder Questionnaire (GAD-7) at baseline, weekly during the intervention (6 weeks), 1 week post the intervention and 3 months post the intervention 3. Post-traumatic stress symptoms measured using a self-report questionnaire - the Child Revised Impact of Events Scale (CRIES-8) at baseline, weekly during the intervention (6 weeks), 1 week post the intervention and 3 months post the intervention 4. Emotional and behavioural problems measured using a self-report and informant-report questionnaire - the Strengths and Difficulties Questionnaire (SDQ) at baseline, weekly during the intervention (6 weeks), 1 week post the intervention and 3 months post the intervention 5. Mental well-being measured using the Warwick-Edinburgh Mental Wellbeing Scales (WEMWBS) at baseline, weekly during the intervention (6 weeks), 1 week post the intervention and 3 months post the intervention
Completion date	31/07/2027

Eligibility

Participant type(s)	Service user
Age group	Child
Lower age limit	12 Years
Upper age limit	17 Years
Sex	All
Target sample size at registration	189
Key inclusion criteria	1. Rescued from child labour and is not currently engaged in child labour 2. Aged 12-17 years 3. Has a history of child labour that occurred before 14 years of age for at least 6 months 4. Has symptoms of anxiety or depression measured by the Youth Inventory-4R (YI-4R) scale 5. Is not currently suicidal or self-harming 6. Does not receive intensive psychotherapy 7. Able to participate in a group setting (e.g. able to cope with being in a group) 8. Has expressive and receptive verbal communication skills 9. Does not have intellectual disability 10. Does not have physical disability that would prevent participation in arts activities 11. Does not plan to leave the shelter soon and has time to participate in the programme
Key exclusion criteria	1. Currently engaged in child labour 2. Aged <12 years or >17 years 3. Does not have a history of child labour that occurred before 14 years of age for at least 6 months 4. Does not have symptoms of anxiety or depression measured by the Youth Inventory-4R (YI-4R) scale 5. Is currently suicidal or self-harming 6. Receives intensive psychotherapy 7. Not able to participate in a group setting (e.g. not able to cope with being in a group) 8. Does not have expressive and receptive verbal communication skills 9. Has intellectual disability 10. Has a physical disability that would prevent participation in arts activities 11. Plans to leave the shelter soon and has no time to participate in the programme
Date of first enrolment	13/08/2025
Date of final enrolment	19/06/2027

Locations

Countries of recruitment

Bangladesh
India
Nepal

Study participating centres

Tribhuvan University

Kathmandu
-
Nepal

University of Dhaka

Nilkhet Rd
Dhaka
Dhaka 1000
Bangladesh

Banaras Hindu University

Ajagara
Varanasi
Uttar Pradesh 221005
India

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Stored in publicly available repository
IPD sharing plan	The datasets generated during and/or analysed during the current study will be stored in publicly available repositories (Queen Mary Research Online; https://qmro.qmul.ac.uk/xmlui/ and ReShare https://reshare.ukdataservice.ac.uk/). Only de-identified (without participants’ names and any other personal information) quantitative data collected in this study (e.g. scores on secondary outcomes) will be stored in publicly available repositories. Qualitative data will not be stored in repositories due to the sensitive nature of the data and the potential of compromising confidentiality. The quantitative data will be available within 3 months of the end of the study and will be preserved for the long term. The quantitative data will be made available under safeguarded access, subject to the End User Licence conditions, and prohibiting commercial use. Consents from participants will be sought for storing the de-identified data collected in this study in the repositories. Only the data that will have participants’ consent will be stored in the repositories.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

12/08/2025: Ethics approval details added. The date of first enrolment was changed from 10/07/2025 to 13/08/2025.
16/06/2025: The recruitment start date was changed from 19/06/2025 to 10/07/2025.
20/05/2025: Study's existence confirmed by the Economic and Social Research Council.