Adoption-specific Treatment Prevention Pilot Trial (ADAPT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by University of California, Los Angeles
Sponsor:
Collaborator:
Center for Adoption Support and Education
Information provided by (Responsible Party):
Dr. Jeanne Miranda, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01744951
First received: November 28, 2012
Last updated: July 2, 2013
Last verified: July 2013
  Purpose

This study seeks to pilot a manualized adoption-specific intervention aimed at providing a preventive intervention for families adopting children ages 5-14 years where family reunification has been terminated and the family is moving toward adoption or who have adopted children from foster care in the last three years. This work will fill a major gap in services to children and families and is developed to improve mental health and family functioning of children adopted from foster care, as well as decrease adoption disruptions. President Clinton's 1997 adoption initiative, The Adoption and Safe Families ACT (ASFA), along with subsequent Congressional initiatives, have provided incentives to States and subsidies for adopting older children with a resultant increase in rates of adoption from foster care from 26,000 in 1995 to 53,000 (stabilized annual rate) beginning in 2002. The mean age at adoption from foster care is now 6 years old. These older children have histories of physical and sexual abuse, neglect, and multiple placements, all factors that predict behavior problems over time. To address this gap in our knowledge of providing care for this vulnerable group, we have developed a manualized adoption-specific intervention for families adopting children from foster care. Because adoptive children generally enter homes with stable, well-functioning parents, interventions may be particularly effective in helping the children adjust and their parents learn to understand and manage children with difficult past histories.

The aim of this current pilot trial is to test this intervention designed to improve the outcomes for children adopted from foster care through a randomized trial. Our hypothesis is that this manualized adoption-specific intervention will be more effective than care as usual in improving child mental health and family functioning outcomes; specifically, families and children who have been randomized to the manualized adoption-specific intervention will show better outcomes on the post-treatment measures and the 3 month follow-up than on the pre-treatment measures than the care as usual families and children.


Condition Intervention Phase
Prevent Disorders in Children Adopted From Foster Care
Behavioral: ADAPT
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Evaluate the Adoption-specific Prevention Treatment Program (ADAPT)

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Parent Weekly Report [ Time Frame: Participants will be followed for the duration of the therapeutic intervention, an expected average of 24 weeks. ] [ Designated as safety issue: No ]
    The Parent Weekly Report consists of two measures: Brief Problem Checklist (Chorpita et al., 2010 and Parent Daily Report (Chamberlain & Reid, 1987).


Secondary Outcome Measures:
  • Number of child participants whose internalizing and externalizing behaviors improve [ Time Frame: 0 weeks, 24 weeks, 36 weeks ] [ Designated as safety issue: No ]
    Child participants' internalizing and externalizing behaviors will be measured at the three distinct times by using both child and parent measures: 1. Emotional Distress and Functioning:Children's Depression Inventory, Screen for Childhood Anxiety Related Emotional Disorders (SCARED),Child PTSD Symptom Scale (CPSS),Achenbach Child Behavior Checklists and Teacher Report Forms (CBCL),Children's Global Assessment Scale (CGAS) 2.Targeted Resilience Factors: Emotion Regulation Checklist (ER Checklist),Kidcope 3.Understanding of Adoption: Adoption Dynamics Questionnaire (ADQ),Children's Beliefs about Adoption Scale (CBAAS) 4.Family Environment and Parental Distress,Family Environment Scale (FES),Brief Symptom Inventory (BSI) 5.Attachment and Parenting: Inventory of Parent and Peer Attachment (IPPA) 6.Trauma Exposure: Modified Life Events Scale (LES) 7.Process Variables: Therapeutic Alliance Scale for Children (TASC),Working Alliance Inventory (WAI),Consumer Satisfaction Questionnaire


Estimated Enrollment: 60
Study Start Date: October 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ADAPT
ADAPT is a manualized intervention with eight treatment modules designed as an early intervention for children, ages 5-14, who are being adopted from foster care and their adoptive parent/s.
Behavioral: ADAPT

ADAPT consists of the following modules/sessions:

Module 1: Trust, positive coping strategies, and behavior management; Module 2: Developmental understanding of adoption experience; Module 3: Substance abuse prevention; Module 4: Loss and grief issues about birth family and foster care; Module 5: Attachment/joining with adoptive family; Module 6: Search for identity/self -esteem; Module 7: Adoption and the outside world; Module 8: Trauma Treatment (if appropriate)

No Intervention: Care as usual
Children, ages 5-14, and their adoptive parent/s will receive care as usual in the treatment setting.

  Eligibility

Ages Eligible for Study:   5 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Children being adopted from foster care, ages 5-14
  • Children (within above age range) who have been adopted in the last three years
  • Family reunification services have been terminated

Exclusion Criteria:

  • Children with the following Diagnostic and Statistical Manual psychiatric disorders will be excluded from study participation: Pervasive Developmental Disorders (e.g. Asperger's, autism, mental retardation, or psychotic disorder as known to the parents
  • Children will be excluded if the child has a major neurological disorder or a major medical illness that would interfere with participation in the study
  • Children who pose a significant risk for dangerousness to self or others that makes participating inadvisable
  • Children and/or parents who are non-English speaking and unable to complete treatment without a translator will not be included
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01744951

Contacts
Contact: Jeanne Miranda, Ph.D. 310-794-3710 JMMiranda@mednet.ucla.edu
Contact: Jill Waterman, Ph.D. 310-825-3240 Waterman@psych.ucla.edu

Locations
United States, California
Children's Bureau of Southern California Recruiting
Los Angeles, California, United States, 90007
Contact: Franz Jordan, Ph.D.       franzjordan@all4kids.org   
Sub-Investigator: Franz Jordan, Ph.D.         
UCLA TIES for Familes Recruiting
Los Angeles, California, United States, 90095
Contact: Jill Waterman, Ph.D.    310-825-3240    Waterman@psych.ucla.edu   
Sub-Investigator: Jill Waterman, Ph.D.         
United States, Maryland
Center for Adoption Support and Education Recruiting
Burtonsville, Maryland, United States, 20866
Contact: Debbie Rilley, M.S.       riley@adoptionsupport.org   
Sub-Investigator: Debbie Riley, M.S.         
Sponsors and Collaborators
University of California, Los Angeles
Center for Adoption Support and Education
Investigators
Principal Investigator: Jeanne Miranda, Ph.D. University of California, Los Angeles
  More Information

No publications provided

Responsible Party: Dr. Jeanne Miranda, Professor in Residence, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01744951     History of Changes
Other Study ID Numbers: ADAPT-02, UCLA IRB/IRB# 12-001024
Study First Received: November 28, 2012
Last Updated: July 2, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
Adoption
Foster care
Substance abuse
Older children
Mental health

ClinicalTrials.gov processed this record on October 20, 2014