Posttraumatic Stress DisorderNCT05155228
The Attachment, Regulation and Competency (ARC) Framework
A study testing Attachment Regulation and Competency and Treatment as usual in people with Posttraumatic Stress Disorder and Developmental Trauma Disorder, run by Justice Resource Institute at 1 site in United States.
Trial summary
This study evaluates the effectiveness of the Attachment Regulation and Competency (ARC) treatment framework in comparison to treatment as usual for reducing symptoms of PTSD and Developmental Trauma Disorder among children ages 8 to 16 with a history of exposure to multiple traumatic events. Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Posttraumatic Stress Disorder, Developmental Trauma Disorder
- What is being tested?
- Attachment Regulation and Competency and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2016to 31 Mar 2021
- 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 8 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- DTD diagnosis as measured by the DTD interview (using standard scoring criteria) or partial PTSD diagnosis as measured by the CAPS.
- A history of at least two forms of trauma, at least one of which must be interpersonal in nature (sexual, physical or psychological maltreatment, neglect, abandonment or impaired caregiving) as indicated on the Trauma History Profile (THP).
Who cannot join
- Serious illness that is not stabilized.
- GAF < 40.
- Past diagnosis of autism spectrum disorder, mental retardation, or schizophrenia.
- Current psychotic disorder or established organic impairment (e.g., TBI).
- Active suicidal risk, self-mutilation or homicidal behavior toward others within the past 3 months, as judged by the PI.
- Previous ARC treatment.
- Any other condition that might interfere with the person's capacity to give informed consent, or to adhere to the study protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
Trauma Center at JRI
Brookline, Massachusetts, 02446
About this study
Official title: Evaluation of the Attachment, Regulation and Competency (ARC) Framework for the Treatment of Complex Trauma in Children
This study evaluates the effectiveness of the Attachment Regulation and Competency (ARC) treatment framework in comparison to treatment as usual for reducing symptoms of PTSD and Developmental Trauma Disorder among children ages 8 to 16 with a history of exposure to multiple traumatic events.
Read the detailed description
The primary goal of this project is to expand the knowledge base in the field of trauma informed interventions by addressing current gaps in the evidence base through: a) evaluation of the efficacy of an innovative intervention designed specifically for children who experience complex trauma and their caregivers, thereby evaluating strategies that are most effective, and b) examining how ARC promotes protective factors (self-regulation, caregiver wellness), thereby supporting the health and well-being of complexly traumatized children and their families. The overall purpose of the randomized controlled trial (RCT) is to examine the effectiveness of ARC on the range of developmental disruptions and clinical symptoms that represent complex trauma, as well as its utility for increasing the adaptive functioning of children and families. In particular it is necessary to determine: 1) if ARC will demonstrate effectiveness in reducing sequelae of complex trauma as determined by a scientifically rigorous randomized control trial study design; 2) the extent to which ARC positively impacts resiliency factors (self-regulation, executive functioning, caregiver wellness), thereby serving to moderate or mediate change in symptoms and functioning; and 3) the impact of ARC across multiple levels of the family ecology, including the child, the caregiver-child relationship (i.e., attachment) and caregiver stress and wellness.
The specific objectives of this research project are the following:
- Recruit 182 children ages 8 to 16 with complex trauma and their adult caregivers, from clinical samples of children actively seeking treatment for mental health disorders and related difficulties from three community based outpatient clinics in the Commonwealth of Massachusetts.
- Conduct comprehensive, clinical interviews with participants and their caregivers to assess sequelae of complex trauma, to determine underlying resiliency factors and to gather information regarding trauma exposure history, over four study time points (pre-, mid-, and post-treatment and 6-month follow up).
- Deliver 24 sessions of once weekly ARC or TAU over a 6-month intervention period.
- Evaluate the efficacy of ARC and TAU using a variety of sophisticated statistical methods, such as growth curve modeling, multivariate analyses, and hierarchical linear regression analyses.
- Disseminate findings to: 1) the academic community via presentations at professional conferences and publications of data in peer reviewed journals; 2) the public, via the Trauma Center website, which received over 600,000 visitors in 2012, with 1,161,451 downloads of our manuscripts and resources for providers, consumers and state service agencies; and 3) the National Child Traumatic Stress Network (NCTSN) and Complex Trauma Treatment Network (CTTN) at annual network meetings, via their websites and through ongoing collaborations with partner network sites across the country.
- Being tested
- Attachment Regulation and Competency, Treatment as usual
- 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.
Attachment Regulation and CompetencyBehavioural
Trauma informed psychotherapy intervention for children with a history of exposure to trauma and their caregivers.
Treatment as usualBehavioural
Supportive psychotherapy
| Study group | Role | What they receive |
|---|---|---|
| Attachment Regulation and Competency | Experimental | Weekly individual psychotherapy for 24 weeks using the Attachment Regulation and Competency intervention. Receives: Behavioral: Attachment Regulation and Competency |
| Treatment as usual | Active comparator | Weekly individual psychotherapy for 24 weeks. Receives: Behavioral: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in baseline symptoms of PTSD at up to 24 weeks of treatment and 6-month follow up per the Clinician Administered PTSD Scale for Children and Adolescents, DSM 5 (CAPS-CA-DSM5)
The Clinician Administered PTSD Scale for Children and Adolescents, DSM 5 (CAPS-CA-DSM5) is a clinical research interview assessing the severity and frequency of DSM 5 symptoms of posttraumatic stress disorder over the previous month. The CAPS yields a total severity score based on assessment of 20 symptoms of PTSD that can range from 0 to 80, with higher scores indicating a greater severity of PTSD symptoms.
Measured: Change from baseline PTSD symptom severity at up to 24 weeks of treatment and 6-month follow up.
Change in baseline symptoms of Developmental Trauma Disorder (DTD) at up to 24 weeks of treatment and 6-month follow up
The Developmental Trauma Disorder Structured Interview (DTD-SI) is a clinician-administered semi-structured diagnostic interview designed for a parent or other primary caregiver of a child 8 to 17 years old to describe problems the child has in three categories of dysregulation: (1) Affective and Physiological, (2) Attentional and Behavioral, (3) Self and Relational. Questions and interviewer ratings parallel those of the K-SADS. The DTD-SI yields a total symptom score ranging from 0 to 25, with higher scores indicating greater severity of DTD symptoms.
Measured: Change from baseline DTD symptom severity at up to 24 weeks of treatment and 6-month follow up.
Secondary outcomes (5)
UCLA Posttraumatic Stress Disorder -Reaction Index for DSM 5 (PTSD-RI-5)
The UCLA Posttraumatic Stress Disorder -Reaction Index for DSM 5 (PTSD-RI-5) includes 31 items which map closely to the DSM 5 symptom criteria, yields a total score ranging from 0 to 124 with higher scores indicating more severe symptoms of PTSD, and provides clinical cut-off scores that can be used to measure severity of PTSD symptoms.
Measured: Change from baseline PTSD symptom severity at up to 12-weeks of treatment, up to 24 weeks of treatment and 6-month follow up.
Child Behavior Checklist (CBCL)
The Child Behavior Checklist is a 113 item, caregiver report of aggressive behavior, internalizing and externalizing symptoms, and dysregulation for youth ages 6-18 years of age, yielding nine syndrome scales and six DSM-oriented scales. The CBCL yields a Total Score ranging from 0 to 226, with higher scores indicating more severe emotional and behavioral problems.
Measured: Change from baseline in internalizing and externalizing problems at up to 12 weeks of treatment, up to 24 weeks of treatment, and 6-month follow up.
Behavior Rating Inventory of Executive Function - Parent Report (BRIEF-PR)
The Behavior Rating Inventory of Executive Function - Parent Version (BRIEF-PR) assesses various domains of executive function, including two broad scales; behavioral regulation (composed of inhibition, shifting and emotional control) and metacognition (composed of initiation, working memory, planning/organization, monitoring and organization of materials) and a global EF composite score. This 86-item measure yields a Global Executive Function score ranging from 0 to 176, with higher scores indicating poorer executive functions.
Measured: Change from baseline in executive dysfunction at up to 12 weeks of treatment, up to 24 weeks of treatment and 6-month follow up.
Trauma Symptom Checklist for Children (TSCC)
The Trauma Symptom Checklist for Children (TSCC) is 54-item child report for children ages 8-16 years to assess distress and related symptoms of trauma, including subscales for PTSD symptoms, dissociation, depression, anxiety, and sexual concerns. Scores for each subscale range from 9 to 36, with higher scores indicating greater symptom severity in a given domain.
Measured: Change from baseline in symptoms of dissociation at up to 12 weeks of treatment, up to 24 weeks of treatment, and 6-month follow up.
NIH Toolbox for the Assessment of Neurological and Behavioral Function, Cognition Domain
state-of-the-art computer-administered measures of cognitive function for use with subjects aged 3-85 years:
(a) Flanker Task: measure of inhibitory control in the context of selective visual attention. Youth indicate the left-right orientation of a stimulus (fish or arrow) while ignoring incongruent flankers (oriented the opposite way), (b) DCCS: measures cognitive flexibility. Youth sort stimuli using to a cued rule (shape/color), and (c) List Sorting: measures working memory, requiring maintenance/manipulation of information.
Measured: Change from baseline in executive function at up to 12 weeks of treatment, up to 24 weeks of treatment and 6-month follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2021
- Study start1 Sep 2016
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress DisorderStudies 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 Attachment, Regulation and Competency (ARC) Framework is an attachment focused model designed specifically for trauma-impacted children that incorporates principles of the following theoretical orientations: 1) developmental theory; 2) family systems theory; and 3) strengths-based approaches. The central goals of the ARC framework are to (a) support caregiving systems and enhance caregiver-child relationships ("Attachment"), (b) support children in developing the skills and tolerance for connecting to, identifying, and sharing internal experience and managing emotional and physiological states ("Regulation"), (c) build key capacities associated with resilience including the ability to engage in problem-solving and a positive / effective sense of self ("Competency"), and (d) process traumatic experiences.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Justice Resource Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hilary B Hodgdon, Ph.D., Principal investigator, Trauma Center at JRI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05155228
- Sponsor's protocol ID
- JRI 2016-03
- Status last verified
- Nov 2021
- First submitted
- 24 Mar 2017
- Last updated
- 13 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At this time IPD will not be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Attachment, Regulation and Competency (ARC) Framework for the Treatment of Complex Trauma in Children
- ClinicalTrials.gov ID
- NCT05155228
- Acronym / sponsor ID
- JRI 2016-03
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Justice Resource InstituteUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 13 Dec 2021 (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 the effectiveness of the Attachment Regulation and Competency (ARC) treatment framework in comparison to treatment as usual for reducing symptoms of PTSD and Developmental Trauma Disorder among children ages 8 to 16 with a history of exposure to multiple traumatic events.
Detailed description
The primary goal of this project is to expand the knowledge base in the field of trauma informed interventions by addressing current gaps in the evidence base through: a) evaluation of the efficacy of an innovative intervention designed specifically for children who experience complex trauma and their caregivers, thereby evaluating strategies that are most effective, and b) examining how ARC promotes protective factors (self-regulation, caregiver wellness), thereby supporting the health and well-being of complexly traumatized children and their families. The overall purpose of the randomized controlled trial (RCT) is to examine the effectiveness of ARC on the range of developmental disruptions and clinical symptoms that represent complex trauma, as well as its utility for increasing the adaptive functioning of children and families. In particular it is necessary to determine: 1) if ARC will demonstrate effectiveness in reducing sequelae of complex trauma as determined by a scientifically rigorous randomized control trial study design; 2) the extent to which ARC positively impacts resiliency factors (self-regulation, executive functioning, caregiver wellness), thereby serving to moderate or mediate change in symptoms and functioning; and 3) the impact of ARC across multiple levels of the family ecology, including the child, the caregiver-child relationship (i.e., attachment) and caregiver stress and wellness.
The specific objectives of this research project are the following:
- Recruit 182 children ages 8 to 16 with complex trauma and their adult caregivers, from clinical samples of children actively seeking treatment for mental health disorders and related difficulties from three community based outpatient clinics in the Commonwealth of Massachusetts.
- Conduct comprehensive, clinical interviews with participants and their caregivers to assess sequelae of complex trauma, to determine underlying resiliency factors and to gather information regarding trauma exposure history, over four study time points (pre-, mid-, and post-treatment and 6-month follow up).
- Deliver 24 sessions of once weekly ARC or TAU over a 6-month intervention period.
- Evaluate the efficacy of ARC and TAU using a variety of sophisticated statistical methods, such as growth curve modeling, multivariate analyses, and hierarchical linear regression analyses.
- Disseminate findings to: 1) the academic community via presentations at professional conferences and publications of data in peer reviewed journals; 2) the public, via the Trauma Center website, which received over 600,000 visitors in 2012, with 1,161,451 downloads of our manuscripts and resources for providers, consumers and state service agencies; and 3) the National Child Traumatic Stress Network (NCTSN) and Complex Trauma Treatment Network (CTTN) at annual network meetings, via their websites and through ongoing collaborations with partner network sites across the country.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The Attachment, Regulation and Competency (ARC) Framework is an attachment focused model designed specifically for trauma-impacted children that incorporates principles of the following theoretical orientations: 1) developmental theory; 2) family systems theory; and 3) strengths-based approaches. The central goals of the ARC framework are to (a) support caregiving systems and enhance caregiver-child relationships ("Attachment"), (b) support children in developing the skills and tolerance for connecting to, identifying, and sharing internal experience and managing emotional and physiological states ("Regulation"), (c) build key capacities associated with resilience including the ability to engage in problem-solving and a positive / effective sense of self ("Competency"), and (d) process traumatic experiences.
| Arm | Type | Receives |
|---|---|---|
| Attachment Regulation and Competency | Experimental | Behavioral: Attachment Regulation and CompetencyWeekly individual psychotherapy for 24 weeks using the Attachment Regulation and Competency intervention. |
| Treatment as usual | Active comparator | Behavioral: Treatment as usualWeekly individual psychotherapy for 24 weeks. |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- DTD diagnosis as measured by the DTD interview (using standard scoring criteria) or partial PTSD diagnosis as measured by the CAPS.
- A history of at least two forms of trauma, at least one of which must be interpersonal in nature (sexual, physical or psychological maltreatment, neglect, abandonment or impaired caregiving) as indicated on the Trauma History Profile (THP).
Key exclusion criteria (7 listed)
- Serious illness that is not stabilized.
- GAF < 40.
- Past diagnosis of autism spectrum disorder, mental retardation, or schizophrenia.
- Current psychotic disorder or established organic impairment (e.g., TBI).
- Active suicidal risk, self-mutilation or homicidal behavior toward others within the past 3 months, as judged by the PI.
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 |
|---|---|---|
| Attachment Regulation and CompetencyTrauma informed psychotherapy intervention for children with a history of exposure to trauma and their caregivers. | Behavioural | Attachment Regulation and Competency |
| Treatment as usualSupportive psychotherapy | Behavioural | Treatment as usual |
Primary outcome
Change in baseline symptoms of PTSD at up to 24 weeks of treatment and 6-month follow up per the Clinician Administered PTSD Scale for Children and Adolescents, DSM 5 (CAPS-CA-DSM5)
Time frame: Change from baseline PTSD symptom severity at up to 24 weeks of treatment and 6-month follow up.
The Clinician Administered PTSD Scale for Children and Adolescents, DSM 5 (CAPS-CA-DSM5) is a clinical research interview assessing the severity and frequency of DSM 5 symptoms of posttraumatic stress disorder over the previous month. The CAPS yields a total severity score based on assessment of 20 symptoms of PTSD that can range from 0 to 80, with higher scores indicating a greater severity of PTSD symptoms.
Change in baseline symptoms of Developmental Trauma Disorder (DTD) at up to 24 weeks of treatment and 6-month follow up
Time frame: Change from baseline DTD symptom severity at up to 24 weeks of treatment and 6-month follow up.
The Developmental Trauma Disorder Structured Interview (DTD-SI) is a clinician-administered semi-structured diagnostic interview designed for a parent or other primary caregiver of a child 8 to 17 years old to describe problems the child has in three categories of dysregulation: (1) Affective and Physiological, (2) Attentional and Behavioral, (3) Self and Relational. Questions and interviewer ratings parallel those of the K-SADS. The DTD-SI yields a total symptom score ranging from 0 to 25, with higher scores indicating greater severity of DTD symptoms.
5 secondary outcomes
UCLA Posttraumatic Stress Disorder -Reaction Index for DSM 5 (PTSD-RI-5)
Time frame: Change from baseline PTSD symptom severity at up to 12-weeks of treatment, up to 24 weeks of treatment and 6-month follow up.
Child Behavior Checklist (CBCL)
Time frame: Change from baseline in internalizing and externalizing problems at up to 12 weeks of treatment, up to 24 weeks of treatment, and 6-month follow up.
Behavior Rating Inventory of Executive Function - Parent Report (BRIEF-PR)
Time frame: Change from baseline in executive dysfunction at up to 12 weeks of treatment, up to 24 weeks of treatment and 6-month follow up.
Trauma Symptom Checklist for Children (TSCC)
Time frame: Change from baseline in symptoms of dissociation at up to 12 weeks of treatment, up to 24 weeks of treatment, and 6-month follow up.
NIH Toolbox for the Assessment of Neurological and Behavioral Function, Cognition Domain
Time frame: Change from baseline in executive function at up to 12 weeks of treatment, up to 24 weeks of treatment and 6-month follow up.
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 13 Dec 2021.
- Individual participant dataSharing planned: No. At this time IPD will not be shared with other researchers.
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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.
Hilary B Hodgdon, Ph.D. principal investigator
Trauma Center at JRI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Attachment Regulation and Competency and Treatment as usual in people with Posttraumatic Stress Disorder and Developmental Trauma Disorder, run by Justice Resource Institute 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 2 inclusion and 7 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 13 Dec 2021. 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. 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?
Change in baseline symptoms of PTSD at up to 24 weeks of treatment and 6-month follow up per the Clinician Administered PTSD Scale for Children and Adolescents, DSM 5 (CAPS-CA-DSM5) (time frame: Change from baseline PTSD symptom severity at up to 24 weeks of treatment and 6-month follow up.). The study lists 2 primary outcomes in all. 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 13 Dec 2021.