- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01765166
Parent Treatment for Child Social Adjustment (SSGRIN-PG)
Continuing the Research and Development of Parent Treatment for Child Social Adjustment
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
North Carolina
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Cary, North Carolina, United States, 27513
- 3-C Institute for Social Development
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Durham, North Carolina, United States, 27705
- Duke Child And Family Study Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:children ages 8-12 experiencing peer difficulties who are English speaking. To confirm eligibility regarding peer difficulties, 3-C staff will conduct a brief (5 minute) phone-survey with parents for two sub-scales of the Social Skills Rating System: Parent Form (SSRS; Gresham & Elliott, 1990). To be eligible for participation, a child must have a standard score either (a) less than one standard deviation (std) on the Social Skills Scale (<84%ile) or (b) greater than one std on the Problem Behavior Scale (>84%ile).
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Exclusion Criteria:SSGRIN group therapy is not recommended for extremely aggressive children (DeRosier, 2005), so any child scoring higher than two std on the Externalizing Problem Behavior Scale (>97%ile) will be excluded from participation and referral sources to other appropriate community resources will be given to parents.
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Control(ChO)
Children receive traditional SSGRIN child treatment with no parent involvement
|
All children will receive traditional SSGRIN(Social Skills Group Intervention), but parents will vary in the level of parent treatment.
Families will be randomly assigned to one of four treatment conditions(approximately 25% each): (a) Traditional SSGRIN child treatment with no parent involvement (ChO), (b) SSGRIN child treatment plus parent attention control (PAC), (c) SSGRIN child treatment plus Parent Guide-Home-study treatment (PG-HS), or (d) SSGRIN child treatment plus traditional Parent Guide treatment (PG).
|
|
Experimental: Parent attention control(PAC)
Children will participate in traditional SSGRIN treatment, and parents will participate in a weekly support group to meet with other parents regarding their child's peer relations and behavior.
The support group will meet for a parallel amount of time (1 hour/week for 10 weeks) and be facilitated by two parents with no SSGRIN or Parent Guide experience.
The PAC condition will reflect the social support functions of a parenting group, but no therapeutic skills training or other instructional materials will be provided.
|
All children will receive traditional SSGRIN(Social Skills Group Intervention), but parents will vary in the level of parent treatment.
Families will be randomly assigned to one of four treatment conditions(approximately 25% each): (a) Traditional SSGRIN child treatment with no parent involvement (ChO), (b) SSGRIN child treatment plus parent attention control (PAC), (c) SSGRIN child treatment plus Parent Guide-Home-study treatment (PG-HS), or (d) SSGRIN child treatment plus traditional Parent Guide treatment (PG).
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Experimental: Parent Guide-Home Study(PG-HS)
Children will receive traditional SSGRIN treatment, and parents will receive the Parent Guide to SSGRIN training by participating in the online Parent Guide Home Study (PG-HS) course.
The PG-HS course will include all instructional content and materials for the in-person Parent Guide course, but parent will receive the training online.
|
All children will receive traditional SSGRIN(Social Skills Group Intervention), but parents will vary in the level of parent treatment.
Families will be randomly assigned to one of four treatment conditions(approximately 25% each): (a) Traditional SSGRIN child treatment with no parent involvement (ChO), (b) SSGRIN child treatment plus parent attention control (PAC), (c) SSGRIN child treatment plus Parent Guide-Home-study treatment (PG-HS), or (d) SSGRIN child treatment plus traditional Parent Guide treatment (PG).
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Experimental: Parent Guide(PG)
Children will receive traditional SSGRIN treatment and parents will receive parallel traditional in-person SSGRIN-Parent Guide treatment.
|
All children will receive traditional SSGRIN(Social Skills Group Intervention), but parents will vary in the level of parent treatment.
Families will be randomly assigned to one of four treatment conditions(approximately 25% each): (a) Traditional SSGRIN child treatment with no parent involvement (ChO), (b) SSGRIN child treatment plus parent attention control (PAC), (c) SSGRIN child treatment plus Parent Guide-Home-study treatment (PG-HS), or (d) SSGRIN child treatment plus traditional Parent Guide treatment (PG).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Children's social skills
Time Frame: pre-treatment, post-treatment, 6 months post-treatment, 12 months post-treatment
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Child Acquired Learning Questionnaire
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pre-treatment, post-treatment, 6 months post-treatment, 12 months post-treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Parental, child, and dyadic behavioral observations
Time Frame: pre-treatment, post-treatment, 6 months post-treatment, 12 months post-treatment
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Parent-child social problem solving assessment
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pre-treatment, post-treatment, 6 months post-treatment, 12 months post-treatment
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Melissa E DeRosier, Ph.D., 3-C Institute for Social Development
- Principal Investigator: Amanda W Harrell, Ph.D., 3-C Institute for Social Development
- Principal Investigator: Allan K Chrisman, M.D., Duke University
Publications and helpful links
General Publications
- DeRosier ME. Building relationships and combating bullying: effectiveness of a school-based social skills group intervention. J Clin Child Adolesc Psychol. 2004 Mar;33(1):196-201. doi: 10.1207/S15374424JCCP3301_18.
- DeRosier ME, Marcus SR. Building friendships and combating bullying: effectiveness of S.S.GRIN at one-year follow-up. J Clin Child Adolesc Psychol. 2005 Mar;34(1):140-50. doi: 10.1207/s15374424jccp3401_13.
- DeRosier, M.E. & Gilliom, M. (2007). Effectiveness of a parent training program for improving children's social behavior. Journal of Child and Family Studies, 16, 660-670.
- DeRosier, M.E. (1995). Summary of 3-C Program Results with 3rd through 5th graders in the WCPSS.
- DeRosier, M.E. (2002). Group interventions and exercises for enhancing children's communication,cooperation, and confidence. Sarasota, FL: Professional Resources Press.
- DeRosier, M.E. (2006). Social Skills Group Intervention - Parent Guide(S.S.GRIN-PG). Cary, NC: SELmedia,Inc.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Pro00019396
- 2R44MH065718-04 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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