An interventional study of Self Help Plus and Interaction Competencies with Children - for Parents in Mental Health, Socio-emotional Well-being and Functioning, Psychosocial, sponsored by Uppsala University. Not yet recruiting at 2 sites in Tanzania. Open to participants aged 7 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-04.
Sponsored by Uppsala University · Not applicable, Interventional, and Treatment
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:
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:
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).
2,193 studies on the registry are indexed under Psychological Well-Being; 728 are open to participants now.
This study's planned enrollment of 1,296 is above the median of 110 across 1,796 interventional studies indexed under Psychological Well-Being.
Browse Psychological Well-Being studies →Uppsala University is the lead sponsor of 390 studies on the registry; 86 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Self Help Plus
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.
Behavioral: Self Help Plus · Behavioral: Interaction Competencies with Children - for Parents
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.
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.
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.
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.
Time frame: Baseline, 3 months post-intervention, and 12 months post-intervention
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 3 months post-intervention, and 12 months post-intervention
Emotion recognition task (facial and vocal expressions)
Children's ability to identify and interpret emotions will be measured using an emotion recognition task consisting of approximately 50 short video clips depicting facial and vocal expressions across nine emotions. Participants indicate the emotion and rate confidence in their judgment. Accuracy scores will be calculated, with higher scores reflecting better emotion recognition ability.
Time frame: Baseline and 12 months post-intervention
Executive functioning (Dimensional Change Card Sort, DCCS)
Children's cognitive flexibility and inhibitory control will be assessed using the Dimensional Change Card Sort (DCCS) task. Participants sort cards according to changing rules (e.g., by color or shape), measuring their ability to shift attention between tasks. Higher accuracy and faster reaction times indicate better executive functioning.
Time frame: Baseline and 12 months post-intervention
Theory of mind (false-belief tasks)
Children's theory of mind will be assessed using two standard false-belief tasks (surprise content and surprise outcome). These tasks evaluate the ability to understand that others may hold beliefs different from one's own. The proportion of correct responses indicates higher levels of theory of mind development.
Time frame: Baseline and 12 months post-intervention
Social preferences (incentivized experimental games)
Social preferences will be measured through an incentivized experimental dictator game slightly adapted from Benenson et al. (2007). The children are instructed to first select six stickers from a larger set of ten and then make a one-shot allocation decision, choosing how many stickers to keep for themselves and how many to give to an anonymous child living in the same village. The allocation is made privately by placing tokens into separate opaque bags for "keep" and "give," while the enumerator turns away. Children may give zero, some, or all tokens. This task is designed to capture basic prosocial sharing behavior in a developmentally appropriate manner.
Time frame: Baseline and 12 months post-intervention
Sibling relationship quality
Quality of the relationship between the two participating siblings, assessed using an adapted 11-item version of the Dunn Sibling Relationship Questionnaire. The scale measures warmth, intimacy, conflict, and rivalry on a 5-point scale (1 = never to 5 = always). Each child reports on their relationship with the sibling who is also enrolled in the study. Higher scores on warmth and intimacy reflect more positive relationships, while higher conflict and rivalry indicate relational strain.
Time frame: Baseline and 12 months post-intervention
Caregiver emotion recognition task (facial and vocal expressions)
Caregivers' ability to identify and interpret emotions will be measured using an emotion recognition task consisting of approximately 50 short video clips depicting facial and vocal expressions across nine emotions. Participants indicate the emotion and rate confidence in their judgment. Accuracy scores will be calculated, with higher scores reflecting better emotion recognition ability.
Time frame: Baseline and 12 months post-intervention
Intimate partner violence (DHS Domestic Violence Module)
Experiences of intimate partner violence among female caregivers will be assessed using the Domestic Violence Module from the Demographic and Health Surveys (DHS), adapted from the Conflict Tactics Scale. Items capture emotional, physical, and sexual violence and controlling behaviors. Higher frequency scores indicate greater exposure to violence.
Time frame: Baseline and 12 months post-intervention
Alcohol use (Alcohol Use Disorders Identification Test, AUDIT)
Alcohol consumption among male caregivers will be measured using the 10-item Alcohol Use Disorders Identification Test (AUDIT) developed by the World Health Organization. Items assess alcohol consumption, dependence symptoms, and related problems on a 0-4 scale, yielding a total score between 0 and 40. Higher scores indicate hazardous or harmful drinking.
Time frame: Baseline and 12 months post-intervention
Plan to share: 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.
Start is estimated for Mar 2026; primary completion for Jul 2027, 16 months later.
Of 1,259 non-industry interventional studies with no phase under Psychological Well-Being, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 34. This study's planned 16 months is close to that.
Counting every sponsor, half of 1,302 studies reached it within 16 months; a quarter within 7 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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