Mental HealthSEEDNCT07062341
Self-Help Plus to Enhance Early Development: A Cluster-Randomized Controlled Trial of Maternal Mental Health, Child Cognitive Abilities, and Socio-Behavioral Skills Among Refugee Mothers and Their Preschool-Aged Children in Rhino Camp, Uganda
A study testing Self-Help Plus (SH+) in people with Mental Health and Psychological Distress, run by Uppsala University at 1 site in Uganda.
Trial summary
This study evaluates whether the group-based mental health program Self-Help Plus (SH+) can improve the mental health, wellbeing, and functioning of refugee mothers and their preschool-aged children living in Rhino Refugee Settlement (Rhino Camp), Uganda. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Mental Health, Psychological Distress, Child Wellbeing
- What is being tested?
- Self-Help Plus (SH+)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 725 participants
- Where
- 1 siteUganda
- Study dates
- 13 Oct 2025to Feb 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older
- Able to speak and understand Juba Arabic
- Mother of a child aged 3-4 years at the time of enrollment
- Not planning to move away from the study area (Rhino Camp) within the next year
- At least moderate psychological distress, defined as a score ≥5 on the Kessler-6 (K6) screening scale
- Aged 3-4 years at the time of baseline enrollment
Show all 9Show fewer
- Resides with the enrolled mother in one of the selected villages in Rhino Camp
- The child's mother meets all eligibility criteria and is enrolled in the trial
- Provides assent
Who cannot join
- Currently participating in another structured mental health intervention
- Prior participation in SH+, or familiarity with its content
- Imminent risk of suicide, assessed using the suicidality subscale of the Mini International Neuropsychiatric Interview (MINI)
- Observable signs of psychosis, manic behavior, or intellectual disability that would preclude meaningful participation (as judged by trained assessors)
- Known cognitive impairment or developmental delay that would prevent participation in age-appropriate assessments, based on maternal report and enumerator judgment
- Physical health condition that would prevent safe participation at the time of data collection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Building Resilience in the Aftermath of Displacement: The Intergenerational Effects of a Randomized Mental Health Intervention for Refugee Families
This study evaluates whether the group-based mental health program Self-Help Plus (SH+) can improve the mental health, wellbeing, and functioning of refugee mothers and their preschool-aged children living in Rhino Refugee Settlement (Rhino Camp), Uganda. SH+ is a stress management course developed by the World Health Organization for people affected by adversity. A previous study in this setting found that SH+ improved mental health outcomes among South Sudanese refugee women (Tol et al., 2020). However, it remains unclear whether these effects are sustained over time and whether improvements in maternal mental health also lead to positive outcomes for children.
This study asks two main research questions:
Read more
- Does SH+ lead to lasting improvements in maternal mental health one year after the intervention?
- Does SH+ administered to mothers improve children's wellbeing?
The trial's main focus is on two outcomes assessed 12 months post-intervention: the primary outcome is maternal psychological distress (Kessler-6; K6), and the key secondary outcome is children's psychosocial wellbeing (Kiddy-KINDLR; parent report).
To answer these questions, this study will employ a cluster-randomized controlled trial with two arms. Villages are randomized to receive either SH+ plus Enhanced Usual Care (EUC) or EUC only (active control). Outcomes are assessed at baseline, 3 months post-intervention, and 12 months post-intervention (the primary endpoint).
In addition to the primary outcome and key secondary outcome, the study includes a broader set of secondary outcomes capturing maternal mental health and functioning, parenting, and child wellbeing. The study also collects prespecified exploratory outcomes, including socio-behavioral skills of mothers and children measured using incentivized economic games, as well as child cognitive development.
The study uses caregiver reports, direct child assessments, and incentivized tasks to measure outcomes. By integrating mental health, developmental, and behavioral measures, this study examines whether SH+ produces lasting mental health benefits and whether improvements in maternal mental health translate into positive outcomes for preschool-aged children in an adverse humanitarian setting.
Read the detailed description
This cluster-randomized controlled trial (cRCT) evaluates the sustained and intergenerational impacts of the World Health Organization's Self-Help Plus (SH+) program among refugee mothers and their preschool-aged children in Rhino Refugee Settlement, Uganda. SH+ is a brief, low-intensity, group-based stress management intervention designed for humanitarian settings. Grounded in Acceptance and Commitment Therapy, SH+ is facilitated by trained non-specialist peers from the local refugee community and consists of five weekly audio-guided group sessions supported by a self-help book.
The trial enrolls 720 mother-child dyads across 24 village clusters randomized 1:1 to one of two arms: (i) SH+ plus Enhanced Usual Care (EUC), or (ii) EUC only (active control). EUC consists of a brief psychoeducation session and referral information for available mental health resources. Assessments are conducted at baseline, 3 months post-intervention, and 12 months post-intervention (primary endpoint). Child cognitive skills and the socio-behavioral skills of mothers and children are assessed only at baseline and 12 months. Cluster randomization at the village level is used because SH+ is delivered in group sessions within villages and to minimize contamination.
This trial is designed around a prespecified outcome hierarchy that prioritizes a single primary outcome and a single key secondary outcome at the 12-month endpoint. The primary outcome is maternal psychological distress (Kessler-6; K6) at 12 months. The key secondary outcome is child psychosocial wellbeing at 12 months, measured with the parent-report Kiddy-KINDLR. Analyses of this outcome follow those of the primary outcome in a prespecified sequence to preserve the trial's main inferential focus.
In addition, the study includes secondary outcomes capturing broader maternal mental health and functioning, parenting practices, and child wellbeing and functioning. The study also collects prespecified exploratory outcomes, including socio-behavioral skills of mothers and children measured using incentivized economic games, and child cognitive development.
Outcomes are assessed through caregiver interviews, direct child assessments, and age-adapted incentivized tasks. The trial provides a rigorous test of whether a scalable maternal mental health intervention can produce durable benefits for mothers, and whether improvements in maternal mental health translate into benefits for young children in a protracted displacement setting.
- Being tested
- Self-Help Plus (SH+), Enhanced Usual Care (EUC)
- Keywords
- self-help plus, psychological distress, mental health, child development, economic preferences, cognitive development, refugee, cluster randomized controlled trial
- 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 Plus (SH+)Behavioural
SH+ is a low-intensity, scalable stress management intervention developed by the World Health Organization. It is designed for delivery in humanitarian settings by non-specialist facilitators. The intervention consists of five 2-hour group sessions delivered via pre-recorded audio, supported by an illustrated guidebook adapted to the local cultural and linguistic context (Juba Arabic). Sessions teach mindfulness, acceptance, and value-driven behavior based on principles from Acceptance and Commitment Therapy. In this study, SH+ is delivered to 12 groups of up to 30 South Sudanese refugee mothers in Rhino Camp, Uganda, by trained lay peers from the refugee community. The intervention is paired with Enhanced Usual Care.
Enhanced Usual Care (EUC)Behavioural
EUC consists of a one-time, brief psychoeducation session lasting approximately 15 minutes, delivered individually by a trained lay provider under clinical supervision. The session focuses on helping participants understand and manage common symptoms of psychological distress-particularly local expressions such as "overthinking"-and introduces simple self-management strategies. Participants are also provided with information about available mental health and psychosocial support services within Rhino Camp, including referral pathways to professional care and community-based resources. This intervention serves as a minimal yet contextually relevant comparator that controls for attention and information exposure while remaining distinct from structured therapeutic interventions like SH+.
| Study group | Role | What they receive |
|---|---|---|
| EUC | Active comparator | Participants in this arm receive a brief, individual psychoeducation session lasting approximately 15 minutes, delivered by a trained lay provider under the supervision of a clinical psychologist. The session provides simple information on managing stress and rumination (locally referred to as "overthinking"), a prevalent concern in the refugee population. Participants are also informed about available mental health services within Rhino Camp, including community-based support structures and referral pathways to professional care. The EUC condition is designed to offer minimal, non-specialist mental health support while serving as a credible comparator for the SH+ intervention. Receives: Behavioral: Enhanced Usual Care (EUC) |
| SH+EUC | Experimental | Participating mothers in this arm receive the full SH+ intervention in addition to Enhanced Usual Care. SH+ is a low-intensity, group-based stress management program developed by the World Health Organization. It is delivered over five sessions using pre-recorded audio content and a locally adapted illustrated guidebook, facilitated by trained non-specialists from the refugee community. The intervention aims to improve psychological wellbeing by teaching acceptance, mindfulness, and value-based action. As in the EUC arm, participants also receive a brief psychoeducation session and information about available mental health services. Receives: Behavioral: Self-Help Plus (SH+); Behavioral: Enhanced Usual Care (EUC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological Distress
Mothers' psychological distress is assessed using the Kessler Psychological Distress Scale (K6), a 6-item self-report questionnaire that captures symptoms of anxiety and depression experienced in the past 30 days. Each item is scored from 0 (none of the time) to 4 (all of the time), yielding a total score ranging from 0 to 24. Higher scores indicate greater psychological distress. The outcome reflects the change in mean K6 scores from baseline to 12 months post-intervention.
Measured: Baseline and 12 months post-intervention
Secondary outcomes (12)
Key secondary outcome: Child psychosocial wellbeing (parent-report)
Child psychosocial wellbeing is assessed using the Kiddy-KINDL Parent Version, a validated 24-item caregiver-reported instrument designed to capture health-related quality of life in children aged 3-6 years. Each item is scored on a 5-point Likert scale, and scores are transformed to a total score ranging from 0 to 100, with higher scores indicating better wellbeing. The outcome represents the change in mean Kiddy-KINDL scores from baseline to 12 months post-intervention, based on maternal reports collected by trained enumerators in the caregiver's preferred language.
Measured: Baseline and 12 months post-intervention
Depression
Mothers' depressive symptoms are assessed using the 9-item Patient Health Questionnaire (PHQ-9). Scores range from 0 to 27, with higher scores indicating more severe depressive symptoms. Change from baseline to 12 months is measured through self-report.
Measured: Baseline and 12 months post-intervention
Posttraumatic Stress
Mothers' posttraumatic stress will be assessed using the PTSD Checklist - Civilian Version (PCL-C). Scores range from 6 to 30, with higher scores indicating more severe PTSD symptoms.
Measured: Baseline and 12 months post-intervention
Anxiety
Mothers' anxiety symptoms are assessed using the 7-item Generalized Anxiety Disorder scale (GAD-7). Scores range from 0 to 21, with higher scores indicating more severe anxiety.
Measured: Baseline and 12 months post-intervention
Perceived Stress
Mothers' perceived stress is assessed using the 4-item Perceived Stress Scale (PSS-4). Total scores range from 0 to 16, with higher scores reflecting greater perceived stress.
Measured: Baseline and 12 months post-intervention
Positive Parenting
Positive parenting will be measured using the Positive Parenting subscale of the Alabama Parenting Questionnaire (APQ). Higher scores indicate more frequent positive parenting practices.
Measured: Baseline and 12 months post-intervention
Disciplinary Practices
Harsh disciplinary practices will be ssessed using the UNICEF MICS6 11-item Discipline Module. Higher scores reflect use of more types of disciplinary actions.
Measured: Baseline and 12 months post-intervention
Subjective Wellbeing
Mothers' subjective wellbeing is assessed using the 5-item World Health Organization Well-Being Index (WHO-5). It contains five questions that assess positive mood, vitality, and general interests. The responses are scored on a scale from 0 (at no time) to 5 (all of the time), and the total score is then multiplied by 4 to give a score range from 0 to 100, with higher scores indicating greater wellbeing.
Measured: Baseline and 12 months post-intervention
Functional Impairment
Mothers' functional impairment is assessed using the 15-item WHO Disability Assessment Schedule (WHODAS-II). Scores reflect levels of functional impairment across several domains. Higher scores indicate greater impairment.
Measured: Baseline and 12 months post-intervention
Psychological Flexibility
Mothers' psychological flexibility will be measured using the 7-item Acceptance and Action Questionnaire-II (AAQ-II). Scores range from 7 to 49, with higher scores reflecting greater psychological inflexibility.
Measured: Baseline and 12 months post-intervention
Child Emotional and Behavioral Problems
Children's emotional and behavioral problems will be assessed using the 17-item Pediatric Symptom Checklist (PSC-17), completed by caregivers. Total scores range from 0 to 34, with higher scores indicating more psychosocial difficulties.
Measured: Baseline and 12 months post-intervention
Child Psychosocial Wellbeing (child self-report)
Children's psychosocial wellbeing will also be assessed using the self-report version of the Kiddy-KINDL. Scores range from 0 to 100, with higher scores indicating better psychosocial wellbeing.
Measured: Baseline 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 posted14 Jul 2025
- Study start13 Oct 2025
- Primary completionFeb 2027 (estimated)
- Study completionFeb 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
- 725 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Vivo international e.V., Kabale University, Bielefeld University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07062341
- Sponsor's protocol ID
- P22-0514
- Other IDs
- P22-0514
- Acronym
- SEED
- Status last verified
- Feb 2026
- First submitted
- 2 Jul 2025
- Last updated
- 12 Feb 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 women and preschool-aged 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
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 31981556Vassiliou PTB, Ainamani HE, Doring S, Gredeback G, Leku MR, Peltonen K, Scharpf F, Sen U, Sutter M, Walsh JI, Hecker T, Hall J. Self-Help Plus for refugee mothers in Rhino Refugee Settlement, Uganda (SEED): study protocol for a cluster-randomized controlled trial assessing intergenerational effects on preschool-aged children. Trials. 2026 Feb 17;27(1):173. doi: 10.1186/s13063-026-09546-1.
PubMed 41699624
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building Resilience in the Aftermath of Displacement: The Intergenerational Effects of a Randomized Mental Health Intervention for Refugee Families
- ClinicalTrials.gov ID
- NCT07062341
- Acronym / sponsor ID
- SEED / P22-0514
- Keywords
- self-help plus, psychological distress, mental health, child development, economic preferences, cognitive development, refugee, cluster randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 725 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Vivo international e.V., Kabale University, Bielefeld University
- Study start
- 13 Oct 2025 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 14 Jul 2025 (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.
This study evaluates whether the group-based mental health program Self-Help Plus (SH+) can improve the mental health, wellbeing, and functioning of refugee mothers and their preschool-aged children living in Rhino Refugee Settlement (Rhino Camp), Uganda. SH+ is a stress management course developed by the World Health Organization for people affected by adversity. A previous study in this setting found that SH+ improved mental health outcomes among South Sudanese refugee women (Tol et al., 2020). However, it remains unclear whether these effects are sustained over time and whether improvements in maternal mental health also lead to positive outcomes for children.
This study asks two main research questions:
- Does SH+ lead to lasting improvements in maternal mental health one year after the intervention?
- Does SH+ administered to mothers improve children's wellbeing?
The trial's main focus is on two outcomes assessed 12 months post-intervention: the primary outcome is maternal psychological distress (Kessler-6; K6), and the key secondary outcome is children's psychosocial wellbeing (Kiddy-KINDLR; parent report).
To answer these questions, this study will employ a cluster-randomized controlled trial with two arms. Villages are randomized to receive either SH+ plus Enhanced Usual Care (EUC) or EUC only (active control). Outcomes are assessed at baseline, 3 months post-intervention, and 12 months post-intervention (the primary endpoint).
In addition to the primary outcome and key secondary outcome, the study includes a broader set of secondary outcomes capturing maternal mental health and functioning, parenting, and child wellbeing. The study also collects prespecified exploratory outcomes, including socio-behavioral skills of mothers and children measured using incentivized economic games, as well as child cognitive development.
The study uses caregiver reports, direct child assessments, and incentivized tasks to measure outcomes. By integrating mental health, developmental, and behavioral measures, this study examines whether SH+ produces lasting mental health benefits and whether improvements in maternal mental health translate into positive outcomes for preschool-aged children in an adverse humanitarian setting.
Detailed description
This cluster-randomized controlled trial (cRCT) evaluates the sustained and intergenerational impacts of the World Health Organization's Self-Help Plus (SH+) program among refugee mothers and their preschool-aged children in Rhino Refugee Settlement, Uganda. SH+ is a brief, low-intensity, group-based stress management intervention designed for humanitarian settings. Grounded in Acceptance and Commitment Therapy, SH+ is facilitated by trained non-specialist peers from the local refugee community and consists of five weekly audio-guided group sessions supported by a self-help book.
The trial enrolls 720 mother-child dyads across 24 village clusters randomized 1:1 to one of two arms: (i) SH+ plus Enhanced Usual Care (EUC), or (ii) EUC only (active control). EUC consists of a brief psychoeducation session and referral information for available mental health resources. Assessments are conducted at baseline, 3 months post-intervention, and 12 months post-intervention (primary endpoint). Child cognitive skills and the socio-behavioral skills of mothers and children are assessed only at baseline and 12 months. Cluster randomization at the village level is used because SH+ is delivered in group sessions within villages and to minimize contamination.
This trial is designed around a prespecified outcome hierarchy that prioritizes a single primary outcome and a single key secondary outcome at the 12-month endpoint. The primary outcome is maternal psychological distress (Kessler-6; K6) at 12 months. The key secondary outcome is child psychosocial wellbeing at 12 months, measured with the parent-report Kiddy-KINDLR. Analyses of this outcome follow those of the primary outcome in a prespecified sequence to preserve the trial's main inferential focus.
In addition, the study includes secondary outcomes capturing broader maternal mental health and functioning, parenting practices, and child wellbeing and functioning. The study also collects prespecified exploratory outcomes, including socio-behavioral skills of mothers and children measured using incentivized economic games, and child cognitive development.
Outcomes are assessed through caregiver interviews, direct child assessments, and age-adapted incentivized tasks. The trial provides a rigorous test of whether a scalable maternal mental health intervention can produce durable benefits for mothers, and whether improvements in maternal mental health translate into benefits for young children in a protracted displacement setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EUC | Active comparator | Behavioral: Enhanced Usual Care (EUC)Participants in this arm receive a brief, individual psychoeducation session lasting approximately 15 minutes, delivered by a trained lay provider under the supervision of a clinical psychologist. The session provides simple information on managing stress and rumination (locally referred to as "overthinking"), a prevalent concern in the refugee population. Participants are also informed about available mental health services within Rhino Camp, including community-based support structures and referral pathways to professional care. The EUC condition is designed to offer minimal, non-specialist mental health support while serving as a credible comparator for the SH+ intervention. |
| SH+EUC | Experimental | Behavioral: Self-Help Plus (SH+), Behavioral: Enhanced Usual Care (EUC)Participating mothers in this arm receive the full SH+ intervention in addition to Enhanced Usual Care. SH+ is a low-intensity, group-based stress management program developed by the World Health Organization. It is delivered over five sessions using pre-recorded audio content and a locally adapted illustrated guidebook, facilitated by trained non-specialists from the refugee community. The intervention aims to improve psychological wellbeing by teaching acceptance, mindfulness, and value-based action. As in the EUC arm, participants also receive a brief psychoeducation session and information about available mental health services. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Aged 18 years or older
- Able to speak and understand Juba Arabic
- Mother of a child aged 3-4 years at the time of enrollment
- Not planning to move away from the study area (Rhino Camp) within the next year
- At least moderate psychological distress, defined as a score ≥5 on the Kessler-6 (K6) screening scale
Key exclusion criteria (6 listed)
- Currently participating in another structured mental health intervention
- Prior participation in SH+, or familiarity with its content
- Imminent risk of suicide, assessed using the suicidality subscale of the Mini International Neuropsychiatric Interview (MINI)
- Observable signs of psychosis, manic behavior, or intellectual disability that would preclude meaningful participation (as judged by trained assessors)
- Known cognitive impairment or developmental delay that would prevent participation in age-appropriate assessments, based on maternal report and enumerator judgment
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 Plus (SH+)SH+ is a low-intensity, scalable stress management intervention developed by the World Health Organization. It is designed for delivery in humanitarian settings by non-specialist facilitators. The intervention consists of five 2-hour group sessions delivered via pre-recorded audio, supported by an illustrated guidebook adapted to the local cultural and linguistic context (Juba Arabic). Sessions teach mindfulness, acceptance, and value-driven behavior based on principles from Acceptance and Commitment Therapy. In this study, SH+ is delivered to 12 groups of up to 30 South Sudanese refugee mothers in Rhino Camp, Uganda, by trained lay peers from the refugee community. The intervention is paired with Enhanced Usual Care. | Behavioural | SH+EUC |
| Enhanced Usual Care (EUC)EUC consists of a one-time, brief psychoeducation session lasting approximately 15 minutes, delivered individually by a trained lay provider under clinical supervision. The session focuses on helping participants understand and manage common symptoms of psychological distress-particularly local expressions such as "overthinking"-and introduces simple self-management strategies. Participants are also provided with information about available mental health and psychosocial support services within Rhino Camp, including referral pathways to professional care and community-based resources. This intervention serves as a minimal yet contextually relevant comparator that controls for attention and information exposure while remaining distinct from structured therapeutic interventions like SH+. | Behavioural | EUC, SH+EUC |
Primary outcome
Psychological Distress
Time frame: Baseline and 12 months post-intervention
Mothers' psychological distress is assessed using the Kessler Psychological Distress Scale (K6), a 6-item self-report questionnaire that captures symptoms of anxiety and depression experienced in the past 30 days. Each item is scored from 0 (none of the time) to 4 (all of the time), yielding a total score ranging from 0 to 24. Higher scores indicate greater psychological distress. The outcome reflects the change in mean K6 scores from baseline to 12 months post-intervention.
12 secondary outcomes
Key secondary outcome: Child psychosocial wellbeing (parent-report)
Time frame: Baseline and 12 months post-intervention
Depression
Time frame: Baseline and 12 months post-intervention
Posttraumatic Stress
Time frame: Baseline and 12 months post-intervention
Anxiety
Time frame: Baseline and 12 months post-intervention
Perceived Stress
Time frame: Baseline and 12 months post-intervention
Positive Parenting
Time frame: Baseline and 12 months post-intervention
Disciplinary Practices
Time frame: Baseline and 12 months post-intervention
Subjective Wellbeing
Time frame: Baseline and 12 months post-intervention
Functional Impairment
Time frame: Baseline and 12 months post-intervention
Psychological Flexibility
Time frame: Baseline and 12 months post-intervention
Child Emotional and Behavioral Problems
Time frame: Baseline and 12 months post-intervention
Child Psychosocial Wellbeing (child self-report)
Time frame: Baseline 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 12 Feb 2026.
- 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.
- Derived from this study: PubMed 41699624Vassiliou PTB, Ainamani HE, Doring S, Gredeback G, Leku MR, Peltonen K, Scharpf F, Sen U, Sutter M, Walsh JI, Hecker T, Hall J. Self-Help Plus for refugee mothers in Rhino Refugee Settlement, Uganda (SEED): study protocol for a cluster-randomized controlled trial assessing intergenerational effects on preschool-aged children. Trials. 2026 Feb 17;27(1):173. doi: 10.1186/s13063-026-09546-1.
- Individual participant dataSharing planned: No. Due to the sensitive nature of the data and the vulnerability of the study population, including refugee women and preschool-aged 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.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 (SH+) in people with Mental Health and Psychological Distress, run by Uppsala University at 1 site in Uganda.
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 9 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological Distress (time frame: Baseline 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 NCT07062341, 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 12 Feb 2026.