Relationship, Family (Foster)NCT03157895
A Trial of Connecting to Promote Foster Teen Well-Being
A study testing Connecting in people with Relationship, Family (Foster) and Substance Use Prevention, run by University of Washington at 1 site in United States.
Trial summary
This study evaluates the efficacy of a self-directed parenting program called Connecting in reducing risk of substance use and other risky behaviors in young foster teens (ages 11-15). Half of the participants will receive services as usual from the foster system, while half will participate in the Connecting program. Read more about this study
- Who is it for?
- Ages 11 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Relationship, Family (Foster), Substance Use Prevention
- What is being tested?
- Connecting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2016to 31 Oct 2020
- 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 11 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Foster youth ages 11-15 years
- In current placement 60+ days
- In relative/suitable adult care, in licensed relative/suitable adult care, in licensed foster care, in dependency guardianship
- Caregiver and teen speak English well enough to use the program manual and respond to survey questions
Who cannot join
- The teen has regularly used drugs or alcohol in the last 30 days
- The teen has been involved in the criminal justice system
- The placement is not viewed as stable
- The caregiver is not committed to a long-term placement
- The teen will not likely be in the placement for at least 6 months
- Group home placements and behavioral rehabilitative services placements
Trial locations and contacts
1 site in 1 country.
United States1 site
The Social Development Research Group, University of Washington
Seattle, Washington, 98115
About this study
Official title: A Trial of Connecting to Prevent Drug Abuse and Risky Behavior in Foster Teens
This study evaluates the efficacy of a self-directed parenting program called Connecting in reducing risk of substance use and other risky behaviors in young foster teens (ages 11-15). Half of the participants will receive services as usual from the foster system, while half will participate in the Connecting program. Connecting is a 10-week, self-directed parenting workbook with two digital video discs (DVDs). Families receive weekly telephone support as they complete the program.
- Being tested
- Connecting
- Keywords
- Foster Families
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ConnectingBehavioural
Also called Staying Connected With Your Teen
Connecting was adapted for use within the child welfare system from the Staying Connected With Your Teen program that has been demonstrated to prevent substance abuse, risky sexual behavior, and violence during adolescence.
| Study group | Role | What they receive |
|---|---|---|
| Program group | Experimental | This group receives the Connecting program with telephone support. It's anticipated the program will take up to 14 weeks to complete. Receives: Behavioral: Connecting |
| Comparison group | No intervention | This group receives Children's Administration services as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delay in drug use initiation
Monitoring the Future (Johnston et al., 2002). Communities that Care Youth Survey (CTC) (Hawkins \& Catalano, 2004).
Measured: 2 year follow up
Substance use frequency
Monitoring the Future (Johnston et al., 2002). Communities that Care Youth Survey (Hawkins \& Catalano, 2004).
Measured: 2 year follow up
Non-violent delinquent behavior frequency
Seattle Social Development Project (SSDP) (Hawkins et al., 1999). Raising Healthy Children (Catalano et al., 2005).
Measured: 2 year follow up
Violent delinquent behavior frequency
Seattle Social Development Project (Hawkins et al., 1999).
Measured: 2 year follow up
Delay in initiation of sexual activity
National Longitudinal Survey of Youth (Center for Human Research, 2003). Sexual Risk and Behavior Attitudes and Self Efficacy Scale (Basen Enquist et al., 1996). Communities that Care Youth Survey (Hawkins \& Catalano, 2004).
Measured: 2 year follow up
Secondary outcomes (4)
Residential placement stability
Child Welfare Administrative Data
Measured: 2 year follow up
Growth in caregiver/youth bonding
Communities that Care Youth Survey (Hawkins \& Catalano, 2004). Armsden \& Greenberg (1987).
Measured: 1 and 2 year follow up
Youth attitudes about HIV related risks
Sexual Risk and Behavior Attitudes and Self Efficacy Scale (Basen Enquist et al.,1996)
Measured: 1 and 2 year follow up
Youth attitudes favorable toward substance use
Communities that Care Youth Survey (Hawkins \& Catalano, 2004)
Measured: 1 and 2 year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study start1 Dec 2016
- Primary completion31 Oct 2020 (estimated)
- Study completion31 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Relationship, Family (Foster)Studies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Alliance for Child Welfare Excellence, Washington State Department of Social and Health Services
- Responsible party
- Principal investigator, Kevin Haggerty, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03157895
- Sponsor's protocol ID
- D012912S
- Status last verified
- Jul 2019
- First submitted
- 27 Apr 2017
- Last updated
- 31 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Haggerty KP, Barkan SE, Skinner M, Ben Packard W, Cole JJ. Feasibility of Connecting, a Substance-Abuse Prevention Program for Foster Teens and their Caregivers. J Soc Social Work Res. 2016 Winter;7(4):639-659. doi: 10.1086/686986. Epub 2016 Oct 18.
PubMed 27891209Barkan SE, Salazar AM, Estep K, Mattos LM, Eichenlaub C, Haggerty KP. Adapting an evidence based parenting program for child welfare involved teens and their caregivers. Child Youth Serv Rev. 2014 Jun;41:53-61. doi: 10.1016/j.childyouth.2014.03.006.
PubMed 26052172Storer HL, Barkan SE, Stenhouse LL, Eichenlaub C, Mallillin A, Haggerty KP. In search of connection: The foster youth and caregiver relationship. Child Youth Serv Rev. 2014 Jul;42:110-117. doi: 10.1016/j.childyouth.2014.04.008.
PubMed 26052173Storer HL, Barkan SE, Sherman EL, Haggerty KP, Mattos LM. Promoting Relationship Building and Connection: Adapting an Evidence-Based Parenting Program for Families Involved in the Child Welfare System. Child Youth Serv Rev. 2012 Sep 1;34(9):10.1016/j.childyouth.2012.05.017. doi: 10.1016/j.childyouth.2012.05.017.
PubMed 24347754Salazar AM, McCowan KJ, Cole JJ, Skinner ML, Noell BR, Colito JM, Haggerty KP, Barkan SE. Developing Relationship-Building Tools for Foster Families Caring for Teens who are LGBTQ2S. Child Welfare. 2018;96(2):75-97.
PubMed 29861503Haggerty KP, Barkan SE, Caouette JD, Skinner ML, Hanson KG. Two-Year Risk Behavior Outcomes from Connecting, a Prevention Program for Caregivers and Youth in Foster Care. Prev Sci. 2023 Jan;24(1):15-26. doi: 10.1007/s11121-022-01390-4. Epub 2022 Jul 4.
PubMed 35788868
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial of Connecting to Prevent Drug Abuse and Risky Behavior in Foster Teens
- ClinicalTrials.gov ID
- NCT03157895
- Acronym / sponsor ID
- D012912S
- Keywords
- Foster Families
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Alliance for Child Welfare Excellence, Washington State Department of Social and Health Services
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 31 Oct 2020 (estimated)
- Study completion
- 31 Oct 2020 (estimated)
- First posted
- 17 May 2017 (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 efficacy of a self-directed parenting program called Connecting in reducing risk of substance use and other risky behaviors in young foster teens (ages 11-15). Half of the participants will receive services as usual from the foster system, while half will participate in the Connecting program. Connecting is a 10-week, self-directed parenting workbook with two digital video discs (DVDs). Families receive weekly telephone support as they complete the program.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Program group | Experimental | Behavioral: ConnectingThis group receives the Connecting program with telephone support. It's anticipated the program will take up to 14 weeks to complete. |
| Comparison group | No intervention | –This group receives Children's Administration services as usual. |
Who may qualify
- Ages
- 11 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Foster youth ages 11-15 years
- In current placement 60+ days
- In relative/suitable adult care, in licensed relative/suitable adult care, in licensed foster care, in dependency guardianship
- Caregiver and teen speak English well enough to use the program manual and respond to survey questions
Key exclusion criteria (6 listed)
- The teen has regularly used drugs or alcohol in the last 30 days
- The teen has been involved in the criminal justice system
- The placement is not viewed as stable
- The caregiver is not committed to a long-term placement
- The teen will not likely be in the placement for at least 6 months
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 |
|---|---|---|
| ConnectingAlso: Staying Connected With Your TeenConnecting was adapted for use within the child welfare system from the Staying Connected With Your Teen program that has been demonstrated to prevent substance abuse, risky sexual behavior, and violence during adolescence. | Behavioural | Program group |
Primary outcome
Delay in drug use initiation
Time frame: 2 year follow up
Monitoring the Future (Johnston et al., 2002). Communities that Care Youth Survey (CTC) (Hawkins \& Catalano, 2004).
Substance use frequency
Time frame: 2 year follow up
Monitoring the Future (Johnston et al., 2002). Communities that Care Youth Survey (Hawkins \& Catalano, 2004).
Non-violent delinquent behavior frequency
Time frame: 2 year follow up
Seattle Social Development Project (SSDP) (Hawkins et al., 1999). Raising Healthy Children (Catalano et al., 2005).
Violent delinquent behavior frequency
Time frame: 2 year follow up
Seattle Social Development Project (Hawkins et al., 1999).
Delay in initiation of sexual activity
Time frame: 2 year follow up
National Longitudinal Survey of Youth (Center for Human Research, 2003). Sexual Risk and Behavior Attitudes and Self Efficacy Scale (Basen Enquist et al., 1996). Communities that Care Youth Survey (Hawkins \& Catalano, 2004).
4 secondary outcomes
Residential placement stability
Time frame: 2 year follow up
Growth in caregiver/youth bonding
Time frame: 1 and 2 year follow up
Youth attitudes about HIV related risks
Time frame: 1 and 2 year follow up
Youth attitudes favorable toward substance use
Time frame: 1 and 2 year follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2019.
- Background: PubMed 27891209Haggerty KP, Barkan SE, Skinner M, Ben Packard W, Cole JJ. Feasibility of Connecting, a Substance-Abuse Prevention Program for Foster Teens and their Caregivers. J Soc Social Work Res. 2016 Winter;7(4):639-659. doi: 10.1086/686986. Epub 2016 Oct 18.
- Background: PubMed 26052172Barkan SE, Salazar AM, Estep K, Mattos LM, Eichenlaub C, Haggerty KP. Adapting an evidence based parenting program for child welfare involved teens and their caregivers. Child Youth Serv Rev. 2014 Jun;41:53-61. doi: 10.1016/j.childyouth.2014.03.006.
- Background: PubMed 26052173Storer HL, Barkan SE, Stenhouse LL, Eichenlaub C, Mallillin A, Haggerty KP. In search of connection: The foster youth and caregiver relationship. Child Youth Serv Rev. 2014 Jul;42:110-117. doi: 10.1016/j.childyouth.2014.04.008.
- Background: PubMed 24347754Storer HL, Barkan SE, Sherman EL, Haggerty KP, Mattos LM. Promoting Relationship Building and Connection: Adapting an Evidence-Based Parenting Program for Families Involved in the Child Welfare System. Child Youth Serv Rev. 2012 Sep 1;34(9):10.1016/j.childyouth.2012.05.017. doi: 10.1016/j.childyouth.2012.05.017.
- Background: PubMed 29861503Salazar AM, McCowan KJ, Cole JJ, Skinner ML, Noell BR, Colito JM, Haggerty KP, Barkan SE. Developing Relationship-Building Tools for Foster Families Caring for Teens who are LGBTQ2S. Child Welfare. 2018;96(2):75-97.
- Derived from this study: PubMed 35788868Haggerty KP, Barkan SE, Caouette JD, Skinner ML, Hanson KG. Two-Year Risk Behavior Outcomes from Connecting, a Prevention Program for Caregivers and Youth in Foster Care. Prev Sci. 2023 Jan;24(1):15-26. doi: 10.1007/s11121-022-01390-4. Epub 2022 Jul 4.
- Individual participant dataSharing planned: Undecided
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Recruiting
Tele-PCIT for Healthy Relationships in Families At-Risk
Disruptive Behavior, Pediatrics
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Connecting in people with Relationship, Family (Foster) and Substance Use Prevention, run by University of Washington 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 31 Jul 2019. 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?
Results are not available in the source record.
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?
Delay in drug use initiation (time frame: 2 year follow up). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03157895, which also lists 6 linked publications.
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 31 Jul 2019.