The Attachment, Regulation and Competency (ARC) Framework

NCT05155228 | Completed

• 1 other identifier: JRI 2016-03
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Posttraumatic Stress Disorder; Developmental Trauma Disorder

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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)

  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)

  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)

  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)

  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

  Change from baseline in executive function at up to 12 weeks of treatment, up to 24 weeks of treatment and 6-month follow up.

Other Outcomes (3)

• Behavioral and Emotional Rating Scale, Second Edition (BERS-2)

  Change from baseline in resilience at up to 12 weeks of treatment, up to 24 weeks of treatment and 6-month follow up.

• Emotion Regulation Checklist (ERC)

  Change from baseline in emotion regulation at up to 12 weeks of treatment, up to 24 weeks of treatment and 6-month follow up.

• Brief Symptom Inventory (BSI)

  Change from baseline in caregiver mental health symptoms at up to 12 weeks of treatment, up to 24 weeks of treatment and 6-month follow up.

Study Arms (2)

Attachment Regulation and Competency

EXPERIMENTAL

Weekly individual psychotherapy for 24 weeks using the Attachment Regulation and Competency intervention.

Behavioral: Attachment Regulation and Competency

Treatment as usual

ACTIVE COMPARATOR

Weekly individual psychotherapy for 24 weeks.

Behavioral: Treatment as usual

Interventions

Attachment Regulation and Competency BEHAVIORAL

Trauma informed psychotherapy intervention for children with a history of exposure to trauma and their caregivers.

Attachment Regulation and Competency

Treatment as usual BEHAVIORAL

Supportive psychotherapy

Treatment as usual

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Justice Resource Institute: lead

Study Sites (1)

Trauma Center at JRI

Brookline, Massachusetts, 02446, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Mental Competency; Therapeutics

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Jurisprudence; Social Control, Formal; Health Care Economics and Organizations

Study Officials

• Hilary B Hodgdon, Ph.D.

  Trauma Center at JRI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 24, 2017
• First Posted: December 13, 2021
• Study Start: September 1, 2016
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: December 13, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)