NCT01744951

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 28, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 7, 2012

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

April 20, 2026

Status Verified

August 1, 2018

Enrollment Period

4.9 years

First QC Date

November 28, 2012

Last Update Submit

April 16, 2026

Conditions

Keywords

AdoptionFoster careSubstance abuseOlder childrenMental health

Outcome Measures

Primary Outcomes (1)

  • Parent Weekly Report

    The Parent Weekly Report consists of two measures: Brief Problem Checklist (Chorpita et al., 2010 and Parent Daily Report (Chamberlain \& Reid, 1987).

    Participants will be followed for the duration of the therapeutic intervention, an expected average of 24 weeks.

Secondary Outcomes (1)

  • Number of child participants whose internalizing and externalizing behaviors improve

    0 weeks, 24 weeks, 36 weeks

Study Arms (2)

ADAPT

EXPERIMENTAL

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

Care as usual

NO INTERVENTION

Children, ages 5-14, and their adoptive parent/s will receive care as usual in the treatment setting.

Interventions

ADAPTBEHAVIORAL

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)

ADAPT

Eligibility Criteria

Age5 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Children's Bureau of Southern California

Los Angeles, California, 90007, United States

Location

UCLA TIES for Familes

Los Angeles, California, 90095, United States

Location

UCLA TIES for Families South Bay

Torrance, California, 90502, United States

Location

Center for Adoption Support and Education

Burtonsville, Maryland, 20866, United States

Location

Children's Home Society North Carolina

Greensboro, North Carolina, 27405, United States

Location

MeSH Terms

Conditions

Substance-Related DisordersPsychological Well-Being

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersPersonal SatisfactionBehavior

Study Officials

  • Jeanne Miranda, Ph.D.

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2012

First Posted

December 7, 2012

Study Start

October 1, 2012

Primary Completion

September 1, 2017

Study Completion

December 1, 2018

Last Updated

April 20, 2026

Record last verified: 2018-08

Locations