Mental HealthWEMANCT07447921
Combining Mental Health and Parenting Interventions to Improve Child Wellbeing Among Refugee Families in Tanzania
A study testing Self Help Plus and Interaction Competencies with Children - for Parents in people with Mental Health and Socio-emotional Well-being, run by Uppsala University at 2 sites in Tanzania.
Trial summary
The goal of this clinical trial is to learn whether improving caregivers' mental health and parenting practices can enhance child wellbeing among Congolese refugee families living in the Nyarugusu Refugee Camp, Tanzania. Read more about this study
- Who is it for?
- Ages 7 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health, Socio-emotional Well-being, Functioning, Psychosocial
- What is being tested?
- Self Help Plus and Interaction Competencies with Children - for Parents
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,296 participants
- Where
- 2 sitesTanzania
- Study dates
- 15 Mar 2026to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Families residing in Nyarugusu Refugee Camp, Tanzania
- Congolese refugee origin (for cultural and linguistic homogeneity)
- Two primary caregivers (one male, one female) aged 18 years or older, caring for at least two children aged 7-10 years
- Ability to speak and understand Kiswahili
- Willingness to provide informed consent (and child assent)
- No plans to leave the camp within the next 12 months
Who cannot join
- Caregivers currently enrolled in other mental health or parenting programs
- Caregivers displaying imminent suicide risk, psychosis, or severe cognitive impairment that would impede participation
- Children with known developmental disabilities reported by caregivers
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Tanzania2 sites
Dar es Salaam University College of Education
Dar es Salaam, Dar es Salaam Region
Dar es Salaam University College of Education
Dar es Salaam, Dar es Salaam Region
Faustine Bwire Masath, PhD, +255 714 662 061, faustine.masath@udsm.ac.tz
About this study
Official title: Combining Mental Health and Violence Prevention Interventions to Enhance Child Wellbeing Under Adversity - Study Protocol for a Three-arm, Cluster-randomized, Superiority Trial With Primary Caregivers in Nyarugusu Refugee Camp, Tanzania (WEMA Trial)
The goal of this clinical trial is to learn whether improving caregivers' mental health and parenting practices can enhance child wellbeing among Congolese refugee families living in the Nyarugusu Refugee Camp, Tanzania. The WEMA trial ("Wellbeing through combined Evidence-based tools for Mental health and Attuned parenting") is a three-arm, family-level cluster-randomized, controlled superiority trial involving 324 families (approximately 648 children aged 7-10 years and their two primary caregivers). Participants and intervention facilitators will know which program a family receives, but outcome assessors (enumerators) will not know group assignment.
The main questions it aims to answer are:
Read more
- Does Self-Help Plus (SH+), a World Health Organization (WHO) group stress-management program, improve children's emotional and behavioral functioning at 12 months post-intervention, compared with usual care?
- Does adding Interaction Competencies with Children for Parents (ICC-P), a participatory parenting program, after SH+ further improve children's emotional and behavioral functioning at 12 months post-intervention, compared with SH+ alone?
Researchers will compare (1) Usual Care, (2) SH+, and (3) SH+ followed by ICC-P to see whether SH+ improves outcomes versus usual care, and whether SH+ followed by ICC-P provides additional benefits beyond SH+ alone.
Participants will:
- Be assigned by chance by family clusters to one of three groups: Usual Care, SH+, or SH+ followed by ICC-P.
- Receive either (a) information about available psychosocial and mental health services (Usual Care), (b) SH+ (five group sessions delivered by trained non-specialists), or (c) SH+ followed by ICC-P (a four-day participatory parenting training to strengthen positive parenting and reduce harsh discipline).
- Complete study assessments at baseline, 3 months, and 12 months post-intervention.
The primary outcome is children's emotional and behavioral functioning, measured using the Pediatric Symptom Checklist-17 (PSC-17) at 12 months post-intervention. Secondary outcomes include children's wellbeing and quality of life, as well as caregivers' mental health, well-being, and parenting practices. Additional exploratory outcomes will also be assessed, including measures collected from caregivers and behavioral tasks with children.
The trial is implemented by Uppsala University in collaboration with the Dar es Salaam University College of Education (DUCE) and partners, with funding from the Swedish Research Council (grant no. 2022-02476).
- Being tested
- Self Help Plus, Interaction Competencies with Children - for Parents
- Keywords
- Mental health, Child development, Parenting, Refugees, Self-Help Plus, Interaction Competencies with Children - for Parents, Tanzania
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self Help PlusBehavioural
The Self-Help Plus (SH+) intervention is a stress management program developed by the World Health Organization (WHO). It is based on Acceptance and Commitment Therapy and designed for use in resource-limited and humanitarian settings. SH+ is delivered in five group sessions led by trained non-specialist facilitators using pre-recorded audio, structured manuals, and illustrated participant guides in Kiswahili. The program teaches practical skills for coping with stress and managing difficult thoughts and emotions. Each session lasts approximately two hours and includes individual reflection and guided group discussion.
Interaction Competencies with Children - for ParentsBehavioural
ICC-P is a four-day, group-based intervention designed to strengthen positive parenting and reduce harsh or violent discipline. It combines theoretical input with practical exercises, group discussions, and role-playing. A refresher session is held six weeks later to reinforce learning and promote sustainability. Both interventions are delivered by trained facilitators under supervision to ensure fidelity.
| Study group | Role | What they receive |
|---|---|---|
| Self Help plus | Experimental | Families assigned to this arm receive the World Health Organization's Self-Help Plus (SH+), a brief, group-based stress-management program for caregivers. The two primary caregivers in each family participate. SH+ is delivered by trained non-specialist facilitators using a standardized, audio-guided format with an illustrated self-help manual and structured group discussion. The program consists of five sessions (about two hours each), with at least three days between sessions. Receives: Behavioral: Self Help Plus |
| Self-Help Plus + Interaction Competencies with Children - for Parents (SH+ + ICC-P) | Experimental | Families assigned to this arm receive SH+ first, followed by Interaction Competencies with Children for Parents (ICC-P). The two primary caregivers in each family participate. SH+ is delivered as described above (five group sessions, approximately two hours each, spaced at least three days apart, delivered by trained non-specialists using standardized audio-guided materials and an illustrated manual). After SH+ is completed, caregivers receive ICC-P, a participatory parenting program designed to strengthen positive, responsive caregiving and reduce harsh or violent discipline. ICC-P is delivered as three consecutive full training days plus one refresher training day six weeks later, following a manualized group format. Receives: Behavioral: Self Help Plus; Behavioral: Interaction Competencies with Children - for Parents |
| Usual Care (Control) | No intervention | Participants in this arm receive Usual Care (UC). At baseline, caregivers are provided with a standardized information leaflet describing existing mental health and psychosocial support services available in the refugee camp, including organization names, contact information, and types of services offered. No structured intervention is delivered as part of this arm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caregiver-reported child emotional and behavioral functioning (Pediatric Symptom Checklist-17, PSC-17)
Emotional and behavioral functioning of children aged 7-10 years will be assessed using the Pediatric Symptom Checklist-17 (PSC-17), a 17-item caregiver-report screening tool for psychosocial problems (total score range 0-34; higher scores indicate greater difficulties). Each child's PSC-17 will be completed independently by both primary caregivers. The primary outcome metric is the mean (average) of the two caregiver-reported PSC-17 total scores for each child at 12 months post-intervention. PSC-17 subscales (internalizing, externalizing, attention) will be examined in secondary/exploratory analyses.
Measured: Baseline, 3 months post-intervention, and 12 months post-intervention
Secondary outcomes (12)
Self-reported child emotional and behavioral functioning (Youth-adapted Pediatric Symptom Checklist-17, Y-PSC-17)
Mental health problems in children will be assessed using a youth self-report version of the Pediatric Symptom Checklist-17 (PSC-17), adapted for child administration with newly developed pictorial response aids. The measure includes 17 items rated on a 3-point scale (Never, Sometimes, Often; scored 0-2) and summed to a total score (0-34), with higher scores indicating greater emotional/behavioral difficulties. Subscale scores for internalizing, externalizing, and attention problems will also be derived and examined separately.
Measured: Baseline and 12-months post-intervention
Child health-related quality of life (KINDL-R)
Children's health-related quality of life will be assessed using the revised KINDL questionnaire (KINDL-R), which measures well-being across six domains: physical, emotional, self-esteem, family, friends, and school. Both the 24-item child self-report (Kid-KINDL-R) and parent proxy versions will be used. Items are rated on a 5-point Likert scale, with higher scores indicating better quality of life.
Measured: Baseline, 3 months post-intervention, and 12 months post-intervention
Psychological distress (Kessler Psychological Distress Scale, K6)
General psychological distress among caregivers will be assessed using the 6-item Kessler Psychological Distress Scale (K6). Items capture symptoms of anxiety and depression experienced during the past month. Each item is scored from 0 ("none of the time") to 4 ("all of the time"), with higher scores reflecting greater distress.
Measured: Baseline, 3 months post-intervention, and 12 months post-intervention
Depression (Patient Health Questionnaire-9, PHQ-9)
Caregiver depression symptoms will be measured using the 9-item Patient Health Questionnaire (PHQ-9). Items assess frequency of depressive symptoms during the past two weeks on a 4-point scale (0-3), with higher scores indicating greater severity of depression.
Measured: Baseline, 3 months post-intervention, and 12 months post-intervention
Anxiety (Generalized Anxiety Disorder 7-item scale, GAD-7)
Symptoms of generalized anxiety among caregivers will be assessed using the GAD-7. The 7 items rate frequency of core anxiety symptoms over the past two weeks on a scale from 0 ("not at all") to 3 ("nearly every day"). Higher scores indicate greater anxiety severity.
Measured: Baseline, 3 months post-intervention, and 12 months post-intervention
Post-traumatic stress symptoms (PTSD Checklist-Civilian Version, PCL-C)
Caregiver post-traumatic stress symptoms will be assessed with the 6-item PTSD Checklist-Civilian Version (PCL-C). Each symptom is rated on a 5-point scale from "not at all" to "extremely," with total scores ranging from 6 to 30. Higher scores indicate greater PTSD symptom severity.
Measured: Baseline, 3 months post-intervention, and 12 months post-intervention
Subjective wellbeing (WHO-5 Well-Being Index)
The WHO-5 Well-Being Index will assess caregivers' subjective wellbeing. It consists of five items rated from 0 ("at no time") to 5 ("all of the time") reflecting mood, vitality, and general interest. The total score (0-25) is multiplied by 4 to yield a final index ranging from 0 to 100, where higher scores indicate better wellbeing.
Measured: Baseline, 3 months post-intervention, and 12 months post-intervention
Functional impairment (WHO Disability Assessment Schedule 2.0, WHODAS-II)
Functional impairment among caregivers will be measured using the 15-item WHO Disability Assessment Schedule 2.0 (WHODAS-II). Items assess difficulties in understanding, mobility, self-care, interpersonal relationships, daily activities, and participation, scored from 0 ("none") to 4 ("extreme or cannot do"). Higher scores indicate greater functional impairment.
Measured: Baseline and 12 months post-intervention
Psychological flexibility (Acceptance and Action Questionnaire-II, AAQ-II)
Psychological flexibility will be measured using the 7-item Acceptance and Action Questionnaire-II (AAQ-II). Items are rated on a 7-point Likert scale (1 = "never true," 7 = "always true"), and scores are reversed so that higher totals indicate greater psychological flexibility.
Measured: Baseline, 3 months post-intervention, and 12 months post-intervention
Positive parenting (Alabama Parenting Questionnaire - Positive Parenting Subscale)
Positive parenting practices will be measured using the 6-item Positive Parenting Subscale of the Alabama Parenting Questionnaire (APQ). Items assess the frequency of positive interactions between parents and children on a 5-point scale from "never" to "always," with higher scores indicating greater use of positive parenting behaviors.
Measured: Baseline, 3 months post-intervention, and 12 months post-intervention
Child-reported maltreatment (Child-Reported CTSPC)
Child-reported maltreatment will be assessed with a pictorial adaptation of the Parent-Child Conflict Tactics Scale (CTSPC). The instrument includes 22 items rated on a 7-point frequency scale for the past month; higher scores indicate more frequent maltreatment experiences.
Measured: Baseline and 12 months post-intervention
Child discipline/maltreatment (caregiver report): UNICEF MICS Child Discipline Module
Caregiver-reported child discipline will be assessed using the UNICEF Multiple Indicator Cluster Surveys (MICS) Child Discipline Module, which includes 11 yes/no items capturing both non-violent and violent discipline practices in the past month. Summary indices are derived from the item responses; higher values indicate more frequent use of harsh/violent discipline practices.
Measured: Baseline, 3 months post-intervention, and 12 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start15 Mar 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,296 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Bielefeld University, University of Konstanz, Dar es Salaam University College of Education, University of North Carolina, Charlotte
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07447921
- Sponsor's protocol ID
- 2022-02476
- Acronym
- WEMA
- Status last verified
- Feb 2026
- First submitted
- 25 Feb 2026
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to the sensitive nature of the data and the vulnerability of the study population, including refugee parents and children, individual participant data (IPD) will not be shared. Data privacy concerns and ethical constraints related to participant protection in a humanitarian setting prevent open sharing of de-identified datasets.
Publications
Kabelege E, Kirika A, Nkuba M, Hermenau K, Schreiber A, Hoeffler A, Hecker T. Improving Parent-Child Interaction and Reducing Parental Violent Discipline - a Multi-Informant Multi-Method Pilot Feasibility Study of a School-Based Intervention. J Fam Violence. 2025;40:799-810. doi: 10.1007/s10896-023-00679-4.
Tol WA, Leku MR, Lakin DP, Carswell K, Augustinavicius J, Adaku A, Au TM, Brown FL, Bryant RA, Garcia-Moreno C, Musci RJ, Ventevogel P, White RG, van Ommeren M. Guided self-help to reduce psychological distress in South Sudanese female refugees in Uganda: a cluster randomised trial. Lancet Glob Health. 2020 Feb;8(2):e254-e263. doi: 10.1016/S2214-109X(19)30504-2.
PubMed 31981556
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining Mental Health and Violence Prevention Interventions to Enhance Child Wellbeing Under Adversity - Study Protocol for a Three-arm, Cluster-randomized, Superiority Trial With Primary Caregivers in Nyarugusu Refugee Camp, Tanzania (WEMA Trial)
- ClinicalTrials.gov ID
- NCT07447921
- Acronym / sponsor ID
- WEMA / 2022-02476
- Keywords
- Mental health, Child development, Parenting, Refugees, Self-Help Plus, Interaction Competencies with Children - for Parents, Tanzania
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,296 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Bielefeld University, University of Konstanz, Dar es Salaam University College of Education, University of North Carolina, Charlotte
- Study start
- 15 Mar 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 4 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn whether improving caregivers' mental health and parenting practices can enhance child wellbeing among Congolese refugee families living in the Nyarugusu Refugee Camp, Tanzania. The WEMA trial ("Wellbeing through combined Evidence-based tools for Mental health and Attuned parenting") is a three-arm, family-level cluster-randomized, controlled superiority trial involving 324 families (approximately 648 children aged 7-10 years and their two primary caregivers). Participants and intervention facilitators will know which program a family receives, but outcome assessors (enumerators) will not know group assignment.
The main questions it aims to answer are:
- Does Self-Help Plus (SH+), a World Health Organization (WHO) group stress-management program, improve children's emotional and behavioral functioning at 12 months post-intervention, compared with usual care?
- Does adding Interaction Competencies with Children for Parents (ICC-P), a participatory parenting program, after SH+ further improve children's emotional and behavioral functioning at 12 months post-intervention, compared with SH+ alone?
Researchers will compare (1) Usual Care, (2) SH+, and (3) SH+ followed by ICC-P to see whether SH+ improves outcomes versus usual care, and whether SH+ followed by ICC-P provides additional benefits beyond SH+ alone.
Participants will:
- Be assigned by chance by family clusters to one of three groups: Usual Care, SH+, or SH+ followed by ICC-P.
- Receive either (a) information about available psychosocial and mental health services (Usual Care), (b) SH+ (five group sessions delivered by trained non-specialists), or (c) SH+ followed by ICC-P (a four-day participatory parenting training to strengthen positive parenting and reduce harsh discipline).
- Complete study assessments at baseline, 3 months, and 12 months post-intervention.
The primary outcome is children's emotional and behavioral functioning, measured using the Pediatric Symptom Checklist-17 (PSC-17) at 12 months post-intervention. Secondary outcomes include children's wellbeing and quality of life, as well as caregivers' mental health, well-being, and parenting practices. Additional exploratory outcomes will also be assessed, including measures collected from caregivers and behavioral tasks with children.
The trial is implemented by Uppsala University in collaboration with the Dar es Salaam University College of Education (DUCE) and partners, with funding from the Swedish Research Council (grant no. 2022-02476).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Self Help plus | Experimental | Behavioral: Self Help PlusFamilies assigned to this arm receive the World Health Organization's Self-Help Plus (SH+), a brief, group-based stress-management program for caregivers. The two primary caregivers in each family participate. SH+ is delivered by trained non-specialist facilitators using a standardized, audio-guided format with an illustrated self-help manual and structured group discussion. The program consists of five sessions (about two hours each), with at least three days between sessions. |
| Self-Help Plus + Interaction Competencies with Children - for Parents (SH+ + ICC-P) | Experimental | Behavioral: Self Help Plus, Behavioral: Interaction Competencies with Children - for ParentsFamilies assigned to this arm receive SH+ first, followed by Interaction Competencies with Children for Parents (ICC-P). The two primary caregivers in each family participate. SH+ is delivered as described above (five group sessions, approximately two hours each, spaced at least three days apart, delivered by trained non-specialists using standardized audio-guided materials and an illustrated manual). After SH+ is completed, caregivers receive ICC-P, a participatory parenting program designed to strengthen positive, responsive caregiving and reduce harsh or violent discipline. ICC-P is delivered as three consecutive full training days plus one refresher training day six weeks later, following a manualized group format. |
| Usual Care (Control) | No intervention | –Participants in this arm receive Usual Care (UC). At baseline, caregivers are provided with a standardized information leaflet describing existing mental health and psychosocial support services available in the refugee camp, including organization names, contact information, and types of services offered. No structured intervention is delivered as part of this arm. |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Families residing in Nyarugusu Refugee Camp, Tanzania
- Congolese refugee origin (for cultural and linguistic homogeneity)
- Two primary caregivers (one male, one female) aged 18 years or older, caring for at least two children aged 7-10 years
- Ability to speak and understand Kiswahili
- Willingness to provide informed consent (and child assent)
Key exclusion criteria (3 listed)
- Caregivers currently enrolled in other mental health or parenting programs
- Caregivers displaying imminent suicide risk, psychosis, or severe cognitive impairment that would impede participation
- Children with known developmental disabilities reported by caregivers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self Help PlusThe Self-Help Plus (SH+) intervention is a stress management program developed by the World Health Organization (WHO). It is based on Acceptance and Commitment Therapy and designed for use in resource-limited and humanitarian settings. SH+ is delivered in five group sessions led by trained non-specialist facilitators using pre-recorded audio, structured manuals, and illustrated participant guides in Kiswahili. The program teaches practical skills for coping with stress and managing difficult thoughts and emotions. Each session lasts approximately two hours and includes individual reflection and guided group discussion. | Behavioural | Self Help plus, Self-Help Plus + Interaction Competencies with Children - for Parents (SH+ + ICC-P) |
| Interaction Competencies with Children - for ParentsICC-P is a four-day, group-based intervention designed to strengthen positive parenting and reduce harsh or violent discipline. It combines theoretical input with practical exercises, group discussions, and role-playing. A refresher session is held six weeks later to reinforce learning and promote sustainability. Both interventions are delivered by trained facilitators under supervision to ensure fidelity. | Behavioural | Self-Help Plus + Interaction Competencies with Children - for Parents (SH+ + ICC-P) |
Primary outcome
Caregiver-reported child emotional and behavioral functioning (Pediatric Symptom Checklist-17, PSC-17)
Time frame: Baseline, 3 months post-intervention, and 12 months post-intervention
Emotional and behavioral functioning of children aged 7-10 years will be assessed using the Pediatric Symptom Checklist-17 (PSC-17), a 17-item caregiver-report screening tool for psychosocial problems (total score range 0-34; higher scores indicate greater difficulties). Each child's PSC-17 will be completed independently by both primary caregivers. The primary outcome metric is the mean (average) of the two caregiver-reported PSC-17 total scores for each child at 12 months post-intervention. PSC-17 subscales (internalizing, externalizing, attention) will be examined in secondary/exploratory analyses.
12 secondary outcomes
Self-reported child emotional and behavioral functioning (Youth-adapted Pediatric Symptom Checklist-17, Y-PSC-17)
Time frame: Baseline and 12-months post-intervention
Child health-related quality of life (KINDL-R)
Time frame: Baseline, 3 months post-intervention, and 12 months post-intervention
Psychological distress (Kessler Psychological Distress Scale, K6)
Time frame: Baseline, 3 months post-intervention, and 12 months post-intervention
Depression (Patient Health Questionnaire-9, PHQ-9)
Time frame: Baseline, 3 months post-intervention, and 12 months post-intervention
Anxiety (Generalized Anxiety Disorder 7-item scale, GAD-7)
Time frame: Baseline, 3 months post-intervention, and 12 months post-intervention
Post-traumatic stress symptoms (PTSD Checklist-Civilian Version, PCL-C)
Time frame: Baseline, 3 months post-intervention, and 12 months post-intervention
Subjective wellbeing (WHO-5 Well-Being Index)
Time frame: Baseline, 3 months post-intervention, and 12 months post-intervention
Functional impairment (WHO Disability Assessment Schedule 2.0, WHODAS-II)
Time frame: Baseline and 12 months post-intervention
Psychological flexibility (Acceptance and Action Questionnaire-II, AAQ-II)
Time frame: Baseline, 3 months post-intervention, and 12 months post-intervention
Positive parenting (Alabama Parenting Questionnaire - Positive Parenting Subscale)
Time frame: Baseline, 3 months post-intervention, and 12 months post-intervention
Child-reported maltreatment (Child-Reported CTSPC)
Time frame: Baseline and 12 months post-intervention
Child discipline/maltreatment (caregiver report): UNICEF MICS Child Discipline Module
Time frame: Baseline, 3 months post-intervention, and 12 months post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- BackgroundKabelege E, Kirika A, Nkuba M, Hermenau K, Schreiber A, Hoeffler A, Hecker T. Improving Parent-Child Interaction and Reducing Parental Violent Discipline - a Multi-Informant Multi-Method Pilot Feasibility Study of a School-Based Intervention. J Fam Violence. 2025;40:799-810. doi: 10.1007/s10896-023-00679-4.
- Background: PubMed 31981556Tol WA, Leku MR, Lakin DP, Carswell K, Augustinavicius J, Adaku A, Au TM, Brown FL, Bryant RA, Garcia-Moreno C, Musci RJ, Ventevogel P, White RG, van Ommeren M. Guided self-help to reduce psychological distress in South Sudanese female refugees in Uganda: a cluster randomised trial. Lancet Glob Health. 2020 Feb;8(2):e254-e263. doi: 10.1016/S2214-109X(19)30504-2.
- Individual participant dataSharing planned: No. Due to the sensitive nature of the data and the vulnerability of the study population, including refugee parents and children, individual participant data (IPD) will not be shared. Data privacy concerns and ethical constraints related to participant protection in a humanitarian setting prevent open sharing of de-identified datasets.
Related trials for Mental Health
Not yet recruitingObservational study
A Natural History of Cardiometabolic Disease Among US Bhutanese: Developing the Cross-Sectional Bhutanese Community of Central Ohio Health Study to Understand Acculturation as Synergizing Socioenvironmental and Biobehavioral Risk Factors Propagating ...
Cardiometabolic Risk Factors, Mental Health
Not yet recruiting
Pilot Study to Co-create and Implement a Multicomponent Intervention to Reduce Mental Health Stigma in Primary Care
Mental Health, Stigma of Mental Illness
RecruitingObservational study
Women s Health Awareness Community Resiliency, Environmental Action and Collaborations for Health (REACH)
Mental Health
Not yet recruiting
Inflammatory Pathways Modulated by Prenatal Mindfulness: A Route to Improve Maternal Child Emotional Well Being and Whole Person Health
Inflammation, Depression Disorder
Recruiting
Fathers and Babies (FAB) Research Study
Perinatal Mental Health, Fathers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self Help Plus and Interaction Competencies with Children - for Parents in people with Mental Health and Socio-emotional Well-being, run by Uppsala University at 2 sites in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jonathan Hall, PhD (+46709948737, jonathan.hall@pcr.uu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caregiver-reported child emotional and behavioral functioning (Pediatric Symptom Checklist-17, PSC-17) (time frame: Baseline, 3 months post-intervention, and 12 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07447921, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026; AzTrials last refreshed its copy on 26 Oct 2026.