NCT04443504

Brief Summary

The current study aims to examine the effectiveness of an online, self-paced post-adoption intervention to improve understanding, well-being, and connection within adoptive families.To evaluate the effectiveness of this intervention, a mixed method, pre-post design with two conditions will be used. Data from standard, reliable measures and free-response items will be collected pre- and post-intervention from participants in two conditions: the intervention condition and the waitlist condition. The intervention condition involves receiving the intervention immediately following pre-assessments; the waitlist condition involves receiving the intervention approximately 3 months after the intervention condition once all data collection is completed. The study aims to answer six research questions. Each research question involves analyses of the differences between the intervention and waitlist conditions across multiple time points.

  1. 1.What is the intervention's effect on improving awareness of the needs of different family members and understanding how to meet these needs? Hypothesis 1: At post-intervention, parents in the intervention condition will report an improved awareness of the needs of each family member and greater understanding of how to meet these needs.
  2. 2.What is the intervention's effect on parent well-being (i.e., parenting confidence and parenting stress) from pre- to post-intervention? Hypothesis 2: Parents in the intervention condition will report increased parenting confidence and trending decreases in parenting stress from pre- to post-intervention compared to those in the waitlist condition.
  3. 3.What is the intervention's effect on child well-being (i.e., self-esteem and emotional and behavioral problems) from pre- to post-intervention? Hypothesis 3: Children in the intervention condition will report increased self-esteem and trending decreases in emotional and behavioral problems from pre- to post-intervention compared to those in the waitlist condition.
  4. 4.What is the intervention's effect on the quality of the parent-child relationship from pre- to post-intervention? Hypothesis 4: Both parents and children in the intervention condition will report improved connection in the parent-child relationship from pre- to post-intervention compared to those in the waitlist condition.
  5. 5.As an exploratory question, what is the intervention's effect on the quality of the sibling relationship from pre- to post-intervention? Hypothesis 5: Children in the intervention condition will report an improvement in the quality of their relationship with their sibling(s) from pre- to post-intervention compared to children in the waitlist condition.
  6. 6.What is the intervention's effect on connection and communication within the overall family system from pre- to post-intervention? Hypothesis 6: Parents and children in the intervention condition will report increased family communication and family connection in the whole family system from pre- to post-intervention compared to parents and children in the waitlist condition.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
148

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

June 18, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 23, 2020

Completed
8 days until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2021

Completed
Last Updated

October 12, 2021

Status Verified

October 1, 2021

Enrollment Period

9 months

First QC Date

June 18, 2020

Last Update Submit

October 11, 2021

Conditions

Keywords

post-adoption interventionTrust-Based Relational Interventionadoption

Outcome Measures

Primary Outcomes (2)

  • Change in Family Cohesion

    Family Adaptability and Cohesion Scale IV

    through study completion, an average of 6 months

  • Change in Parent and Child Relationship

    Inventory of Parent and Peer Attachment-Revised, Child-Parent Relationship Scale-Short Form

    through study completion, an average of 6 months

Secondary Outcomes (5)

  • Change in Parenting Stress

    through study completion, an average of 6 months

  • Change in Parenting Competence

    through study completion, an average of 6 months

  • Change in Child Self-Esteem

    through study completion, an average of 6 months

  • Change in Child Emotional and Behavioral Problems

    through study completion, an average of 6 months

  • Change in Sibling Relationship

    through study completion, an average of 6 months

Study Arms (2)

Intervention Group

EXPERIMENTAL
Behavioral: The Connected Family Series

Waitlist Group

NO INTERVENTION

The waitlist group will receive the intervention 3 months after the intervention group.

Interventions

The intervention is an online, self-paced post-adoption family intervention that occurs over a 4-week period to support adoptive families post-adoption.

Intervention Group

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Study participants must be families who have legally adopted or have legal permanency of all children in their family.
  • Study participants must have at least one adopted child in the family.
  • Adoptive families who have at least two children with at least one child being 12 years or older. It does not matter if the child who is 12 years or older is an adopted or biological child in the family.
  • All members of the family must be willing to participate in the intervention and all members 12 years and older must be willing to participate in the research assessments.

You may not qualify if:

  • Families who are current foster homes.
  • Families who have at least one member of the family who has recently been hospitalized for psychiatric issues.
  • Families in which at least one member of the family is at risk of harm to self or others.
  • Two-parent households in which the marriage is a consistent source of conflict.
  • Families who have participated in Hope Connection 2.0, a therapeutic family camp.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Christian University

Fort Worth, Texas, 76110, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two groups will be created using random assignment: an intervention group and a waitlist control group who will receive the intervention 3 months after the intervention group
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Graduate Research Assistant

Study Record Dates

First Submitted

June 18, 2020

First Posted

June 23, 2020

Study Start

July 1, 2020

Primary Completion

April 5, 2021

Study Completion

April 5, 2021

Last Updated

October 12, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations