Post-Traumatic Stress Disorder in ChildrenNCT02226393
Evaluating Effectiveness of Dyadic Prolonged Exposure on 2-4 Years Old vs. Toddler-parent Focused Treatment
A study testing Prolonged exposure and Child-parent Play Therapy in people with Post-Traumatic Stress Disorder in Children, run by Association for Children at Risk at 2 sites in Israel.
Trial summary
Traumatic events have potentially debilitating long-lasting effects on the child's normal development and, therefore, should be effectively treated. Prolonged Exposure (PE) therapy has been found to be effective in reducing posttraumatic stress disorder symptoms in adults and in adolescents. Read more about this study
- Who is it for?
- Ages 18 to 66 months
- Conditions the study is for
- Post-Traumatic Stress Disorder in Children
- What is being tested?
- Prolonged exposure and Child-parent Play Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesIsrael
- Study dates
- Oct 2014to Sep 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 18 to 66 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Hebrew speaking toddlers with PTSD related to traumatic experience that occured at least 1 month prior to the study enrollment
- Toddlers whose parents are living together
Who cannot join
- Toddlers which are still dealing with an active life threatening illness and are hence going through medical procedures.
- Toddlers with intelectual developmental disorder
- Toddlers with an active psychosis
- Toddlers with blindness or deafness
- Toddlers who are currently taking psychotropic medication
- Toddlers and parents that receive psycotherapy outside of the study for their PTSD symptoms
- Toddlers diagnozed with autism spectrum disorder
- Toddlers who were exposed to domestic or sexual violence
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Rabin medical center
Petah Tikva
Association for Children at Risk's Cohen Harris Resilience Center
Tel Aviv
About this study
Official title: Evaluating Effectiveness of Dyadic Prolonged Exposure Treatment on 2-4 Years Old vs. Toddler-parent Focused Treatment
Traumatic events have potentially debilitating long-lasting effects on the child's normal development and, therefore, should be effectively treated. Prolonged Exposure (PE) therapy has been found to be effective in reducing posttraumatic stress disorder symptoms in adults and in adolescents. It has not yet been tested in toddlers.
The purpose of this study is to examine the treatment efficacy of 2 methods of treatment for toddlers with PTSD and their parents. A randomized control trial could examine the efficacy of PE versus dyadic play therapy (TP-CT). Exploration of these questions under more rigorous conditions would help broaden our knowledge about developmentally sensitive treatment tools for this age group.
Read more
Our research hypotheses are:
- PE would more effective than TP-CT in reducing post-traumatic symptoms in toddlers.
- PE would more effective than TP-CT in reducing post-traumatic symptoms of the toddlers' parents.
- These results will be preserved in a follow-up of 3-6 months post treatment. Following psychiatric assessment, 100 toddlers will be randomly assigned to PE and TP-CT (50 participants in each group).
Read the detailed description
Beyond what was detailed in the previous section of the brief summary, it should be noted that the toddlers will be assessed and treated at least 1 month post-trauma and at least 1 month after discharge from hospital in order to avoid acute reaction either to the traumatic event or to the medical procedures during their hospitalization and adjustment problems.
- Being tested
- Prolonged exposure, Child-parent Play Therapy
- Keywords
- Toddlers; Preschoolers; PTSD
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolonged exposureBehavioural
The PE treatment includes 12-15 60 minutes' sessions. The 2 main components of the treatment are psychoeducation about common reactions to trauma and in-vivo exposures (gradual exposure to trauma related situations and objects) and repeated recounting of the traumatic memory, Trauma memory recounting and in-vivo exposures are conducted during several successive sessions so the child learns that the exposures themselves pose no real harm to him, indicating that when one confronts what one is afraid of it becomes easier to manage.
Child-parent Play TherapyBehavioural
Is consisted of 12-15 weekly 60 minute sessions of parent-child centered therapy it focus on establishing a trusting, empowering, and validating therapeutic relationship. Participants are allowed to choose when, how, and whether or not to address their trauma memory. Therapists provide active listening, empathy,and encouragement to talk about feelings and express belief in the participants ability to cope. In sessions 4 and 8, participants are asked how they feel about their trauma. With this exception, participants direct the sessions.
| Study group | Role | What they receive |
|---|---|---|
| Prolonged exposure | Experimental | See intervention description Receives: Behavioral: Prolonged exposure |
| Child-parent Play Therapy | Active comparator | see intervention description Receives: Behavioral: Child-parent Play Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in post traumatic symptoms: clinical assessment and Young child ptsd checklist (YCPC, Scheeringa & Haslett, 2010).
Change from baseline in post traumatic symptoms will be assessed using the Classification of Mental Health and Developmental Disorders of Infancy and Early Childhood) and the Young Child PTSD Checklist (YCPC, Scheeringa \& Haslett, 2010). The YCPC assesses probable diagnosis formed the basis for the new DSM-5 disorder for posttraumatic stress disorder for children 6 years and younger.
Measured: Parents' pre-treatment, post treatment and follow-up 3,6,12 months post treatment
Secondary outcomes (4)
Beck Depression Inventory (BDI)
A self-report questionnaire for depression among adults
Measured: Parents' pre-treatment, post treatment (after 12-15 sessions) and follow-up 3-6 months post treatment
The Posttraumatic Stress Symptom Scale-Self report (PSS-SR; Foa, Riggs, Dancu & Rothbaum, 1993)
A self report questionnaire for the assessment of PTSD symptoms among adults
Measured: Parents' pre-treatment, during treatment (every 2 sessions), post treatment (after 12-15 sessions) and follow-up 3-6 months post treatment
Posttraumatic Stress Cognitions Inventory (PTCI)
A self report questionnaire assessing post traumatic beliefs in adults
Measured: Parents' pre-treatment, post treatment (after 12-15 sessions) and follow-up 3-6 months post treatment
Parenting Sense of Competence Scale )PSOC; Gibaud -Wallstton & Wandersman, 1978)
The Parenting Sense of Competency Scale (PSOC) was developed by Gibaud-Wallston as part of her PhD dissertation and presented at the American Psychological Association by Gibaud-Wallston and Wandersman in 1978. The PSOC is a 17 item scale, with 2 subscales. Each item is rated on a 6 point Likert scale anchored by 1 = "Strongly Disagree" and 6 = "Strongly Agree".
Measured: Parents' pre-treatment, post treatment (after 12-15 sessions) and follow-up 3-6 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2014 (estimated)
- Study startOct 2014
- Primary completionSep 2019
- Study completionSep 2019
Why it stopped: Recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Traumatic Stress Disorder in ChildrenStudies 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
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association for Children at Risk
- Sponsor type
- University, hospital or other
- Collaborators
- Geha Mental Health Center
- Responsible party
- Sponsor
- Investigators
- Orit Krispin, Phd, Principal investigator, Schneider Children's Medical Center, IsraelLilach Rachamim, Phd, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02226393
- Sponsor's protocol ID
- RMC147804ctil
- Status last verified
- Feb 2020
- First submitted
- 29 Jul 2014
- Last updated
- 11 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Effectiveness of Dyadic Prolonged Exposure Treatment on 2-4 Years Old vs. Toddler-parent Focused Treatment
- ClinicalTrials.gov ID
- NCT02226393
- Acronym / sponsor ID
- RMC147804ctil
- Keywords
- Toddlers; Preschoolers; PTSD
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Association for Children at RiskUniversity, hospital or other
- Collaborators
- Geha Mental Health Center
- Study start
- Oct 2014
- Primary completion
- Sep 2019 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 27 Aug 2014 (estimated)
- 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.
Traumatic events have potentially debilitating long-lasting effects on the child's normal development and, therefore, should be effectively treated. Prolonged Exposure (PE) therapy has been found to be effective in reducing posttraumatic stress disorder symptoms in adults and in adolescents. It has not yet been tested in toddlers.
The purpose of this study is to examine the treatment efficacy of 2 methods of treatment for toddlers with PTSD and their parents. A randomized control trial could examine the efficacy of PE versus dyadic play therapy (TP-CT). Exploration of these questions under more rigorous conditions would help broaden our knowledge about developmentally sensitive treatment tools for this age group.
Our research hypotheses are:
- PE would more effective than TP-CT in reducing post-traumatic symptoms in toddlers.
- PE would more effective than TP-CT in reducing post-traumatic symptoms of the toddlers' parents.
- These results will be preserved in a follow-up of 3-6 months post treatment. Following psychiatric assessment, 100 toddlers will be randomly assigned to PE and TP-CT (50 participants in each group).
Detailed description
Beyond what was detailed in the previous section of the brief summary, it should be noted that the toddlers will be assessed and treated at least 1 month post-trauma and at least 1 month after discharge from hospital in order to avoid acute reaction either to the traumatic event or to the medical procedures during their hospitalization and adjustment problems.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prolonged exposure | Experimental | Behavioral: Prolonged exposureSee intervention description |
| Child-parent Play Therapy | Active comparator | Behavioral: Child-parent Play Therapysee intervention description |
Who may qualify
- Ages
- 18 to 66 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Hebrew speaking toddlers with PTSD related to traumatic experience that occured at least 1 month prior to the study enrollment
- Toddlers whose parents are living together
Key exclusion criteria (8 listed)
- Toddlers which are still dealing with an active life threatening illness and are hence going through medical procedures.
- Toddlers with intelectual developmental disorder
- Toddlers with an active psychosis
- Toddlers with blindness or deafness
- Toddlers who are currently taking psychotropic medication
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 |
|---|---|---|
| Prolonged exposureThe PE treatment includes 12-15 60 minutes' sessions. The 2 main components of the treatment are psychoeducation about common reactions to trauma and in-vivo exposures (gradual exposure to trauma related situations and objects) and repeated recounting of the traumatic memory, Trauma memory recounting and in-vivo exposures are conducted during several successive sessions so the child learns that the exposures themselves pose no real harm to him, indicating that when one confronts what one is afraid of it becomes easier to manage. | Behavioural | Prolonged exposure |
| Child-parent Play TherapyIs consisted of 12-15 weekly 60 minute sessions of parent-child centered therapy it focus on establishing a trusting, empowering, and validating therapeutic relationship. Participants are allowed to choose when, how, and whether or not to address their trauma memory. Therapists provide active listening, empathy,and encouragement to talk about feelings and express belief in the participants ability to cope. In sessions 4 and 8, participants are asked how they feel about their trauma. With this exception, participants direct the sessions. | Behavioural | Child-parent Play Therapy |
Primary outcome
Change from baseline in post traumatic symptoms: clinical assessment and Young child ptsd checklist (YCPC, Scheeringa & Haslett, 2010).
Time frame: Parents' pre-treatment, post treatment and follow-up 3,6,12 months post treatment
Change from baseline in post traumatic symptoms will be assessed using the Classification of Mental Health and Developmental Disorders of Infancy and Early Childhood) and the Young Child PTSD Checklist (YCPC, Scheeringa \& Haslett, 2010). The YCPC assesses probable diagnosis formed the basis for the new DSM-5 disorder for posttraumatic stress disorder for children 6 years and younger.
4 secondary outcomes
Beck Depression Inventory (BDI)
Time frame: Parents' pre-treatment, post treatment (after 12-15 sessions) and follow-up 3-6 months post treatment
The Posttraumatic Stress Symptom Scale-Self report (PSS-SR; Foa, Riggs, Dancu & Rothbaum, 1993)
Time frame: Parents' pre-treatment, during treatment (every 2 sessions), post treatment (after 12-15 sessions) and follow-up 3-6 months post treatment
Posttraumatic Stress Cognitions Inventory (PTCI)
Time frame: Parents' pre-treatment, post treatment (after 12-15 sessions) and follow-up 3-6 months post treatment
Parenting Sense of Competence Scale )PSOC; Gibaud -Wallstton & Wandersman, 1978)
Time frame: Parents' pre-treatment, post treatment (after 12-15 sessions) and follow-up 3-6 months post treatment
Results and safety
The study was stopped early (reason given: Recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
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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.
Orit Krispin, Phd principal investigator
Schneider Children's Medical Center, Israel
Lilach Rachamim, Phd study director
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prolonged exposure and Child-parent Play Therapy in people with Post-Traumatic Stress Disorder in Children, run by Association for Children at Risk at 2 sites in Israel.
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 2 inclusion and 8 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: stopped early, as of the sponsor's last update on 11 Feb 2020. 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 Israel. 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?
The study was stopped early (reason given: Recruitment). Results are not available in the source record.
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?
Change from baseline in post traumatic symptoms: clinical assessment and Young child ptsd checklist (YCPC, Scheeringa & Haslett, 2010). (time frame: Parents' pre-treatment, post treatment and follow-up 3,6,12 months post treatment). 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 11 Feb 2020.