Parent Treatment for Child Social Adjustment (SSGRIN-PG)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01765166
First received: December 17, 2012
Last updated: January 8, 2013
Last verified: January 2013
  Purpose

This Competing Renewal project continues the research and development of a parent-focused intervention, Parent Guide to SSGRIN, which parallels an established child-focused intervention [Social Skills GRoup INtervention (S.S. GRIN); for children ages 8-12 years], in order to teach and reinforce the same social skills and concepts within the home environment. A primary goal is to address questions of relative impact, longer-term treatment benefits, and differential treatment effects of the Parent Guide training on children's social skill development across settings and populations.


Condition Intervention
Interpersonal Relations
Behavioral: SSGRIN-Parent Guide

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Continuing the Research and Development of Parent Treatment for Child Social Adjustment

Further study details as provided by Duke University:

Primary Outcome Measures:
  • Children's social skills [ Time Frame: pre-treatment, post-treatment, 6 months post-treatment, 12 months post-treatment ] [ Designated as safety issue: No ]
    Child Acquired Learning Questionnaire


Secondary Outcome Measures:
  • Parental, child, and dyadic behavioral observations [ Time Frame: pre-treatment, post-treatment, 6 months post-treatment, 12 months post-treatment ] [ Designated as safety issue: No ]
    Parent-child social problem solving assessment


Enrollment: 240
Study Start Date: January 2010
Study Completion Date: June 2012
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Control(ChO)
Children receive traditional SSGRIN child treatment with no parent involvement
Behavioral: SSGRIN-Parent Guide
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.
Behavioral: SSGRIN-Parent Guide
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 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.
Behavioral: SSGRIN-Parent Guide
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 Guide(PG)
Children will receive traditional SSGRIN treatment and parents will receive parallel traditional in-person SSGRIN-Parent Guide treatment.
Behavioral: SSGRIN-Parent Guide
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).

Detailed Description:

This Competing Renewal project continues the research and development of a parent-focused intervention, Parent Guide to SSGRIN, which parallels an established child-focused intervention [Social Skills GRoup INtervention (S.S. GRIN); for children ages 8-12 years], in order to teach and reinforce the same social skills and concepts within the home environment. A primary goal of this Competing Renewal is to conduct a rigorous, large-scale, longitudinal research project that is adequately powered to address questions of relative impact, longer-term treatment benefits, and differential treatment effects of the Parent Guide training on children's social skill development across settings and populations. Though schools often struggle with how to increase parent involvement in school-based programs, school officials report that it is infeasible for them to conduct the full series of in-person parent training groups as the Parent Guide's current curriculum demands; therefore, a second goal of this Competing Renewal is to test a Home-study version of the Parent Guide to bridge training into the home environment. The Home-study version of the Parent Guide will be included as a separate treatment condition within the effectiveness trial. This clinical trial will provide S.S.GRIN treatment for 240 children ages 8-12 and vary the level of parent intervention to determine the effectiveness of the two variations of Parent Guide to S.S.GRIN. Parents will be randomly assigned to one of four conditions: (1) Parent Guide treatment; (2) Parent Guide-Home Study treatment; (3) parent attention control; or (4) no treatment. Pre-treatment, post-treatment, 6-month post-treatment, and 12 month post-treatment data will be collected assessing children's social skill development from children, parents, and teachers. Based on past clinical experience, the probability of adverse psychological and behavioral effects from behavioral intervention is very low; however, to ensure participants' safety, a data and safety monitoring plan will be in place.

  Eligibility

Ages Eligible for Study:   8 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01765166

Locations
United States, North Carolina
3-C Institute for Social Development
Cary, North Carolina, United States, 27513
Duke Child and Family Study Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
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
  More Information

Additional Information:
Publications:
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01765166     History of Changes
Other Study ID Numbers: Pro00019396, 2R44MH065718-04
Study First Received: December 17, 2012
Last Updated: January 8, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Social Skill Training
Social Interaction
Peer relations

ClinicalTrials.gov processed this record on April 17, 2014