Mental Health Wellness 1NCT04082026
Early Adolescent Skills for Emotions Tanzania Pilot
A study testing Early Adolescent Skills for Emotions EASE) in people with Mental Health Wellness 1, run by International Rescue Committee at 1 site in United States.
Trial summary
The goal of this pilot is to test the World Health Organization (WHO) Early Adolescent Skills for Emotions intervention, a new psychological intervention. The pilot in Tanzania adapted the manual for young adolescent Burundian refugees in Tanzania (ages 10 - 14) with prolonged disabling distress living in communities… Read more about this study
- Who is it for?
- Ages 10 to 14 years
- Conditions the study is for
- Mental Health Wellness 1
- What is being tested?
- Early Adolescent Skills for Emotions EASE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2018to 1 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 10 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- a score of eight or more points on the Child Psychosocial Distress Screener (CPDS)
Who cannot join
- High suicide risk
- Severe impairment
- Lack of parental consent
Trial locations and contacts
1 site in 1 country.
United States1 site
International Rescue Committee
New York, New York, 10168
About this study
Official title: Towards an Evidence-based Scalable Psychological Intervention for Young Adolescents: Feasibility cRCT of Group Psychological Help for Young Burundian Refugee Adolescents in Tanzania.
The goal of this pilot is to test the World Health Organization (WHO) Early Adolescent Skills for Emotions intervention, a new psychological intervention. The pilot in Tanzania adapted the manual for young adolescent Burundian refugees in Tanzania (ages 10 - 14) with prolonged disabling distress living in communities affected by adversity. We conducted a formative study to adapt the EASE material, followed by small feasibility RCT (M=72) along with a process evaluation.
Read the detailed description
WHO is developing a set of scalable brief psychological programs: a new generation of shorter, less expensive and trans-diagnostic programs that can be delivered by non-specialized providers (e.g. without formal education or experience in mental health), to reduce common mental health symptoms and improve psychosocial functioning. In this pilot in Tanzania, the IRC, JHU and WHO seek to assess EASE, a much needed, brief psychological intervention developed specifically for young adolescents and their caregivers, and applicable in different humanitarian contexts.
The IRC, JHU and WHO, in collaboration with UNHCR, Muhimbili University of Health and Allied Sciences in Tanzania, and Village Health Works , adapted and contextualized the EASE intervention for Burundian refugee young adolescents in Tanzania. The adaptation had three steps:
First, the IRC conducted a desk review focusing on the cultural context for mental health research among Burundian refugees, covering local concepts, beliefs and practices associated with psychosocial support.
Second, the IRC conducted a formative qualitative study, consisting of 88 semi-structured qualitative interviews (free listing (n=61) and key informant interviews (n=25)), including with Burundian adolescent boys and girls (See Tables 1 \& 2 in Annex for breakdown of interview participants). This was followed by four focus group discussions (n=20) using cognitive interviewing techniques with adolescents and caregivers to seek feedback specifically on example intervention materials.
Third, the IRC and its partners used findings from the desk review and the qualitative study to inform an adaptation workshop in May 2018 held in Kibondo, Tanzania. For the adaptation workshop, the IRC convened the WHO, IRC mental health field staff, Village Health Works staff, and Dr Samuel Likindikoki from the Muhimbili University of Health and Allied Sciences. The adaptation workshop included a review of the data collected during the ethnographic study, as well as a mock run-through of the EASE materials, which allowed for an in-depth review of the intervention content.
The EASE pilot implementation and testing phase had eight main activities: 1) initial screening of adolescents for eligibility into the EASE program; 2) baseline data collection with the eligible participants and caregivers; 3) facilitator training; 4) development of a referral protocol to ensure adequate services for participants who experienced violence or were at high risk of suicide; 5) implementation of the EASE sessions; 6) implementation of the "Enhanced treatment as usual" sessions (our control condition, conducted at the same time as the EASE sessions); 7) endline data collection; and 8) process evaluation.
- Conditions
- Mental Health Wellness 1
- Being tested
- Early Adolescent Skills for Emotions EASE)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Adolescent Skills for Emotions EASE)Behavioural
Also called Enhanced Treatment as Usual (ETAU)
EASE is conducted in 7 weekly group sessions with adolescents. EASE sessions help adolescents:
- Identify their feelings and body reactions
- Practice breathing exercises
- Get active: Make a plan to positively change their actions
- Manage their problems
| Study group | Role | What they receive |
|---|---|---|
| Early Adolescent Skills for Emotions (EASE) | Experimental | EASE has four core features: Seven group sessions for young adolescents and three for their caregivers; Delivered by non-specialists; Trans-diagnostic: addressing depression, anxiety, distress, and other problems as defined by the young people themselves; and Designed for young people and their caregivers in low- and middle-income countries living in communities affected by adversity. Receives: Behavioral: Early Adolescent Skills for Emotions EASE) |
| Enhanced Treatment As Usual (ETAU) | Placebo comparator | The Enhanced Treatment as Usual (ETAU) consisted of a single psychoeducation individual session, jointly for eligible adolescents and their caregivers, that included information on: (i) the results of the screening; (ii) self-care strategies; and, (iii) seeking services from local health or community services offering psychosocial / mental health care support. Receives: Behavioral: Early Adolescent Skills for Emotions EASE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
African Youth Psychosocial Assessment
Adolescent psychological distress was assessed using the total problem score from the African Youth Psychosocial Assessment (AYPA), which consists of 33 items capturing internalizing symptoms, externalizing symptoms, and somatic complaints with a 4-point response scale (range 0-99). The AYPA also includes a subscale capturing prosocial behaviors (8 items, range 0-24). While we relied on the adolescent-reported AYPA as our primary outcome, we also included a caregiver-reported version of the AYPA to allow for comparison.
Measured: 2 months
Secondary outcomes (4)
Short Warwick-Edinburgh Mental Wellbeing Scale
Adolescent mental well-being was assessed with the 14-item Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS; 5-point response scale, range 0-28) (Tennant et al., 2007).
Measured: 2 months
Child Post Traumatic Stress Disorder (PTSD) Symptom Scale
Adolescent PTSD symptoms were assessed with the Child PTSD Symptom Scale (CPSS) (Foa, Johnson, Feeny, \& Treadwell, 2001). This 17-item measure uses a 4-point response scale to assess PTSD symptoms according to Diagnostic and Statistical Manual of Mental Disorders criteria (range 0-51).
Measured: 2 months
Child Trauma Questionnaire (CTQ)
Adolescent traumatic exposures were measured using a 15-item version of the Child Trauma Questionnaire (CTQ) that was adapted locally (5-point response scale, range 0-60) (Bernstein \& Fink, 1998; Charak, de Jong, Berckmoes, Ndayisaba, \& Reis, 2017).
Measured: 2 months
Adolescent Exposure to Violence
Adolescent exposure to violence was examined using a locally developed list of 33 dichotomous items (yes or no) that assessed lifetime experiences of violence perpetrated both by caregivers and non-caregivers (including emotional, physical, and sexual abuse). Follow-up questions to each item determined recency of violence (i.e., whether or not it had occurred within the past two months).
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start1 May 2018
- Primary completion1 Mar 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health Wellness 1Studies 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
- Model description
- The research study compared the EASE treatment (7 weekly sessions for adolescents and 3 for their caregivers) against an Enhanced Treatment as Usual (ETAU) consisting of a single psychoeducation individual session, jointly for eligible adolescents and their caregivers. ETAU included information on: (i) the results of the screening; (ii) self-care strategies; and, (iii) seeking services from local health or community services offering psychosocial / mental health care support.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Rescue Committee
- Sponsor type
- University, hospital or other
- Collaborators
- World Health Organization, Johns Hopkins University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04082026
- Sponsor's protocol ID
- CYPD 1.00.003
- Status last verified
- Aug 2019
- First submitted
- 29 Aug 2019
- Last updated
- 9 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Towards an Evidence-based Scalable Psychological Intervention for Young Adolescents: Feasibility cRCT of Group Psychological Help for Young Burundian Refugee Adolescents in Tanzania.
- ClinicalTrials.gov ID
- NCT04082026
- Acronym / sponsor ID
- CYPD 1.00.003
- Conditions
- Mental Health Wellness 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- International Rescue CommitteeUniversity, hospital or other
- Collaborators
- World Health Organization, Johns Hopkins University
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 9 Sep 2019 (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 pilot is to test the World Health Organization (WHO) Early Adolescent Skills for Emotions intervention, a new psychological intervention. The pilot in Tanzania adapted the manual for young adolescent Burundian refugees in Tanzania (ages 10 - 14) with prolonged disabling distress living in communities affected by adversity. We conducted a formative study to adapt the EASE material, followed by small feasibility RCT (M=72) along with a process evaluation.
Detailed description
WHO is developing a set of scalable brief psychological programs: a new generation of shorter, less expensive and trans-diagnostic programs that can be delivered by non-specialized providers (e.g. without formal education or experience in mental health), to reduce common mental health symptoms and improve psychosocial functioning. In this pilot in Tanzania, the IRC, JHU and WHO seek to assess EASE, a much needed, brief psychological intervention developed specifically for young adolescents and their caregivers, and applicable in different humanitarian contexts.
The IRC, JHU and WHO, in collaboration with UNHCR, Muhimbili University of Health and Allied Sciences in Tanzania, and Village Health Works , adapted and contextualized the EASE intervention for Burundian refugee young adolescents in Tanzania. The adaptation had three steps:
First, the IRC conducted a desk review focusing on the cultural context for mental health research among Burundian refugees, covering local concepts, beliefs and practices associated with psychosocial support.
Second, the IRC conducted a formative qualitative study, consisting of 88 semi-structured qualitative interviews (free listing (n=61) and key informant interviews (n=25)), including with Burundian adolescent boys and girls (See Tables 1 \& 2 in Annex for breakdown of interview participants). This was followed by four focus group discussions (n=20) using cognitive interviewing techniques with adolescents and caregivers to seek feedback specifically on example intervention materials.
Third, the IRC and its partners used findings from the desk review and the qualitative study to inform an adaptation workshop in May 2018 held in Kibondo, Tanzania. For the adaptation workshop, the IRC convened the WHO, IRC mental health field staff, Village Health Works staff, and Dr Samuel Likindikoki from the Muhimbili University of Health and Allied Sciences. The adaptation workshop included a review of the data collected during the ethnographic study, as well as a mock run-through of the EASE materials, which allowed for an in-depth review of the intervention content.
The EASE pilot implementation and testing phase had eight main activities: 1) initial screening of adolescents for eligibility into the EASE program; 2) baseline data collection with the eligible participants and caregivers; 3) facilitator training; 4) development of a referral protocol to ensure adequate services for participants who experienced violence or were at high risk of suicide; 5) implementation of the EASE sessions; 6) implementation of the "Enhanced treatment as usual" sessions (our control condition, conducted at the same time as the EASE sessions); 7) endline data collection; and 8) process evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The research study compared the EASE treatment (7 weekly sessions for adolescents and 3 for their caregivers) against an Enhanced Treatment as Usual (ETAU) consisting of a single psychoeducation individual session, jointly for eligible adolescents and their caregivers. ETAU included information on: (i) the results of the screening; (ii) self-care strategies; and, (iii) seeking services from local health or community services offering psychosocial / mental health care support.
| Arm | Type | Receives |
|---|---|---|
| Early Adolescent Skills for Emotions (EASE) | Experimental | Behavioral: Early Adolescent Skills for Emotions EASE)EASE has four core features: Seven group sessions for young adolescents and three for their caregivers; Delivered by non-specialists; Trans-diagnostic: addressing depression, anxiety, distress, and other problems as defined by the young people themselves; and Designed for young people and their caregivers in low- and middle-income countries living in communities affected by adversity. |
| Enhanced Treatment As Usual (ETAU) | Placebo comparator | Behavioral: Early Adolescent Skills for Emotions EASE)The Enhanced Treatment as Usual (ETAU) consisted of a single psychoeducation individual session, jointly for eligible adolescents and their caregivers, that included information on: (i) the results of the screening; (ii) self-care strategies; and, (iii) seeking services from local health or community services offering psychosocial / mental health care support. |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- a score of eight or more points on the Child Psychosocial Distress Screener (CPDS)
Key exclusion criteria (3 listed)
- High suicide risk
- Severe impairment
- Lack of parental consent
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 |
|---|---|---|
| Early Adolescent Skills for Emotions EASE)Also: Enhanced Treatment as Usual (ETAU)EASE is conducted in 7 weekly group sessions with adolescents. EASE sessions help adolescents: * Identify their feelings and body reactions * Practice breathing exercises * Get active: Make a plan to positively change their actions * Manage their problems | Behavioural | Early Adolescent Skills for Emotions (EASE), Enhanced Treatment As Usual (ETAU) |
Primary outcome
African Youth Psychosocial Assessment
Time frame: 2 months
Adolescent psychological distress was assessed using the total problem score from the African Youth Psychosocial Assessment (AYPA), which consists of 33 items capturing internalizing symptoms, externalizing symptoms, and somatic complaints with a 4-point response scale (range 0-99). The AYPA also includes a subscale capturing prosocial behaviors (8 items, range 0-24). While we relied on the adolescent-reported AYPA as our primary outcome, we also included a caregiver-reported version of the AYPA to allow for comparison.
4 secondary outcomes
Short Warwick-Edinburgh Mental Wellbeing Scale
Time frame: 2 months
Child Post Traumatic Stress Disorder (PTSD) Symptom Scale
Time frame: 2 months
Child Trauma Questionnaire (CTQ)
Time frame: 2 months
Adolescent Exposure to Violence
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2019.
- Individual participant dataSharing planned: No
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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 Early Adolescent Skills for Emotions EASE) in people with Mental Health Wellness 1, run by International Rescue Committee at 1 site in United States.
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 1 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: finished, as of the sponsor's last update on 9 Sep 2019. 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 United States. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
African Youth Psychosocial Assessment (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Sep 2019.